To provide for the importation of prescription drugs.

TEXT OF AMENDMENTS

______

SA 983. Mr. VITTER submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the end of subtitle E of title II, insert the following:

SEC. __. COUNTERFEIT-RESISTANT TECHNOLOGIES FOR PRESCRIPTION
DRUGS.

(a) Required Technologies.--The Secretary of Health and
Human Services shall require that the packaging of any
prescription drug incorporate--
(1) radio frequency identification (RFID) tagging
technology, or similar trace and track technologies that have
an equivalent function;
(2) tamper-indicating technologies; and
(3) blister security packaging when possible.
(b) Use of Technologies.--
(1) Authorized uses.--The Secretary shall require that
technologies described in subsection (a)(1) be used
exclusively to authenticate the pedigree of prescription
drugs, including by--
(A) implementing inventory control;
(B) tracking and tracing prescription drugs;
(C) verifying shipment or receipt of prescription drugs;
(D) authenticating finished prescription drugs; and
(E) electronically authenticating the pedigree of
prescription drugs.
(2) Privacy protection.--The Secretary shall prohibit
technologies required by subsection (a)(1) from containing or
transmitting any information that may be used to identify a
health care practitioner or the prescription drug consumer.
(3) Prohibition against advertising.--The Secretary shall
prohibit technologies required by subsection (a)(1) from
containing or transmitting any advertisement or information
about prescription drug indications or off-label prescription
drug uses.
(c) Recommended Technologies.--The Secretary shall
encourage the manufacturers and distributors of prescription
drugs to incorporate into the packaging of such drugs, in
addition to the technologies required under subsection (a),
overt optically variable counterfeit-resistant technologies
that--
(1) are visible to the naked eye, providing for visual
identification of prescription drug authenticity without the
need for readers, microscopes, lighting devices, or scanners;
(2) are similar to technologies used by the Bureau of
Engraving and Printing to secure United States currency;
(3) are manufactured and distributed in a highly secure,
tightly controlled environment; and
(4) incorporate additional layers of non-visible covert
security features up to and including forensic capability.
(d) Standards for Packaging.--
(1) Multiple elements.--For the purpose of making it more
difficult to counterfeit the packaging of prescription drugs,
the Secretary shall require manufacturers of prescription
drugs to incorporate the technologies described in paragraphs
(1), (2), and (3) of subsection (a), and shall encourage
manufacturers and distributors of prescription drugs to
incorporate the technologies described in subsection (c),
into multiple elements of the physical packaging of the
drugs, including--
(A) blister packs, shrink wrap, package labels, package
seals, bottles, and boxes; and
(B) at the item level.
(2) Labeling of shipping container.--Shipments of
prescription drugs shall include a label on the shipping
container that incorporates the technologies described in
subsection (a)(1), so that members of the supply chain
inspecting the packages will be able to determine the
authenticity of the shipment. Chain of custody procedures
shall apply to such labels and shall include procedures
applicable to contractual agreements for the use and
distribution of the labels, methods to audit the use of the
labels, and database access for the relevant governmental
agencies for audit or verification of the use and
distribution of the labels.
(e) Penalty.--A prescription drug is deemed to be
misbranded for purposes of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) if the packaging or
labeling of the drug is in violation of a requirement or
prohibition applicable to the drug under subsection (a), (b),
or (d).
(f) Transitional Provisions; Effective Dates.--
(1) National specified list of susceptible prescription
drugs.--
(A) Initial publication.--Not later than 180 days after the
date of the enactment of

[[Page S5403]]

this Act, the Secretary shall publish in the Federal Register
a list, to be known as the National Specified List of
Susceptible Prescription Drugs, consisting of not less than
30 of the prescription drugs that are most frequently subject
to counterfeiting in the United States (as determined by the
Secretary).
(B) Revision.--Not less than annually through the end of
calendar year 2010, the Secretary shall review and, as
appropriate, revise the National Specified List of
Susceptible Prescription Drugs. The Secretary may not revise
the List to include fewer than 30 prescription drugs.
(2) Effective dates.--The Secretary shall implement the
requirements and prohibitions of subsections (a), (b), and
(d)--
(A) with respect to prescription drugs on the National
Specified List of Susceptible Prescription Drugs, beginning
not later than the earlier of--
(i) 1 year after the initial publication of such List; or
(ii) December 31, 2008; and
(B) with respect to all prescription drugs, beginning not
later than December 31, 2011.
(3) Authorized uses during transitional period.--In lieu of
the requirements specified in subsection (b)(1), for the
period beginning on the effective date applicable under
paragraph (2)(A) and ending on the commencement of the
effective date applicable under paragraph (2)(B), the
Secretary shall require that technologies described in
subsection (a)(1) be used exclusively to verify the
authenticity of prescription drugs.
(g) Definitions.--In this Act:
(1) The term ``pedigree''--
(A) means the history of each prior sale, purchase, or
trade of the prescription drug involved to a distributor or
retailer of the drug (including the date of the transaction
and the names and addresses of all parties to the
transaction); and
(B) excludes information about the sale, purchase, or trade
of the drug to the drug consumer.
(2) The term ``prescription drug'' means a drug subject to
section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(b)(1)).
(3) The term ``Secretary'' means the Secretary of Health
and Human Services.

______

SA 984. Mr. VITTER submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

TITLE--IMPORTATION OF PRESCRIPTION DRUGS

SEC. _01. SHORT TITLE.

This Act may be cited as the ``Pharmaceutical Market Access
Act of 2007''.

SEC. _02. FINDINGS.

Congress finds as follows:
(1) Americans unjustly pay up to 1,000 percent more to fill
their prescriptions than consumers in other countries.
(2) The United States is the world's largest market for
pharmaceuticals yet consumers still pay the world's highest
prices.
(3) An unaffordable drug is neither safe nor effective.
Allowing and structuring the importation of prescription
drugs ensures access to affordable drugs, thus providing a
level of safety to American consumers they do not currently
enjoy.
(4) Prescription drug costs are a leading cause of the
growth in United States health care spending, which reached
nearly $2,000,000,0000 in 2005, of which spending on
prescription drugs amounted to $200,700,000,000.
(5) According to the Congressional Budget Office, American
seniors alone will spend $1,800,000,000,000 on
pharmaceuticals over the next 10 years.
(6) Allowing open pharmaceutical markets could save
American consumers at least $635,000,000,000 of their own
money.

SEC. _03. PURPOSES.

The purposes of this title are to--
(1) give all Americans immediate relief from the
outrageously high cost of pharmaceuticals;
(2) reverse the perverse economics of the American
pharmaceutical market;
(3) allow the importation of prescription drugs only if the
drugs and facilities where such drugs are manufactured are
approved by the Food and Drug Administration, and to exclude
pharmaceutical narcotics;
(4) ensure continued integrity to the prescription drug
supply of the United States by--
(A) requiring that imported prescription drugs be packaged
and shipped using counterfeit-resistant technologies;
(B) requiring Internet pharmacies to register with the
United States Government for Americans to verify authenticity
before purchases over the Internet;
(C) requiring all foreign sellers to register with United
States Government and submit to facility inspections by the
Government without prior notice; and
(D) limiting the eligible countries from which prescription
drugs may be imported to Canada, member countries of the
European Union, and other highly industrialized nations with
safe pharmaceutical infrastructures.

SEC. _04. AMENDMENTS TO SECTION 804 OF THE FEDERAL FOOD,
DRUG, AND COSMETIC ACT.

(a) Definitions.--Section 804(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 384(a)) is amended to read as
follows:
``(a) Definitions.--In this section:
``(1) Importer.--The term `importer' means a pharmacy,
group of pharmacies, pharmacist, or wholesaler.
``(2) Permitted country.--The term `permitted country'
means Australia, Canada, Israel, Japan, New Zealand,
Switzerland, South Africa, Austria, Belgium, Denmark,
Finland, France, Germany, Greece, Ireland, Italy, Luxemburg,
Netherlands, Portugal, Spain, Sweden, the United Kingdom,
Iceland, Liechtenstein, and Norway, except that the
Secretary--
``(A) may add a country, union, or economic area as a
permitted country for purposes of this section if the
Secretary determines that the country, union, or economic
area has a pharmaceutical infrastructure that is
substantially equivalent or superior to the pharmaceutical
infrastructure of the United States, taking into
consideration pharmacist qualifications, pharmacy storage
procedures, the drug distribution system, the drug dispensing
system, and market regulation; and
``(B) may remove a country, union, or economic area as a
permitted country for purposes of this section if the
Secretary determines that the country, union, or economic
area does not have such a pharmaceutical infrastructure.
``(3) Pharmacist.--The term `pharmacist' means a person
licensed by the relevant governmental authority to practice
pharmacy, including the dispensing and selling of
prescription drugs.
``(4) Pharmacy.--The term `pharmacy' means a person that is
licensed by the relevant governmental authority to engage in
the business of selling prescription drugs that employs 1 or
more pharmacists.
``(5) Prescription drug.--The term `prescription drug'
means a drug subject to section 503(b), other than--
``(A) a controlled substance (as defined in section 102 of
the Controlled Substances Act (21 U.S.C. 802));
``(B) a biological product (as defined in section 351 of
the Public Health Service Act (42 U.S.C. 262));
``(C) an infused drug (including a peritoneal dialysis
solution);
``(D) an intravenously injected drug;
``(E) a drug that is inhaled during surgery; or
``(F) a drug which is a parenteral drug, the importation of
which pursuant to subsection (b) is determined by the
Secretary to pose a threat to the public health, in which
case section 801(d)(1) shall continue to apply.
``(6) Qualifying drug.--The term `qualifying drug' means a
prescription drug that--
``(A) is approved pursuant to an application submitted
under section 505(b)(1); and
``(B) is not--
``(i) a drug manufactured through 1 or more biotechnology
processes;
``(ii) a drug that is required to be refrigerated; or
``(iii) a photoreactive drug.
``(7) Qualifying internet pharmacy.--The term `qualifying
Internet pharmacy' means a registered exporter that dispenses
qualifying drugs to individuals over an Internet website.
``(8) Qualifying laboratory.--The term `qualifying
laboratory' means a laboratory in the United States that has
been approved by the Secretary for the purposes of this
section.
``(9) Registered exporter.--The term `registered exporter'
means a person that is in the business of exporting a drug to
persons in the United States (or that seeks to be in such
business), for which a registration under this section has
been approved and is in effect.
``(10) Wholesaler.--
``(A) In general.--The term `wholesaler' means a person
licensed as a wholesaler or distributor of prescription drugs
in the United States under section 503(e)(2)(A).
``(B) Exclusion.--The term `wholesaler' does not include a
person authorized to import drugs under section 801(d)(1).''.
(b) Regulations.--Section 804(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 384(b)) is amended to read as
follows:
``(b) Regulations.--Not later than 180 days after the date
of enactment of the Pharmaceutical Market Access Act of 2007,
the Secretary, after consultation with the United States
Trade Representative and the Commissioner of the Bureau of
Customs and Border Protection, shall promulgate regulations
permitting pharmacists, pharmacies, and wholesalers to import
qualifying drugs from permitted countries into the United
States.''.
(c) Limitation.--Section 804(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 384(c)) is amended by striking
``prescription drug'' each place it appears and inserting
``qualifying drug''.
(d) Information and Records.--Section 804(d)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(d)(1)) is
amended--
(1) by striking subparagraph (G) and redesignating
subparagraphs (H) through (N) as subparagraphs (G) through
(M), respectively;
(2) in subparagraph (H) (as so redesignated), by striking
``telephone number, and professional license number (if
any)'' and inserting ``and telephone number''; and

[[Page S5404]]

(3) in subparagraph (L) (as so redesignated), by striking
``(J) and (L)'' and inserting ``(I) and (K)''.
(e) Testing.--Section 804(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 384(e)) is amended to read as
follows:
``(e) Testing.--The regulations under subsection (b) shall
require that the testing described under subparagraphs (I)
and (K) of subsection (d)(1) be conducted by the importer of
the qualifying drug, unless the qualifying drug is subject to
the requirements under section 505C for counterfeit-resistant
technologies.''.
(f) Registration of Exporters; Inspections.--Section 804(f)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
384(f)) is amended to read as follows:
``(f) Registration of Exporters; Inspections.--
``(1) In general.--Any person that seeks to be a registered
exporter (referred to in this subsection as the `registrant')
shall submit to the Secretary a registration that includes
the following:
``(A) The name of the registrant and identification of all
places of business of the registrant that relate to
qualifying drugs, including each warehouse or other facility
owned or controlled by, or operated for, the registrant;
``(B) An agreement by the registrant to--
``(i) make its places of business that relate to qualifying
drugs (including warehouses and other facilities owned or
controlled by, or operated for, the exporter) and records
available to the Secretary for on-site inspections, without
prior notice, for the purpose of determining whether the
registrant is in compliance with this Act's requirements;
``(ii) export only qualifying drugs;
``(iii) export only to persons authorized to import the
drugs;
``(iv) notify the Secretary of a recall or withdrawal of a
qualifying drug distributed in a permitted country to or from
which the registrant has exported or imported, or intends to
export or import, to the United States;
``(v) monitor compliance with registration conditions and
report any noncompliance promptly;
``(vi) submit a compliance plan showing how the registrant
will correct violations, if any; and
``(vii) promptly notify the Secretary of changes in the
registration information of the registrant.
``(2) Notice of approval or disapproval.--
``(A) In general.--Not later than 90 days after receiving a
completed registration from a registrant, the Secretary
shall--
``(i) notify such registrant of receipt of the
registration;
``(ii) assign such registrant a registration number; and
``(iii) approve or disapprove the application.
``(B) Disapproval of application.--
``(i) In general.--The Secretary shall disapprove a
registration, and notify the registrant of such disapproval,
if the Secretary has reason to believe that such registrant
is not in compliance with a registration condition.
``(ii) Subsequent approval.--The Secretary may subsequently
approve a registration that was denied under clause (i) if
the Secretary finds that the registrant is in compliance with
all registration conditions.
``(3) List.--The Secretary shall--
``(A) maintain an up-to-date list of registered exporters
(including qualifying Internet pharmacies that sell
qualifying drugs to individuals);
``(B) make such list available to the public on the
Internet site of the Food and Drug Administration and via a
toll-free telephone number; and
``(C) update such list promptly after the approval of a
registration under this subsection.
``(4) Education of consumers.--The Secretary shall carry
out activities, by use of the Internet website and toll-free
telephone number under paragraph (3), that educate consumers
with regard to the availability of qualifying drugs for
import for personal use under this section, including
information on how to verify whether an exporter is
registered.
``(5) Inspection of importers and registered exporters.--
The Secretary shall inspect the warehouses, other facilities,
and records of importers and registered exporters as often as
the Secretary determines necessary to ensure that such
importers and registered exporters are in compliance with
this section.''.
(g) Suspension of Importation.--Section 804(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(g)) is
amended by--
(1) striking ``and the Secretary determines that the public
is adequately protected from counterfeit and violative
prescription drugs being imported under subsection (b)''; and
(2) by adding after the period at the end the following:
``The Secretary shall reinstate the importation by a specific
importer upon a determination by the Secretary that the
violation has been corrected and that the importer has
demonstrated that further violations will not occur. This
subsection shall not apply to a prescription drug imported by
an individual, or to a prescription drug shipped to an
individual by a qualifying Internet pharmacy.''.
(h) Waiver Authority for Individuals.--Section 804(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(j))
is amended to read as follows:
``(j) Importation by Individuals.--
``(1) In general.--Not later than 180 days after the
enactment of the Pharmaceutical Market Access Act of 2007,
the Secretary shall by regulation permit an individual to
import a drug from a permitted country to the United States
if the drug is--
``(A) a qualifying drug;
``(B) imported from a licensed pharmacy or qualifying
Internet pharmacy;
``(C) for personal use by an individual, or family member
of the individual, not for resale;
``(D) in a quantity that does not exceed a 90-day supply
during any 90-day period; and
``(E) accompanied by a copy of a prescription for the drug,
which--
``(i) is valid under applicable Federal and State laws; and
``(ii) was issued by a practitioner who is authorized to
administer prescription drugs.
``(2) Drugs dispensed outside the united states.--An
individual may import a drug from a country that is not a
permitted country if--
``(A) the drug was dispensed to the individual while the
individual was in such country, and the drug was dispensed in
accordance with the laws and regulations of such country;
``(B) the individual is entering the United States and the
drug accompanies the individual at the time of entry;
``(C) the drug is approved for commercial distribution in
the country in which the drug was obtained;
``(D) the drug does not appear to be adulterated; and
``(E) the quantity of the drug does not exceed a 14-day
supply.''.
(i) Repeal of Certain Provisions.--Section 804 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) is
amended by striking subsections (l) and (m).

SEC. _05. REGISTRATION FEES.

Subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 397f et seq.) is amended by adding at
the end the following:

``PART 5--FEES RELATING TO PRESCRIPTION DRUG IMPORTATION

``SEC. 740A. FEES RELATING TO PRESCRIPTION DRUG IMPORTATION.

``(a) Registration Fee.--The Secretary shall establish a
registration fee program under which a registered exporter
under section 804 shall be required to pay an annual fee to
the Secretary in accordance with this subsection.
``(b) Collection.--
``(1) Collection on initial registration.--A fee under this
section shall be payable for the fiscal year in which the
registered exporter first submits a registration under
section 804 (or reregisters under that section if that person
has withdrawn its registration and subsequently reregisters)
in a amount of $10,000, due on the date the exporter first
submits a registration to the Secretary under section 804.
``(2) Collection in subsequent years.--After the fee is
paid for the first fiscal year, the fee described under this
subsection shall be payable on or before October 1 of each
year.
``(3) One fee per facility.--The fee shall be paid only
once for each registered exporter for a fiscal year in which
the fee is payable.
``(c) Fee Amount.--
``(1) In general.--Subject to subsection (b)(1), the amount
of the fee shall be determined each year by the Secretary and
shall be based on the anticipated costs to the Secretary of
enforcing the amendments made by the Pharmaceutical Market
Access Act of 2007 in the subsequent fiscal year.
``(2) Limitation.--
``(A) In general.--The aggregate total of fees collected
under this section shall not exceed 1 percent of the total
price of drugs exported annually to the United States by
registered exporters under this section.
``(B) Reasonable estimate.--Subject to the limitation
described in subparagraph (A), a fee under this subsection
for an exporter shall be an amount that is a reasonable
estimate by the Secretary of the annual share of the exporter
of the volume of drugs exported by exporters under this
section.
``(d) Use of Fees.--The fees collected under this section
shall be used for the sole purpose of administering this
section with respect to registered exporters, including the
costs associated with--
``(1) inspecting the facilities of registered exporters,
and of other entities in the chain of custody of a qualifying
drug;
``(2) developing, implementing, and maintaining a system to
determine registered exporters' compliance with the
registration conditions under the Pharmaceutical Market
Access Act of 2007, including when shipments of qualifying
drugs are offered for import into the United States; and
``(3) inspecting such shipments, as necessary, when offered
for import into the United States to determine if any such
shipment should be refused admission.
``(e) Annual Fee Setting.--The Secretary shall establish,
60 days before the beginning of each fiscal year beginning
after September 30, 2007, for that fiscal year, registration
fees.
``(f) Effect of Failure to Pay Fees.--
``(1) Due date.--A fee payable under this section shall be
paid by the date that is 30 days after the date on which the
fee is due.
``(2) Failure to pay.--If a registered exporter subject to
a fee under this section fails to pay the fee, the Secretary
shall not

[[Page S5405]]

permit the registered exporter to engage in exportation to
the United States or offering for exportation prescription
drugs under this Act until all such fees owed by that person
are paid.
``(g) Reports.--
``(1) Fee establishment.--Not later than 60 days before the
beginning of each fiscal year, the Secretary shall--
``(A) publish registration fees under this section for that
fiscal year;
``(B) hold a meeting at which the public may comment on the
recommendations; and
``(C) provide for a period of 30 days for the public to
provide written comments on the recommendations.
``(2) Performance and fiscal report.--Beginning with fiscal
year 2007, not later than 60 days after the end of each
fiscal year during which fees are collected under this
section, the Secretary shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report that describes--
``(A) implementation of the registration fee authority
during the fiscal year; and
``(B) the use by the Secretary of the fees collected during
the fiscal year for which the report is made.''.

SEC. _06. COUNTERFEIT-RESISTANT TECHNOLOGY.

(a) Misbranding.--Section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352; deeming drugs and devices to
be misbranded) is amended by adding at the end the following:
``(z) If it is a drug subject to section 503(b), unless the
packaging of such drug complies with the requirements of
section 505C for counterfeit-resistant technologies.''.
(b) Requirements.--Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 505B the following:

``SEC. 505C. COUNTERFEIT-RESISTANT TECHNOLOGIES.

``(a) Incorporation of Counterfeit-Resistant Technologies
Into Prescription Drug Packaging.--The Secretary shall
require that the packaging of any drug subject to section
503(b) incorporate--
``(1) overt optically variable counterfeit-resistant
technologies that are described in subsection (b) and comply
with the standards of subsection (c); or
``(2) technologies that have an equivalent function of
security, as determined by the Secretary.
``(b) Eligible Technologies.--Technologies described in
this subsection--
``(1) shall be visible to the naked eye, providing for
visual identification of product authenticity without the
need for readers, microscopes, lighting devices, or scanners;
``(2) shall be similar to that used by the Bureau of
Engraving and Printing to secure United States currency;
``(3) shall be manufactured and distributed in a highly
secure, tightly controlled environment; and
``(4) should incorporate additional layers of non-visible
covert security features up to and including forensic
capability.
``(c) Standards for Packaging.--
``(1) Multiple elements.--For the purpose of making it more
difficult to counterfeit the packaging of drugs subject to
section 503(b), manufacturers of the drugs shall incorporate
the technologies described in subsection (b) into multiple
elements of the physical packaging of the drugs, including
blister packs, shrink wrap, package labels, package seals,
bottles, and boxes.
``(2) Labeling of shipping container.--Shipments of drugs
described in subsection (a) shall include a label on the
shipping container that incorporates the technologies
described in subsection (b), so that officials inspecting the
packages will be able to determine the authenticity of the
shipment. Chain of custody procedures shall apply to such
labels and shall include procedures applicable to contractual
agreements for the use and distribution of the labels,
methods to audit the use of the labels, and database access
for the relevant governmental agencies for audit or
verification of the use and distribution of the labels.
``(d) Effective Date.--This section shall take effect 180
days after the date of enactment of the Pharmaceutical Market
Access Act of 2007.''.

SEC. _07. PROHIBITED ACTS.

Section 301 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331) is amended by inserting after subsection (k) the
following:
``(l) The failure to register in accordance with section
804(f) or to import or offer to import a prescription drug in
violation of a suspension order under section 804(g).''.

SEC. _08. PATENTS.

Section 271 of title 35, United States Code, is amended--
(1) by redesignating subsections (h) and (i) as subsections
(i) and (j), respectively; and
(2) by inserting after subsection (g) the following:
``(h) It shall not be an act of infringement to use, offer
to sell, or sell within the United States or to import into
the United States any patented invention under section 804
(21 U.S.C. 384) of the Federal Food, Drug, and Cosmetic Act
that was first sold abroad by or under authority of the owner
or licensee of such patent.''.

SEC. _09. OTHER ENFORCEMENT ACTIONS.

(a) In General.--Section 804 of the Federal Food, Drug, and
Cosmetic Act (as amended in section _04) is amended by adding
at the end the following:
``(l) Unfair or Discriminatory Acts and Practices.--
``(1) In general.--It is unlawful for a manufacturer,
directly or indirectly (including by being a party to a
licensing or other agreement) to--
``(A) discriminate by charging a higher price for a
prescription drug sold to a person in a permitted country
that exports a prescription drug to the United States under
this section than the price that is charged to another person
that is in the same country and that does not export a
prescription drug into the United States under this section;
``(B) discriminate by charging a higher price for a
prescription drug sold to a person that distributes, sells,
or uses a prescription drug imported into the United States
under this section than the price that is charged to another
person in the United States that does not import a
prescription drug under this section, or that does not
distribute, sell, or use such a drug;
``(C) discriminate by denying supplies of a prescription
drug to a person in a permitted country that exports a
prescription drug to the United States under this section or
distributes, sells, or uses a prescription drug imported into
the United States under this section;
``(D) discriminate by publicly, privately, or otherwise
refusing to do business with a person in a permitted country
that exports a prescription drug to the United States under
this section or distributes, sells, or uses a prescription
drug imported into the United States under this section;
``(E) discriminate by specifically restricting or delaying
the supply of a prescription drug to a person in a permitted
country that exports a prescription drug to the United States
under this section or distributes, sells, or uses a
prescription drug imported into the United States under this
section;
``(F) cause there to be a difference (including a
difference in active ingredient, route of administration,
dosage form, strength, formulation, manufacturing
establishment, manufacturing process, or person that
manufactures the drug) between a prescription drug for
distribution in the United States and the drug for
distribution in a permitted country for the purpose of
restricting importation of the drug into the United States
under this section;
``(G) refuse to allow an inspection authorized under this
section of an establishment that manufactures a prescription
drug that may be imported or offered for import under this
section;
``(H) fail to conform to the methods used in, or the
facilities used for, the manufacturing, processing, packing,
or holding of a prescription drug that may be imported or
offered for import under this section to good manufacturing
practice under this Act;
``(I) become a party to a licensing or other agreement
related to a prescription drug that fails to provide for
compliance with all requirements of this section with respect
to such prescription drug or that has the effect of
prohibiting importation of the drug under this section; or
``(J) engage in any other action that the Federal Trade
Commission determines to discriminate against a person that
engages in, or to impede, delay, or block the process for,
the importation of a prescription drug under this section.
``(2) Affirmative defense.--It shall be an affirmative
defense to a charge that a person has discriminated under
subparagraph (A), (B), (C), (D), or (E) of paragraph (1) that
the higher price charged for a prescription drug sold to a
person, the denial of supplies of a prescription drug to a
person, the refusal to do business with a person, or the
specific restriction or delay of supplies to a person is not
based, in whole or in part, on--
``(A) the person exporting or importing a prescription drug
into the United States under this section; or
``(B) the person distributing, selling, or using a
prescription drug imported into the United States under this
section.
``(3) Presumption and affirmative defense.--
``(A) Presumption.--A difference (including a difference in
active ingredient, route of administration, dosage form,
strength, formulation, manufacturing establishment,
manufacturing process, or person that manufactures the drug)
created after January 1, 2007, between a prescription drug
for distribution in the United States and the drug for
distribution in a permitted country shall be presumed under
paragraph (1)(H) to be for the purpose of restricting
importation of the drug into the United States under this
section.
``(B) Affirmative defense.--It shall be an affirmative
defense to the presumption under subparagraph (A) that--
``(i) the difference was required by the country in which
the drug is distributed; or
``(ii) the Secretary has determined that the difference was
necessary to improve the safety or effectiveness of the drug.
``(4) Effect of subsection.--
``(A) Sales in other countries.--This subsection applies
only to the sale or distribution of a prescription drug in a
country if the manufacturer of the drug chooses to sell or
distribute the drug in the country. Nothing in this
subsection shall be construed to compel the manufacturer of a
drug to distribute or sell the drug in a country.
``(B) Discounts to insurers, health plans, pharmacy benefit
managers, and covered entities.--Nothing in this subsection
shall be construed to--

[[Page S5406]]

``(i) prevent or restrict a manufacturer of a prescription
drug from providing discounts to an insurer, health plan,
pharmacy benefit manager in the United States, or covered
entity in the drug discount program under section 340B in
return for inclusion of the drug on a formulary;
``(ii) require that such discounts be made available to
other purchasers of the prescription drug; or
``(iii) prevent or restrict any other measures taken by an
insurer, health plan, or pharmacy benefit manager to
encourage consumption of such prescription drug.
``(C) Charitable contributions.--Nothing in this subsection
shall be construed to--
``(i) prevent a manufacturer from donating a prescription
drug, or supplying a prescription drug at nominal cost, to a
charitable or humanitarian organization, including the United
Nations and affiliates, or to a government of a foreign
country; or
``(ii) apply to such donations or supplying of a
prescription drug.
``(5) Enforcement.--
``(A) Unfair or deceptive act or practice.--A violation of
this subsection shall be treated as a violation of a rule
defining an unfair or deceptive act or practice prescribed
under section 18(a)(1)(B) of the Federal Trade Commission
Act.
``(B) Actions by the commission.--The Federal Trade
Commission--
``(i) shall enforce this subsection in the same manner, by
the same means, and with the same jurisdiction, powers, and
duties as though all applicable terms and provisions of the
Federal Trade Commission Act were incorporated into and made
a part of this section; and
``(ii) may seek monetary relief threefold the damages
sustained.
``(6) Actions by states.--
``(A) In general.--
``(i) Civil actions.--The attorney general of a State may
bring a civil action on behalf of the residents of the State,
and persons doing business in the State, in a district court
of the United States of appropriate jurisdiction for a
violation of paragraph (1) to--

``(I) enjoin that practice;
``(II) enforce compliance with this subsection;
``(III) obtain damages, restitution, or other compensation
on behalf of residents of the State and persons doing
business in the State, including threefold the damages; or
``(IV) obtain such other relief as the court may consider
to be appropriate.

``(ii) Notice.--

``(I) In general.--Before filing an action under clause
(i), the attorney general of the State involved shall provide
to the Federal Trade Commission--

``(aa) written notice of that action; and
``(bb) a copy of the complaint for that action.

``(II) Exemption.--Subclause (I) shall not apply with
respect to the filing of an action by an attorney general of
a State under this paragraph, if the attorney general
determines that it is not feasible to provide the notice
described in that subclause before filing of the action. In
such case, the attorney general of a State shall provide
notice and a copy of the complaint to the Federal Trade
Commission at the same time as the attorney general files the
action.

``(B) Intervention.--
``(i) In general.--On receiving notice under subparagraph
(A)(ii), the Commission shall have the right to intervene in
the action that is the subject of the notice.
``(ii) Effect of intervention.--If the Commission
intervenes in an action under subparagraph (A), it shall have
the right--

``(I) to be heard with respect to any matter that arises in
that action; and
``(II) to file a petition for appeal.

``(C) Construction.--For purposes of bringing any civil
action under subparagraph (A), nothing in this subsection
shall be construed to prevent an attorney general of a State
from exercising the powers conferred on the attorney general
by the laws of that State to--
``(i) conduct investigations;
``(ii) administer oaths or affirmations; or
``(iii) compel the attendance of witnesses or the
production of documentary and other evidence.
``(D) Actions by the commission.--
``(i) In general.--In any case in which an action is
instituted by or on behalf of the Commission for a violation
of paragraph (1), a State may not, during the pendency of
that action, institute an action under subparagraph (A) for
the same violation against any defendant named in the
complaint in that action.
``(ii) Intervention.--An attorney general of a State may
intervene, on behalf of the residents of that State, in an
action instituted by the Commission.
``(iii) Effect of intervention.--If an attorney general of
a State intervenes in an action instituted by the Commission,
such attorney general shall have the right--

``(I) to be heard with respect to any matter that arises in
that action; and
``(II) to file a petition for appeal.

``(E) Venue.--Any action brought under subparagraph (A) may
be brought in the district court of the United States that
meets applicable requirements relating to venue under section
1391 of title 28, United States Code.
``(F) Service of process.--In an action brought under
subparagraph (A), process may be served in any district in
which the defendant--
``(i) is an inhabitant; or
``(ii) may be found.
``(G) Limitation of actions.--Any action under this
paragraph to enforce a cause of action under this subsection
by the Federal Trade Commission or the attorney general of a
State shall be forever barred unless commenced within 5 years
after the Federal Trade Commission, or the attorney general,
as the case may be, knew or should have known that the cause
of action accrued. No cause of action barred under existing
law on the effective date of the Pharmaceutical Market Access
Act of 2007 shall be revived by such Act.
``(H) Measurement of damages.--In any action under this
paragraph to enforce a cause of action under this subsection
in which there has been a determination that a defendant has
violated a provision of this subsection, damages may be
proved and assessed in the aggregate by statistical or
sampling methods, by the computation of illegal overcharges
or by such other reasonable system of estimating aggregate
damages as the court in its discretion may permit without the
necessity of separately proving the individual claim of, or
amount of damage to, persons on whose behalf the suit was
brought.
``(I) Exclusion on duplicative relief.--The district court
shall exclude from the amount of monetary relief awarded in
an action under this paragraph brought by the attorney
general of a State any amount of monetary relief which
duplicates amounts which have been awarded for the same
injury.
``(7) Effect on antitrust laws.--Nothing in this subsection
shall be construed to modify, impair, or supersede the
operation of the antitrust laws. For the purpose of this
subsection, the term `antitrust laws' has the meaning given
it in the first section of the Clayton Act, except that it
includes section 5 of the Federal Trade Commission Act to the
extent that such section 5 applies to unfair methods of
competition.
``(8) Manufacturer.--In this subsection, the term
`manufacturer' means any entity, including any affiliate or
licensee of that entity, that is engaged in--
``(A) the production, preparation, propagation,
compounding, conversion, or processing of a prescription
drug, either directly or indirectly by extraction from
substances of natural origin, or independently by means of
chemical synthesis, or by a combination of extraction and
chemical synthesis; or
``(B) the packaging, repackaging, labeling, relabeling, or
distribution of a prescription drug.''.
(b) Regulations.--The Federal Trade Commission shall
promulgate regulations to carry out the enforcement program
under section 804(l) of the Federal Food, Drug, and Cosmetic
Act (as added by subsection (a)).
(c) Suspension and Termination of Exporters.--Section
804(g) of the Federal Food, Drug, and Cosmetic Act (as
amended by section _04(g)) (21 U.S.C. 384(g)) is amended by--
(1) striking ``Suspension of Importation.--The Secretary''
and inserting ``Suspension of Importation.--
``(1) In general.--The Secretary''; and
(2) adding at the end the following:
``(2) Suspension and termination of exporters.--
``(A) Suspension.--With respect to the effectiveness of a
registration submitted under subsection (f) by a registered
exporter:
``(i) Subject to clause (ii), if the Secretary determines,
after notice and opportunity for a hearing, that the
registered exporter has failed to maintain substantial
compliance with all registration conditions, the Secretary
may suspend the registration.
``(ii) If the Secretary determines that, under color of the
registration, the registered exporter has exported a drug
that is not a qualifying drug, or a drug that does not meet
the criteria under this section, or has exported a qualifying
drug to an individual in violation of this section, the
Secretary shall immediately suspend the registration. A
suspension under the preceding sentence is not subject to the
provision by the Secretary of prior notice, and the Secretary
shall provide to the registered exporter involved an
opportunity for a hearing not later than 10 days after the
date on which the registration is suspended.
``(iii) The Secretary may reinstate the registration,
whether suspended under clause (i) or (ii), if the Secretary
determines that the registered exporter has demonstrated that
further violations of registration conditions will not occur.
``(B) Termination.--The Secretary, after notice and
opportunity for a hearing, may terminate the registration
under subsection (f) of a registered exporter if the
Secretary determines that the registered exporter has engaged
in a pattern or practice of violating 1 or more registration
conditions, or if on 1 or more occasions the Secretary has
under subparagraph (A)(ii) suspended the registration of the
registered exporter. The Secretary may make the termination
permanent, or for a fixed period of not less than 1 year.
During the period in which the registration of a registered
exporter is terminated, any registration submitted under
subsection (f) by such exporter or a person who is a partner
in the export enterprise or a principal officer in such
enterprise, and any registration prepared with the assistance
of such exporter or such a person, has no legal effect under
this section.''.

[[Page S5407]]

SEC. _10. AUTHORIZATION OF APPROPRIATIONS.

There are authorized to be appropriated such sums as may be
necessary to carry out this title (and the amendments made by
this title).

______

SA 985. Mr. BROWNBACK (for himself and Mr. Brown) submitted an
amendment intended to be proposed by him to the bill S. 1082, to amend
the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the
prescription drug user fee provisions, and for other purposes; which
was ordered to lie on the table; as follows:

At the appropriate place, insert the following:

SEC. __. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL
DISEASES.

Subchapter A of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at
the end the following:

``SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR
TROPICAL DISEASES.

``(a) Definitions.--In this section:
``(1) AIDS.--The term `AIDS' means the acquired immune
deficiency syndrome.
``(2) AIDS drug.--The term `AIDS drug' means a drug
indicated for treating HIV.
``(3) HIV.--The term `HIV' means the human immunodeficiency
virus, the pathogen that causes AIDS.
``(4) Neglected or tropical disease.--The term `neglected
or tropical disease' means--
``(A) HIV, malaria, tuberculosis, and related diseases; or
``(B) any other infectious disease that disproportionately
affects poor and marginalized populations, including those
diseases targeted by the Special Programme for Research and
Training in Tropical Diseases cosponsored by the United
Nations Development Program, UNICEF, the World Bank, and the
World Health Organization.
``(5) Priority review.--The term `priority review', with
respect to a new drug application described in paragraph (6),
means review and action by the Secretary on such application
not later than 180 days after receipt by the Secretary of
such application, pursuant to the Manual of Policies and
Procedures of the Food and Drug Administration.
``(6) Priority review voucher.--The term `priority review
voucher' means a voucher issued by the Secretary to the
sponsor of a tropical disease product that entitles such
sponsor, or a person described under subsection (b)(2), to
priority review of a new drug application submitted under
section 505(b)(1) after the date of approval of the tropical
disease product.
``(7) Tropical disease product.--The term `tropical disease
product' means a product that--
``(A) is a new drug, antibiotic drug, biological product,
vaccine, device, diagnostic, or other tool for treatment of a
neglected or tropical disease; and
``(B) is approved by the Secretary for use in the treatment
of a neglected or tropical disease.
``(b) Priority Review Voucher.--
``(1) In general.--The Secretary shall award a priority
review voucher to the sponsor of a tropical disease product
upon approval by the Secretary of such tropical disease
product.
``(2) Transferability.--The sponsor of a tropical disease
product that receives a priority review voucher under this
section may transfer (including by sale) the entitlement to
such voucher to a sponsor of a new drug for which an
application under section 505(b)(1) will be submitted after
the date of the approval of the tropical disease product.
``(3) Limitation.--A sponsor of a tropical disease product
may not receive a priority review voucher under this section
if the tropical disease product was approved by the Secretary
prior to the date of enactment of this section.
``(c) Priority Review User Fee.--
``(1) In general.--The Secretary shall establish a user fee
program under which a sponsor of a drug that is the subject
of a priority review voucher shall pay to the Secretary a fee
determined under paragraph (2). Such fee shall be in addition
to any fee required to be submitted by the sponsor under
chapter VII.
``(2) Fee amount.--The amount of the priority review user
fee shall be determined each fiscal year by the Secretary and
based on the anticipated costs to the Secretary of
implementing this section.
``(3) Annual fee setting.--The Secretary shall establish,
before the beginning of each fiscal year beginning after
September 30, 2007, for that fiscal year, the amount of the
priority review user fee.
``(4) Payment.--
``(A) In general.--The fee required by this subsection
shall be due upon the filing of the new drug application
under section 505(b)(1) for which the voucher is used.
``(B) Complete application.--An application described under
subparagraph (A) for which the sponsor requests the use of a
priority review voucher shall be considered incomplete if the
fee required by this subsection is not included in such
application.''.
______

SA 986. Ms. LANDRIEU submitted an amendment intended to be proposed
by her to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the end of the bill, add the following:

TITLE--DOMESTIC PET TURTLE MARKET ACCESS

SEC. __. SHORT TITLE.

This title may be cited as the ``Domestic Pet Turtle Market
Access Act of 2007''.

SEC. __. FINDINGS.

Congress makes the following findings:
(1) Pet turtles less than 10.2 centimeters in diameter have
been banned for sale in the United States by the Food and
Drug Administration since 1975 due to health concerns.
(2) The Food and Drug Administration does not ban the sale
of iguanas or other lizards, snakes, frogs, or other
amphibians or reptiles that are sold as pets in the United
States that also carry salmonella bacteria. The Food and Drug
Administration also does not require that these animals be
treated for salmonella bacteria before being sold as pets.
(3) The technology to treat turtles for salmonella, and
make them safe for sale, has greatly advanced since 1975.
Treatments exist that can nearly eradicate salmonella from
turtles, and individuals are more aware of the causes of
salmonella, how to treat salmonella poisoning, and the
seriousness associated with salmonella poisoning.
(4) University research has shown that these turtles can be
treated in such a way that they can be raised, shipped, and
distributed without having a recolonization of salmonella.
(5) University research has also shown that pet owners can
be equipped with a treatment regiment that allows the turtle
to be maintained safe from salmonella.
(6) The Food and Drug Administration should allow the sale
of turtles less than 10.2 centimeters in diameter as pets as
long as the sellers are required to use proven methods to
treat the turtles for salmonella and maintain a safe pet.

SEC. __. SALE OF BABY TURTLES.

(a) In General.--Notwithstanding any other provision of
law, the Food and Drug Administration shall not restrict the
sale by a turtle farmer or other commercial retail seller of
a turtle that is less than 10.2 centimeters in diameter as a
pet if--
(1) the turtle is raised, shipped, and sold using methods
that are proven to keep the turtle free of salmonella, using
salmonella safety standards that are comparable to such
standards relating to other animals, including reptiles and
amphibians, that are allowed for sale as pets, or animal
products that are allowed for sale as food products;
(2) the Administration has approved a plan submitted by the
turtle farmer or commercial retail seller involved relating
to compliance with paragraph (1); and
(3) the farmer or other commercial retail seller includes,
with the sale of such a turtle, a disclosure to the buyer
that includes--
(A) information regarding--
(i) the dangers, including possible severe illness or
death, especially for at-risk people who may be susceptible
to salmonella poisoning, such as children, pregnant women,
and others who may have weak immune systems, that could
result if the turtle is not properly handled and safely
maintained;
(ii) the proper handling of the turtle, including an
explanation of proper hygiene such as handwashing after
handling a turtle; and
(iii) the proven methods of treatment that, if properly
applied, keep the turtle safe from salmonella;
(B) a detailed explanation of how to properly treat the
turtle to keep it safe from salmonella, using the proven
methods of treatment referred to under subparagraph (A), and
how the buyer can continue to purchase the tools, treatments,
or any other required item to continually treat the turtle;
and
(C) a statement that buyers of pet turtles should not
abandon the turtle or abandon it outside, as the turtle may
become an invasive species to the local community, but should
instead return them to a commercial retail pet seller or
other organization that would accept turtles no longer wanted
as pets.
(b) Plan.--
(1) In general.--A turtle farmer or other commercial seller
that desires to sell a turtle as provided for under
subsection (a) shall submit a plan to the Food and Drug
Administration that details the manner in which the farmer or
seller will ensure compliance with the requirements of
subsection (a)(1) with respect to the turtles involved. The
plan shall include use of non-antibiotic compounds that
suppress or eliminate the presence of salmonella in turtle
hatchlings.
(2) Action by fda.--Not later 30 days after the date on
which the Food and Drug Administration receives a plan under
paragraph (1), the Administration shall accept or reject such
plan. If such plan is rejected, the Administration shall
provide clear, specific guidance on the reasons for such
rejection. The Administration may only reject such a plan if
it is determined that the plan fails to achieve the same
salmonella safety standards as such standards relating to
other animals, including reptiles and amphibians, that are
allowed for sale as pets, or animal products that are allowed
for sale as food products.
(c) Rule of Construction.--Nothing in this section shall be
construed to permit the Food and Drug Administration to hold
the sale of turtles less than 10.2 centimeters in

[[Page S5408]]

diameter as a pet to any greater salmonella safety standard
applicable to other reptiles or amphibians sold as pets,
animals sold as pets, or food products regulated by such
Administration.
______

SA 987. Mr. INHOFE submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. HEAD START ACT AMENDMENT IMPOSING PARENTAL CONSENT
REQUIREMENT FOR NONEMERGENCY INTRUSIVE PHYSICAL
EXAMINATIONS.

The Head Start Act (42 U.S.C. 9831 et seq.) is amended by
adding at the end the following:

``SEC. 657A. PARENTAL CONSENT REQUIREMENT FOR NONEMERGENCY
INTRUSIVE PHYSICAL EXAMINATIONS.

``(a) In General.--A Head Start agency shall obtain written
parental consent before administration of any nonemergency
intrusive physical examination of a child in connection with
participation in a program under this subchapter.
``(b) Definition.--The term `nonemergency intrusive
physical examination' means, with respect to a child, a
physical examination that--
``(1) is not immediately necessary to protect the health or
safety of the child involved or the health or safety of
another individual; and
``(2) requires incision or is otherwise invasive, or
involves exposure of private body parts.''.
______

SA 988. Mr. INHOFE submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. CHILD MEDICATION SAFETY.

(a) Required Policies and Procedures.--
(1) In general.--As a condition of receiving funds under
any program or activity administered by the Secretary of
Education, not later than 1 year after the date of enactment
of this section, each State shall develop and implement
policies and procedures prohibiting school personnel from
requiring a child to obtain a prescription for substances
covered by section 202(c) of the Controlled Substances Act
(21 U.S.C. 812(c)) or a psychotropic drug as a condition of
attending school or receiving services.
(2) Rule of construction.--Nothing in paragraph (1) shall
be construed to create a Federal prohibition against teachers
and other school personnel consulting or sharing classroom-
based observations with parents or guardians regarding a
student's academic performance or behavior in the classroom
or school, or regarding the need for evaluation for special
education or related services under section 612(a)(3) of the
Individuals with Disabilities Education Act (20 U.S.C.
1412(a)(3)).
(3) Prohibition of payment of funds.--No Federal education
funds may be paid to any local educational agency or other
instrument of government that uses the refusal of a parent or
legal guardian to provide a substance covered by section
202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) or
a psychotropic drug for such individual's child as the basis
of a charge of child abuse, child neglect, education neglect,
or medical neglect until the agency or instrument
demonstrates that it is no longer using such refusal as a
basis of a child abuse, child neglect, education neglect, or
medical neglect charge.
(b) Definitions.--In this section:
(1) Child.--The term ``child'' means any person within the
age limits for which the State provides free public
education.
(2) Psychotropic drug.--The term ``psychotropic drug''
means a drug subject to section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) that is not a
substance covered by section 202(c) of the Controlled
Substances Act (21 U.S.C. 812(c)) but is--
(A) used in the diagnosis, treatment, or prevention of a
disease; and
(B) intended to have an altering effect on perception,
emotion, or behavior.
(3) State.--The term ``State'' means each of the 50 States,
the District of Columbia, and the Commonwealth of Puerto
Rico.
(c) GAO Study and Review.--
(1) Review.--The Comptroller General of the United States
shall conduct a review of--
(A) the variation among States in definitions of
psychotropic medications as used in regard to State
jurisdiction over public education;
(B) the prescription rates of medications used in public
schools to treat children diagnosed with attention deficit
disorder, attention deficit hyperactivity disorder, and other
disorders or illnesses;
(C) which medications used to treat such children in public
schools are listed under the Controlled Substances Act; and
(D) which medications used to treat such children in public
schools are not listed under the Controlled Substances Act,
including the properties and effects of any such medications,
including the incidence of hallucinations, psychosis,
violence, suicide, heart problems, significant weight gain,
or diabetes that students may experience while on these
medications.
(2) Report.--Not later than 1 year after the date of
enactment of this section, the Comptroller General of the
United States shall prepare and submit a report that contains
the results of the review under paragraph (1).
______

SA 989. Mr. HARKIN submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. REQUIRED INFORMATION IN DIRECT-TO-CONSUMER
TELEVISION AND RADIO ADVERTISEMENTS.

Section 502(n) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352(n)) is amended by inserting after the first
sentence the following: ``In addition to the requirements
under the preceding sentence, in the case of an advertisement
of a prescription drug presented directly to consumers in
television or radio format that states the name of the drug
and its medical indications, unless the audio portion of such
advertisement includes a listing of all information in full
about adverse reactions, contraindications, and precautions
listed in the patient or professional labeling of the drug
approved under this Act.''.
______

SA 990. Mr. DORGAN (for himself, Ms. Snowe, Mr. Grassley, Mr. McCain,
Ms. Stabenow, Mr. Nelson of Florida, Mr. Pryor, Mr. Sanders, Mr.
Whitehouse, and Mrs. McCaskill) submitted an amendment intended to be
proposed by him to the bill S. 1082, to amend the Federal Food, Drug,
and Cosmetic Act to reauthorize and amend the prescription drug user
fee provisions, and for other purposes; as follows:

At the appropriate place, insert the following:

TITLE __--IMPORTATION OF PRESCRIPTION DRUGS

SEC. _01. SHORT TITLE.

This title may be cited as the ``Pharmaceutical Market
Access and Drug Safety Act of 2007''.

SEC. _02. FINDINGS.

Congress finds that--
(1) Americans unjustly pay up to 5 times more to fill their
prescriptions than consumers in other countries;
(2) the United States is the largest market for
pharmaceuticals in the world, yet American consumers pay the
highest prices for brand pharmaceuticals in the world;
(3) a prescription drug is neither safe nor effective to an
individual who cannot afford it;
(4) allowing and structuring the importation of
prescription drugs to ensure access to safe and affordable
drugs approved by the Food and Drug Administration will
provide a level of safety to American consumers that they do
not currently enjoy;
(5) American spend more than $200,000,000,000 on
prescription drugs every year;
(6) the Congressional Budget Office has found that the cost
of prescription drugs are between 35 to 55 percent less in
other highly-developed countries than in the United States;
and
(7) promoting competitive market pricing would both
contribute to health care savings and allow greater access to
therapy, improving health and saving lives.

SEC. _03. REPEAL OF CERTAIN SECTION REGARDING IMPORTATION OF
PRESCRIPTION DRUGS.

Chapter VIII of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381 et seq.) is amended by striking section 804.

SEC. _04. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER OF
CERTAIN IMPORT RESTRICTIONS.

(a) In General.--Chapter VIII of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by
section _03, is further amended by inserting after section
803 the following:

``SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF
PRESCRIPTION DRUGS.

``(a) Importation of Prescription Drugs.--
``(1) In general.--In the case of qualifying drugs imported
or offered for import into the United States from registered
exporters or by registered importers--
``(A) the limitation on importation that is established in
section 801(d)(1) is waived; and
``(B) the standards referred to in section 801(a) regarding
admission of the drugs are subject to subsection (g) of this
section (including with respect to qualifying drugs to which
section 801(d)(1) does not apply).
``(2) Importers.--A qualifying drug may not be imported
under paragraph (1) unless--
``(A) the drug is imported by a pharmacy, group of
pharmacies, or a wholesaler that is a registered importer; or
``(B) the drug is imported by an individual for personal
use or for the use of a family

[[Page S5409]]

member of the individual (not for resale) from a registered
exporter.
``(3) Rule of construction.--This section shall apply only
with respect to a drug that is imported or offered for import
into the United States--
``(A) by a registered importer; or
``(B) from a registered exporter to an individual.
``(4) Definitions.--
``(A) Registered exporter; registered importer.--For
purposes of this section:
``(i) The term `registered exporter' means an exporter for
which a registration under subsection (b) has been approved
and is in effect.
``(ii) The term `registered importer' means a pharmacy,
group of pharmacies, or a wholesaler for which a registration
under subsection (b) has been approved and is in effect.
``(iii) The term `registration condition' means a condition
that must exist for a registration under subsection (b) to be
approved.
``(B) Qualifying drug.--For purposes of this section, the
term `qualifying drug' means a drug for which there is a
corresponding U.S. label drug.
``(C) U.S. label drug.--For purposes of this section, the
term `U.S. label drug' means a prescription drug that--
``(i) with respect to a qualifying drug, has the same
active ingredient or ingredients, route of administration,
dosage form, and strength as the qualifying drug;
``(ii) with respect to the qualifying drug, is manufactured
by or for the person that manufactures the qualifying drug;
``(iii) is approved under section 505(c); and
``(iv) is not--

``(I) a controlled substance, as defined in section 102 of
the Controlled Substances Act (21 U.S.C. 802);
``(II) a biological product, as defined in section 351 of
the Public Health Service Act (42 U.S.C. 262), including--

``(aa) a therapeutic DNA plasmid product;
``(bb) a therapeutic synthetic peptide product;
``(cc) a monoclonal antibody product for in vivo use; and
``(dd) a therapeutic recombinant DNA-derived product;

``(III) an infused drug, including a peritoneal dialysis
solution;
``(IV) an injected drug;
``(V) a drug that is inhaled during surgery;
``(VI) a drug that is the listed drug referred to in 2 or
more abbreviated new drug applications under which the drug
is commercially marketed; or
``(VII) a sterile opthlamic drug intended for topical use
on or in the eye.

``(D) Other definitions.--For purposes of this section:
``(i)(I) The term `exporter' means a person that is in the
business of exporting a drug to individuals in the United
States from Canada or from a permitted country designated by
the Secretary under subclause (II), or that, pursuant to
submitting a registration under subsection (b), seeks to be
in such business.
``(II) The Secretary shall designate a permitted country
under subparagraph (E) (other than Canada) as a country from
which an exporter may export a drug to individuals in the
United States if the Secretary determines that--

``(aa) the country has statutory or regulatory standards
that are equivalent to the standards in the United States and
Canada with respect to--

``(AA) the training of pharmacists;
``(BB) the practice of pharmacy; and
``(CC) the protection of the privacy of personal medical
information; and

``(bb) the importation of drugs to individuals in the
United States from the country will not adversely affect
public health.

``(ii) The term `importer' means a pharmacy, a group of
pharmacies, or a wholesaler that is in the business of
importing a drug into the United States or that, pursuant to
submitting a registration under subsection (b), seeks to be
in such business.
``(iii) The term `pharmacist' means a person licensed by a
State to practice pharmacy, including the dispensing and
selling of prescription drugs.
``(iv) The term `pharmacy' means a person that--

``(I) is licensed by a State to engage in the business of
selling prescription drugs at retail; and
``(II) employs 1 or more pharmacists.

``(v) The term `prescription drug' means a drug that is
described in section 503(b)(1).
``(vi) The term `wholesaler'--

``(I) means a person licensed as a wholesaler or
distributor of prescription drugs in the United States under
section 503(e)(2)(A); and
``(II) does not include a person authorized to import drugs
under section 801(d)(1).

``(E) Permitted country.--The term `permitted country'
means--
``(i) Australia;
``(ii) Canada;
``(iii) a member country of the European Union, but does
not include a member country with respect to which--

``(I) the country's Annex to the Treaty of Accession to the
European Union 2003 includes a transitional measure for the
regulation of human pharmaceutical products that has not
expired; or
``(II) the Secretary determines that the requirements
described in subclauses (I) and (II) of clause (vii) will not
be met by the date on which such transitional measure for the
regulation of human pharmaceutical products expires;

``(iv) Japan;
``(v) New Zealand;
``(vi) Switzerland; and
``(vii) a country in which the Secretary determines the
following requirements are met:

``(I) The country has statutory or regulatory
requirements--

``(aa) that require the review of drugs for safety and
effectiveness by an entity of the government of the country;
``(bb) that authorize the approval of only those drugs that
have been determined to be safe and effective by experts
employed by or acting on behalf of such entity and qualified
by scientific training and experience to evaluate the safety
and effectiveness of drugs on the basis of adequate and well-
controlled investigations, including clinical investigations,
conducted by experts qualified by scientific training and
experience to evaluate the safety and effectiveness of drugs;
``(cc) that require the methods used in, and the facilities
and controls used for the manufacture, processing, and
packing of drugs in the country to be adequate to preserve
their identity, quality, purity, and strength;
``(dd) for the reporting of adverse reactions to drugs and
procedures to withdraw approval and remove drugs found not to
be safe or effective; and
``(ee) that require the labeling and promotion of drugs to
be in accordance with the approval of the drug.

``(II) The valid marketing authorization system in the
country is equivalent to the systems in the countries
described in clauses (i) through (vi).
``(III) The importation of drugs to the United States from
the country will not adversely affect public health.

``(b) Registration of Importers and Exporters.--
``(1) Registration of importers and exporters.--A
registration condition is that the importer or exporter
involved (referred to in this subsection as a `registrant')
submits to the Secretary a registration containing the
following:
``(A)(i) In the case of an exporter, the name of the
exporter and an identification of all places of business of
the exporter that relate to qualifying drugs, including each
warehouse or other facility owned or controlled by, or
operated for, the exporter.
``(ii) In the case of an importer, the name of the importer
and an identification of the places of business of the
importer at which the importer initially receives a
qualifying drug after importation (which shall not exceed 3
places of business except by permission of the Secretary).
``(B) Such information as the Secretary determines to be
necessary to demonstrate that the registrant is in compliance
with registration conditions under--
``(i) in the case of an importer, subsections (c), (d),
(e), (g), and (j) (relating to the sources of imported
qualifying drugs; the inspection of facilities of the
importer; the payment of fees; compliance with the standards
referred to in section 801(a); and maintenance of records and
samples); or
``(ii) in the case of an exporter, subsections (c), (d),
(f), (g), (h), (i), and (j) (relating to the sources of
exported qualifying drugs; the inspection of facilities of
the exporter and the marking of compliant shipments; the
payment of fees; and compliance with the standards referred
to in section 801(a); being licensed as a pharmacist;
conditions for individual importation; and maintenance of
records and samples).
``(C) An agreement by the registrant that the registrant
will not under subsection (a) import or export any drug that
is not a qualifying drug.
``(D) An agreement by the registrant to--
``(i) notify the Secretary of a recall or withdrawal of a
qualifying drug distributed in a permitted country that the
registrant has exported or imported, or intends to export or
import, to the United States under subsection (a);
``(ii) provide for the return to the registrant of such
drug; and
``(iii) cease, or not begin, the exportation or importation
of such drug unless the Secretary has notified the registrant
that exportation or importation of such drug may proceed.
``(E) An agreement by the registrant to ensure and monitor
compliance with each registration condition, to promptly
correct any noncompliance with such a condition, and to
promptly report to the Secretary any such noncompliance.
``(F) A plan describing the manner in which the registrant
will comply with the agreement under subparagraph (E).
``(G) An agreement by the registrant to enforce a contract
under subsection (c)(3)(B) against a party in the chain of
custody of a qualifying drug with respect to the authority of
the Secretary under clauses (ii) and (iii) of that
subsection.
``(H) An agreement by the registrant to notify the
Secretary not more than 30 days before the registrant intends
to make the change, of--
``(i) any change that the registrant intends to make
regarding information provided under subparagraph (A) or (B);
and
``(ii) any change that the registrant intends to make in
the compliance plan under subparagraph (F).
``(I) In the case of an exporter--
``(i) An agreement by the exporter that a qualifying drug
will not under subsection (a)

[[Page S5410]]

be exported to any individual not authorized pursuant to
subsection (a)(2)(B) to be an importer of such drug.
``(ii) An agreement to post a bond, payable to the Treasury
of the United States that is equal in value to the lesser
of--

``(I) the value of drugs exported by the exporter to the
United States in a typical 4-week period over the course of a
year under this section; or
``(II) $1,000,000;

``(iii) An agreement by the exporter to comply with
applicable provisions of Canadian law, or the law of the
permitted country designated under subsection
(a)(4)(D)(i)(II) in which the exporter is located, that
protect the privacy of personal information with respect to
each individual importing a prescription drug from the
exporter under subsection (a)(2)(B).
``(iv) An agreement by the exporter to report to the
Secretary--

``(I) not later than August 1 of each fiscal year, the
total price and the total volume of drugs exported to the
United States by the exporter during the 6-month period from
January 1 through June 30 of that year; and
``(II) not later than January 1 of each fiscal year, the
total price and the total volume of drugs exported to the
United States by the exporter during the previous fiscal
year.

``(J) In the case of an importer, an agreement by the
importer to report to the Secretary--
``(i) not later than August 1 of each fiscal year, the
total price and the total volume of drugs imported to the
United States by the importer during the 6-month period from
January 1 through June 30 of that fiscal year; and
``(ii) not later than January 1 of each fiscal year, the
total price and the total volume of drugs imported to the
United States by the importer during the previous fiscal
year.
``(K) Such other provisions as the Secretary may require by
regulation to protect the public health while permitting--
``(i) the importation by pharmacies, groups of pharmacies,
and wholesalers as registered importers of qualifying drugs
under subsection (a); and
``(ii) importation by individuals of qualifying drugs under
subsection (a).
``(2) Approval or disapproval of registration.--
``(A) In general.--Not later than 90 days after the date on
which a registrant submits to the Secretary a registration
under paragraph (1), the Secretary shall notify the
registrant whether the registration is approved or is
disapproved. The Secretary shall disapprove a registration if
there is reason to believe that the registrant is not in
compliance with one or more registration conditions, and
shall notify the registrant of such reason. In the case of a
disapproved registration, the Secretary shall subsequently
notify the registrant that the registration is approved if
the Secretary determines that the registrant is in compliance
with such conditions.
``(B) Changes in registration information.--Not later than
30 days after receiving a notice under paragraph (1)(H) from
a registrant, the Secretary shall determine whether the
change involved affects the approval of the registration of
the registrant under paragraph (1), and shall inform the
registrant of the determination.
``(3) Publication of contact information for registered
exporters.--Through the Internet website of the Food and Drug
Administration and a toll-free telephone number, the
Secretary shall make readily available to the public a list
of registered exporters, including contact information for
the exporters. Promptly after the approval of a registration
submitted under paragraph (1), the Secretary shall update the
Internet website and the information provided through the
toll-free telephone number accordingly.
``(4) Suspension and termination.--
``(A) Suspension.--With respect to the effectiveness of a
registration submitted under paragraph (1):
``(i) Subject to clause (ii), the Secretary may suspend the
registration if the Secretary determines, after notice and
opportunity for a hearing, that the registrant has failed to
maintain substantial compliance with a registration
condition.
``(ii) If the Secretary determines that, under color of the
registration, the exporter has exported a drug or the
importer has imported a drug that is not a qualifying drug,
or a drug that does not comply with subsection (g)(2)(A) or
(g)(4), or has exported a qualifying drug to an individual in
violation of subsection (i)(2)(F), the Secretary shall
immediately suspend the registration. A suspension under the
preceding sentence is not subject to the provision by the
Secretary of prior notice, and the Secretary shall provide to
the registrant an opportunity for a hearing not later than 10
days after the date on which the registration is suspended.
``(iii) The Secretary may reinstate the registration,
whether suspended under clause (i) or (ii), if the Secretary
determines that the registrant has demonstrated that further
violations of registration conditions will not occur.
``(B) Termination.--The Secretary, after notice and
opportunity for a hearing, may terminate the registration
under paragraph (1) of a registrant if the Secretary
determines that the registrant has engaged in a pattern or
practice of violating 1 or more registration conditions, or
if on 1 or more occasions the Secretary has under
subparagraph (A)(ii) suspended the registration of the
registrant. The Secretary may make the termination permanent,
or for a fixed period of not less than 1 year. During the
period in which the registration is terminated, any
registration submitted under paragraph (1) by the registrant,
or a person that is a partner in the export or import
enterprise, or a principal officer in such enterprise, and
any registration prepared with the assistance of the
registrant or such a person, has no legal effect under this
section.
``(5) Default of bond.--A bond required to be posted by an
exporter under paragraph (1)(I)(ii) shall be defaulted and
paid to the Treasury of the United States if, after
opportunity for an informal hearing, the Secretary determines
that the exporter has--
``(A) exported a drug to the United States that is not a
qualifying drug or that is not in compliance with subsection
(g)(2)(A), (g)(4), or (i); or
``(B) failed to permit the Secretary to conduct an
inspection described under subsection (d).
``(c) Sources of Qualifying Drugs.--A registration
condition is that the exporter or importer involved agrees
that a qualifying drug will under subsection (a) be exported
or imported into the United States only if there is
compliance with the following:
``(1) The drug was manufactured in an establishment--
``(A) required to register under subsection (h) or (i) of
section 510; and
``(B)(i) inspected by the Secretary; or
``(ii) for which the Secretary has elected to rely on a
satisfactory report of a good manufacturing practice
inspection of the establishment from a permitted country
whose regulatory system the Secretary recognizes as
equivalent under a mutual recognition agreement, as provided
for under section 510(i)(3), section 803, or part 26 of title
21, Code of Federal Regulations (or any corresponding
successor rule or regulation).
``(2) The establishment is located in any country, and the
establishment manufactured the drug for distribution in the
United States or for distribution in 1 or more of the
permitted countries (without regard to whether in addition
the drug is manufactured for distribution in a foreign
country that is not a permitted country).
``(3) The exporter or importer obtained the drug--
``(A) directly from the establishment; or
``(B) directly from an entity that, by contract with the
exporter or importer--
``(i) provides to the exporter or importer a statement (in
such form and containing such information as the Secretary
may require) that, for the chain of custody from the
establishment, identifies each prior sale, purchase, or trade
of the drug (including the date of the transaction and the
names and addresses of all parties to the transaction);
``(ii) agrees to permit the Secretary to inspect such
statements and related records to determine their accuracy;
``(iii) agrees, with respect to the qualifying drugs
involved, to permit the Secretary to inspect warehouses and
other facilities, including records, of the entity for
purposes of determining whether the facilities are in
compliance with any standards under this Act that are
applicable to facilities of that type in the United States;
and
``(iv) has ensured, through such contractual relationships
as may be necessary, that the Secretary has the same
authority regarding other parties in the chain of custody
from the establishment that the Secretary has under clauses
(ii) and (iii) regarding such entity.
``(4)(A) The foreign country from which the importer will
import the drug is a permitted country; or
``(B) The foreign country from which the exporter will
export the drug is the permitted country in which the
exporter is located.
``(5) During any period in which the drug was not in the
control of the manufacturer of the drug, the drug did not
enter any country that is not a permitted country.
``(6) The exporter or importer retains a sample of each lot
of the drug for testing by the Secretary.
``(d) Inspection of Facilities; Marking of Shipments.--
``(1) Inspection of facilities.--A registration condition
is that, for the purpose of assisting the Secretary in
determining whether the exporter involved is in compliance
with all other registration conditions--
``(A) the exporter agrees to permit the Secretary--
``(i) to conduct onsite inspections, including monitoring
on a day-to-day basis, of places of business of the exporter
that relate to qualifying drugs, including each warehouse or
other facility owned or controlled by, or operated for, the
exporter;
``(ii) to have access, including on a day-to-day basis,
to--

``(I) records of the exporter that relate to the export of
such drugs, including financial records; and
``(II) samples of such drugs;

``(iii) to carry out the duties described in paragraph (3);
and
``(iv) to carry out any other functions determined by the
Secretary to be necessary regarding the compliance of the
exporter; and
``(B) the Secretary has assigned 1 or more employees of the
Secretary to carry out the functions described in this
subsection for the Secretary randomly, but not less than 12
times annually, on the premises of places of businesses
referred to in subparagraph (A)(i),

[[Page S5411]]

and such an assignment remains in effect on a continuous
basis.
``(2) Marking of compliant shipments.--A registration
condition is that the exporter involved agrees to affix to
each shipping container of qualifying drugs exported under
subsection (a) such markings as the Secretary determines to
be necessary to identify the shipment as being in compliance
with all registration conditions. Markings under the
preceding sentence shall--
``(A) be designed to prevent affixation of the markings to
any shipping container that is not authorized to bear the
markings; and
``(B) include anticounterfeiting or track-and-trace
technologies, taking into account the economic and technical
feasibility of those technologies.
``(3) Certain duties relating to exporters.--Duties of the
Secretary with respect to an exporter include the following:
``(A) Inspecting, randomly, but not less than 12 times
annually, the places of business of the exporter at which
qualifying drugs are stored and from which qualifying drugs
are shipped.
``(B) During the inspections under subparagraph (A),
verifying the chain of custody of a statistically significant
sample of qualifying drugs from the establishment in which
the drug was manufactured to the exporter, which shall be
accomplished or supplemented by the use of anticounterfeiting
or track-and-trace technologies, taking into account the
economic and technical feasibility of those technologies,
except that a drug that lacks such technologies from the
point of manufacture shall not for that reason be excluded
from importation by an exporter.
``(C) Randomly reviewing records of exports to individuals
for the purpose of determining whether the drugs are being
imported by the individuals in accordance with the conditions
under subsection (i). Such reviews shall be conducted in a
manner that will result in a statistically significant
determination of compliance with all such conditions.
``(D) Monitoring the affixing of markings under paragraph
(2).
``(E) Inspecting as the Secretary determines is necessary
the warehouses and other facilities, including records, of
other parties in the chain of custody of qualifying drugs.
``(F) Determining whether the exporter is in compliance
with all other registration conditions.
``(4) Prior notice of shipments.--A registration condition
is that, not less than 8 hours and not more than 5 days in
advance of the time of the importation of a shipment of
qualifying drugs, the importer involved agrees to submit to
the Secretary a notice with respect to the shipment of drugs
to be imported or offered for import into the United States
under subsection (a). A notice under the preceding sentence
shall include--
``(A) the name and complete contact information of the
person submitting the notice;
``(B) the name and complete contact information of the
importer involved;
``(C) the identity of the drug, including the established
name of the drug, the quantity of the drug, and the lot
number assigned by the manufacturer;
``(D) the identity of the manufacturer of the drug,
including the identity of the establishment at which the drug
was manufactured;
``(E) the country from which the drug is shipped;
``(F) the name and complete contact information for the
shipper of the drug;
``(G) anticipated arrival information, including the port
of arrival and crossing location within that port, and the
date and time;
``(H) a summary of the chain of custody of the drug from
the establishment in which the drug was manufactured to the
importer;
``(I) a declaration as to whether the Secretary has ordered
that importation of the drug from the permitted country cease
under subsection (g)(2)(C) or (D); and
``(J) such other information as the Secretary may require
by regulation.
``(5) Marking of compliant shipments.--A registration
condition is that the importer involved agrees, before
wholesale distribution (as defined in section 503(e)) of a
qualifying drug that has been imported under subsection (a),
to affix to each container of such drug such markings or
other technology as the Secretary determines necessary to
identify the shipment as being in compliance with all
registration conditions, except that the markings or other
technology shall not be required on a drug that bears
comparable, compatible markings or technology from the
manufacturer of the drug. Markings or other technology under
the preceding sentence shall--
``(A) be designed to prevent affixation of the markings or
other technology to any container that is not authorized to
bear the markings; and
``(B) shall include anticounterfeiting or track-and-trace
technologies, taking into account the economic and technical
feasibility of such technologies.
``(6) Certain duties relating to importers.--Duties of the
Secretary with respect to an importer include the following:
``(A) Inspecting, randomly, but not less than 12 times
annually, the places of business of the importer at which a
qualifying drug is initially received after importation.
``(B) During the inspections under subparagraph (A),
verifying the chain of custody of a statistically significant
sample of qualifying drugs from the establishment in which
the drug was manufactured to the importer, which shall be
accomplished or supplemented by the use of anticounterfeiting
or track-and-trace technologies, taking into account the
economic and technical feasibility of those technologies,
except that a drug that lacks such technologies from the
point of manufacture shall not for that reason be excluded
from importation by an importer.
``(C) Reviewing notices under paragraph (4).
``(D) Inspecting as the Secretary determines is necessary
the warehouses and other facilities, including records of
other parties in the chain of custody of qualifying drugs.
``(E) Determining whether the importer is in compliance
with all other registration conditions.
``(e) Importer Fees.--
``(1) Registration fee.--A registration condition is that
the importer involved pays to the Secretary a fee of $10,000
due on the date on which the importer first submits the
registration to the Secretary under subsection (b).
``(2) Inspection fee.--A registration condition is that the
importer involved pays a fee to the Secretary in accordance
with this subsection. Such fee shall be paid not later than
October 1 and April 1 of each fiscal year in the amount
provided for under paragraph (3).
``(3) Amount of inspection fee.--
``(A) Aggregate total of fees.--Not later than 30 days
before the start of each fiscal year, the Secretary, in
consultation with the Secretary of Homeland Security and the
Secretary of the Treasury, shall establish an aggregate total
of fees to be collected under paragraph (2) for importers for
that fiscal year that is sufficient, and not more than
necessary, to pay the costs for that fiscal year of
administering this section with respect to registered
importers, including the costs associated with--
``(i) inspecting the facilities of registered importers,
and of other entities in the chain of custody of a qualifying
drug as necessary, under subsection (d)(6);
``(ii) developing, implementing, and operating under such
subsection an electronic system for submission and review of
the notices required under subsection (d)(4) with respect to
shipments of qualifying drugs under subsection (a) to assess
compliance with all registration conditions when such
shipments are offered for import into the United States; and
``(iii) inspecting such shipments as necessary, when
offered for import into the United States to determine if
such a shipment should be refused admission under subsection
(g)(5).
``(B) Limitation.--Subject to subparagraph (C), the
aggregate total of fees collected under paragraph (2) for a
fiscal year shall not exceed 2.5 percent of the total price
of qualifying drugs imported during that fiscal year into the
United States by registered importers under subsection (a).
``(C) Total price of drugs.--
``(i) Estimate.--For the purposes of complying with the
limitation described in subparagraph (B) when establishing
under subparagraph (A) the aggregate total of fees to be
collected under paragraph (2) for a fiscal year, the
Secretary shall estimate the total price of qualifying drugs
imported into the United States by registered importers
during that fiscal year by adding the total price of
qualifying drugs imported by each registered importer during
the 6-month period from January 1 through June 30 of the
previous fiscal year, as reported to the Secretary by each
registered importer under subsection (b)(1)(J).
``(ii) Calculation.--Not later than March 1 of the fiscal
year that follows the fiscal year for which the estimate
under clause (i) is made, the Secretary shall calculate the
total price of qualifying drugs imported into the United
States by registered importers during that fiscal year by
adding the total price of qualifying drugs imported by each
registered importer during that fiscal year, as reported to
the Secretary by each registered importer under subsection
(b)(1)(J).
``(iii) Adjustment.--If the total price of qualifying drugs
imported into the United States by registered importers
during a fiscal year as calculated under clause (ii) is less
than the aggregate total of fees collected under paragraph
(2) for that fiscal year, the Secretary shall provide for a
pro-rata reduction in the fee due from each registered
importer on April 1 of the subsequent fiscal year so that the
limitation described in subparagraph (B) is observed.
``(D) Individual importer fee.--Subject to the limitation
described in subparagraph (B), the fee under paragraph (2) to
be paid on October 1 and April 1 by an importer shall be an
amount that is proportional to a reasonable estimate by the
Secretary of the semiannual share of the importer of the
volume of qualifying drugs imported by importers under
subsection (a).
``(4) Use of fees.--
``(A) In general.--Subject to appropriations Acts, fees
collected by the Secretary under paragraphs (1) and (2) shall
be credited to the appropriation account for salaries and
expenses of the Food and Drug Administration until expended
(without fiscal year limitation), and the Secretary may, in
consultation with the Secretary of Homeland Security and the
Secretary of the Treasury, transfer some proportion of such
fees to the appropriation account for salaries and expenses
of the Bureau of Customs and Border Protection until expended
(without fiscal year limitation).
``(B) Sole purpose.--Fees collected by the Secretary under
paragraphs (1) and (2) are

[[Page S5412]]

only available to the Secretary and, if transferred, to the
Secretary of Homeland Security, and are for the sole purpose
of paying the costs referred to in paragraph (3)(A).
``(5) Collection of fees.--In any case where the Secretary
does not receive payment of a fee assessed under paragraph
(1) or (2) within 30 days after it is due, such fee shall be
treated as a claim of the United States Government subject to
subchapter II of chapter 37 of title 31, United States Code.
``(f) Exporter Fees.--
``(1) Registration fee.--A registration condition is that
the exporter involved pays to the Secretary a fee of $10,000
due on the date on which the exporter first submits that
registration to the Secretary under subsection (b).
``(2) Inspection fee.--A registration condition is that the
exporter involved pays a fee to the Secretary in accordance
with this subsection. Such fee shall be paid not later than
October 1 and April 1 of each fiscal year in the amount
provided for under paragraph (3).
``(3) Amount of inspection fee.--
``(A) Aggregate total of fees.--Not later than 30 days
before the start of each fiscal year, the Secretary, in
consultation with the Secretary of Homeland Security and the
Secretary of the Treasury, shall establish an aggregate total
of fees to be collected under paragraph (2) for exporters for
that fiscal year that is sufficient, and not more than
necessary, to pay the costs for that fiscal year of
administering this section with respect to registered
exporters, including the costs associated with--
``(i) inspecting the facilities of registered exporters,
and of other entities in the chain of custody of a qualifying
drug as necessary, under subsection (d)(3);
``(ii) developing, implementing, and operating under such
subsection a system to screen marks on shipments of
qualifying drugs under subsection (a) that indicate
compliance with all registration conditions, when such
shipments are offered for import into the United States; and
``(iii) screening such markings, and inspecting such
shipments as necessary, when offered for import into the
United States to determine if such a shipment should be
refused admission under subsection (g)(5).
``(B) Limitation.--Subject to subparagraph (C), the
aggregate total of fees collected under paragraph (2) for a
fiscal year shall not exceed 2.5 percent of the total price
of qualifying drugs imported during that fiscal year into the
United States by registered exporters under subsection (a).
``(C) Total price of drugs.--
``(i) Estimate.--For the purposes of complying with the
limitation described in subparagraph (B) when establishing
under subparagraph (A) the aggregate total of fees to be
collected under paragraph (2) for a fiscal year, the
Secretary shall estimate the total price of qualifying drugs
imported into the United States by registered exporters
during that fiscal year by adding the total price of
qualifying drugs exported by each registered exporter during
the 6-month period from January 1 through June 30 of the
previous fiscal year, as reported to the Secretary by each
registered exporter under subsection (b)(1)(I)(iv).
``(ii) Calculation.--Not later than March 1 of the fiscal
year that follows the fiscal year for which the estimate
under clause (i) is made, the Secretary shall calculate the
total price of qualifying drugs imported into the United
States by registered exporters during that fiscal year by
adding the total price of qualifying drugs exported by each
registered exporter during that fiscal year, as reported to
the Secretary by each registered exporter under subsection
(b)(1)(I)(iv).
``(iii) Adjustment.--If the total price of qualifying drugs
imported into the United States by registered exporters
during a fiscal year as calculated under clause (ii) is less
than the aggregate total of fees collected under paragraph
(2) for that fiscal year, the Secretary shall provide for a
pro-rata reduction in the fee due from each registered
exporter on April 1 of the subsequent fiscal year so that the
limitation described in subparagraph (B) is observed.
``(D) Individual exporter fee.--Subject to the limitation
described in subparagraph (B), the fee under paragraph (2) to
be paid on October 1 and April 1 by an exporter shall be an
amount that is proportional to a reasonable estimate by the
Secretary of the semiannual share of the exporter of the
volume of qualifying drugs exported by exporters under
subsection (a).
``(4) Use of fees.--
``(A) In general.--Subject to appropriations Acts, fees
collected by the Secretary under paragraphs (1) and (2) shall
be credited to the appropriation account for salaries and
expenses of the Food and Drug Administration until expended
(without fiscal year limitation), and the Secretary may, in
consultation with the Secretary of Homeland Security and the
Secretary of the Treasury, transfer some proportion of such
fees to the appropriation account for salaries and expenses
of the Bureau of Customs and Border Protection until expended
(without fiscal year limitation).
``(B) Sole purpose.--Fees collected by the Secretary under
paragraphs (1) and (2) are only available to the Secretary
and, if transferred, to the Secretary of Homeland Security,
and are for the sole purpose of paying the costs referred to
in paragraph (3)(A).
``(5) Collection of fees.--In any case where the Secretary
does not receive payment of a fee assessed under paragraph
(1) or (2) within 30 days after it is due, such fee shall be
treated as a claim of the United States Government subject to
subchapter II of chapter 37 of title 31, United States Code.
``(g) Compliance With Section 801(a).--
``(1) In general.--A registration condition is that each
qualifying drug exported under subsection (a) by the
registered exporter involved or imported under subsection (a)
by the registered importer involved is in compliance with the
standards referred to in section 801(a) regarding admission
of the drug into the United States, subject to paragraphs
(2), (3), and (4).
``(2) Section 505; approval status.--
``(A) In general.--A qualifying drug that is imported or
offered for import under subsection (a) shall comply with the
conditions established in the approved application under
section 505(b) for the U.S. label drug as described under
this subsection.
``(B) Notice by manufacturer; general provisions.--
``(i) In general.--The person that manufactures a
qualifying drug that is, or will be, introduced for
commercial distribution in a permitted country shall in
accordance with this paragraph submit to the Secretary a
notice that--

``(I) includes each difference in the qualifying drug from
a condition established in the approved application for the
U.S. label drug beyond--

``(aa) the variations provided for in the application; and
``(bb) any difference in labeling (except ingredient
labeling); or

``(II) states that there is no difference in the qualifying
drug from a condition established in the approved application
for the U.S. label drug beyond--

``(aa) the variations provided for in the application; and
``(bb) any difference in labeling (except ingredient
labeling).
``(ii) Information in notice.--A notice under clause (i)(I)
shall include the information that the Secretary may require
under section 506A, any additional information the Secretary
may require (which may include data on bioequivalence if such
data are not required under section 506A), and, with respect
to the permitted country that approved the qualifying drug
for commercial distribution, or with respect to which such
approval is sought, include the following:

``(I) The date on which the qualifying drug with such
difference was, or will be, introduced for commercial
distribution in the permitted country.
``(II) Information demonstrating that the person submitting
the notice has also notified the government of the permitted
country in writing that the person is submitting to the
Secretary a notice under clause (i)(I), which notice
describes the difference in the qualifying drug from a
condition established in the approved application for the
U.S. label drug.
``(III) The information that the person submitted or will
submit to the government of the permitted country for
purposes of obtaining approval for commercial distribution of
the drug in the country which, if in a language other than
English, shall be accompanied by an English translation
verified to be complete and accurate, with the name, address,
and a brief statement of the qualifications of the person
that made the translation.

``(iii) Certifications.--The chief executive officer and
the chief medical officer of the manufacturer involved shall
each certify in the notice under clause (i) that--

``(I) the information provided in the notice is complete
and true; and
``(II) a copy of the notice has been provided to the
Federal Trade Commission and to the State attorneys general.

``(iv) Fee.--If a notice submitted under clause (i)
includes a difference that would, under section 506A, require
the submission of a supplemental application if made as a
change to the U.S. label drug, the person that submits the
notice shall pay to the Secretary a fee in the same amount as
would apply if the person were paying a fee pursuant to
section 736(a)(1)(A)(ii). Subject to appropriations Acts,
fees collected by the Secretary under the preceding sentence
are available only to the Secretary and are for the sole
purpose of paying the costs of reviewing notices submitted
under clause (i).
``(v) Timing of submission of notices.--

``(I) Prior approval notices.--A notice under clause (i) to
which subparagraph (C) applies shall be submitted to the
Secretary not later than 120 days before the qualifying drug
with the difference is introduced for commercial distribution
in a permitted country, unless the country requires that
distribution of the qualifying drug with the difference begin
less than 120 days after the country requires the difference.
``(II) Other approval notices.--A notice under clause (i)
to which subparagraph (D) applies shall be submitted to the
Secretary not later than the day on which the qualifying drug
with the difference is introduced for commercial distribution
in a permitted country.
``(III) Other notices.--A notice under clause (i) to which
subparagraph (E) applies shall be submitted to the Secretary
on the date that the qualifying drug is first introduced for
commercial distribution in a permitted country and annually
thereafter.

``(vi) Review by secretary.--

``(I) In general.--In this paragraph, the difference in a
qualifying drug that is submitted in a notice under clause
(i) from the

[[Page S5413]]

U.S. label drug shall be treated by the Secretary as if it
were a manufacturing change to the U.S. label drug under
section 506A.
``(II) Standard of review.--Except as provided in subclause
(III), the Secretary shall review and approve or disapprove
the difference in a notice submitted under clause (i), if
required under section 506A, using the safe and effective
standard for approving or disapproving a manufacturing change
under section 506A.
``(III) Bioequivalence.--If the Secretary would approve the
difference in a notice submitted under clause (i) using the
safe and effective standard under section 506A and if the
Secretary determines that the qualifying drug is not
bioequivalent to the U.S. label drug, the Secretary shall--

``(aa) include in the labeling provided under paragraph (3)
a prominent advisory that the qualifying drug is safe and
effective but is not bioequivalent to the U.S. label drug if
the Secretary determines that such an advisory is necessary
for health care practitioners and patients to use the
qualifying drug safely and effectively; or
``(bb) decline to approve the difference if the Secretary
determines that the availability of both the qualifying drug
and the U.S. label drug would pose a threat to the public
health.

``(IV) Review by the secretary.--The Secretary shall review
and approve or disapprove the difference in a notice
submitted under clause (i), if required under section 506A,
not later than 120 days after the date on which the notice is
submitted.
``(V) Establishment inspection.--If review of such
difference would require an inspection of the establishment
in which the qualifying drug is manufactured--

``(aa) such inspection by the Secretary shall be
authorized; and
``(bb) the Secretary may rely on a satisfactory report of a
good manufacturing practice inspection of the establishment
from a permitted country whose regulatory system the
Secretary recognizes as equivalent under a mutual recognition
agreement, as provided under section 510(i)(3), section 803,
or part 26 of title 21, Code of Federal Regulations (or any
corresponding successor rule or regulation).
``(vii) Publication of information on notices.--

``(I) In general.--Through the Internet website of the Food
and Drug Administration and a toll-free telephone number, the
Secretary shall readily make available to the public a list
of notices submitted under clause (i).
``(II) Contents.--The list under subclause (I) shall
include the date on which a notice is submitted and whether--

``(aa) a notice is under review;
``(bb) the Secretary has ordered that importation of the
qualifying drug from a permitted country cease; or
``(cc) the importation of the drug is permitted under
subsection (a).

``(III) Update.--The Secretary shall promptly update the
Internet website with any changes to the list.

``(C) Notice; drug difference requiring prior approval.--In
the case of a notice under subparagraph (B)(i) that includes
a difference that would, under section 506A(c) or
(d)(3)(B)(i), require the approval of a supplemental
application before the difference could be made to the U.S.
label drug the following shall occur:
``(i) Promptly after the notice is submitted, the Secretary
shall notify registered exporters, registered importers, the
Federal Trade Commission, and the State attorneys general
that the notice has been submitted with respect to the
qualifying drug involved.
``(ii) If the Secretary has not made a determination
whether such a supplemental application regarding the U.S.
label drug would be approved or disapproved by the date on
which the qualifying drug involved is to be introduced for
commercial distribution in a permitted country, the Secretary
shall--

``(I) order that the importation of the qualifying drug
involved from the permitted country not begin until the
Secretary completes review of the notice; and
``(II) promptly notify registered exporters, registered
importers, the Federal Trade Commission, and the State
attorneys general of the order.

``(iii) If the Secretary determines that such a
supplemental application regarding the U.S. label drug would
not be approved, the Secretary shall--

``(I) order that the importation of the qualifying drug
involved from the permitted country cease, or provide that an
order under clause (ii), if any, remains in effect;
``(II) notify the permitted country that approved the
qualifying drug for commercial distribution of the
determination; and
``(III) promptly notify registered exporters, registered
importers, the Federal Trade Commission, and the State
attorneys general of the determination.

``(iv) If the Secretary determines that such a supplemental
application regarding the U.S. label drug would be approved,
the Secretary shall--

``(I) vacate the order under clause (ii), if any;
``(II) consider the difference to be a variation provided
for in the approved application for the U.S. label drug;
``(III) permit importation of the qualifying drug under
subsection (a); and
``(IV) promptly notify registered exporters, registered
importers, the Federal Trade Commission, and the State
attorneys general of the determination.

``(D) Notice; drug difference not requiring prior
approval.--In the case of a notice under subparagraph (B)(i)
that includes a difference that would, under section
506A(d)(3)(B)(ii), not require the approval of a supplemental
application before the difference could be made to the U.S.
label drug the following shall occur:
``(i) During the period in which the notice is being
reviewed by the Secretary, the authority under this
subsection to import the qualifying drug involved continues
in effect.
``(ii) If the Secretary determines that such a supplemental
application regarding the U.S. label drug would not be
approved, the Secretary shall--

``(I) order that the importation of the qualifying drug
involved from the permitted country cease;
``(II) notify the permitted country that approved the
qualifying drug for commercial distribution of the
determination; and
``(III) promptly notify registered exporters, registered
importers, the Federal Trade Commission, and the State
attorneys general of the determination.

``(iii) If the Secretary determines that such a
supplemental application regarding the U.S. label drug would
be approved, the difference shall be considered to be a
variation provided for in the approved application for the
U.S. label drug.
``(E) Notice; drug difference not requiring approval; no
difference.--In the case of a notice under subparagraph
(B)(i) that includes a difference for which, under section
506A(d)(1)(A), a supplemental application would not be
required for the difference to be made to the U.S. label
drug, or that states that there is no difference, the
Secretary--
``(i) shall consider such difference to be a variation
provided for in the approved application for the U.S. label
drug;
``(ii) may not order that the importation of the qualifying
drug involved cease; and
``(iii) shall promptly notify registered exporters and
registered importers.
``(F) Differences in active ingredient, route of
administration, dosage form, or strength.--
``(i) In general.--A person who manufactures a drug
approved under section 505(b) shall submit an application
under section 505(b) for approval of another drug that is
manufactured for distribution in a permitted country by or
for the person that manufactures the drug approved under
section 505(b) if--

``(I) there is no qualifying drug in commercial
distribution in permitted countries whose combined population
represents at least 50 percent of the total population of all
permitted countries with the same active ingredient or
ingredients, route of administration, dosage form, and
strength as the drug approved under section 505(b); and
``(II) each active ingredient of the other drug is related
to an active ingredient of the drug approved under section
505(b), as defined in clause (v).

``(ii) Application under section 505(b).--The application
under section 505(b) required under clause (i) shall--

``(I) request approval of the other drug for the indication
or indications for which the drug approved under section
505(b) is labeled;
``(II) include the information that the person submitted to
the government of the permitted country for purposes of
obtaining approval for commercial distribution of the other
drug in that country, which if in a language other than
English, shall be accompanied by an English translation
verified to be complete and accurate, with the name, address,
and a brief statement of the qualifications of the person
that made the translation;
``(III) include a right of reference to the application for
the drug approved under section 505(b); and
``(IV) include such additional information as the Secretary
may require.

``(iii) Timing of submission of application.--An
application under section 505(b) required under clause (i)
shall be submitted to the Secretary not later than the day on
which the information referred to in clause (ii)(II) is
submitted to the government of the permitted country.
``(iv) Notice of decision on application.--The Secretary
shall promptly notify registered exporters, registered
importers, the Federal Trade Commission, and the State
attorneys general of a determination to approve or to
disapprove an application under section 505(b) required under
clause (i).
``(v) Related active ingredients.--For purposes of clause
(i)(II), 2 active ingredients are related if they are--

``(I) the same; or
``(II) different salts, esters, or complexes of the same
moiety.

``(3) Section 502; labeling.--
``(A) Importation by registered importer.--
``(i) In general.--In the case of a qualifying drug that is
imported or offered for import by a registered importer, such
drug shall be considered to be in compliance with section 502
and the labeling requirements under the approved application
for the U.S. label drug if the qualifying drug bears--

``(I) a copy of the labeling approved for the U.S. label
drug under section 505, without regard to whether the copy
bears any trademark involved;
``(II) the name of the manufacturer and location of the
manufacturer;
``(III) the lot number assigned by the manufacturer;

[[Page S5414]]

``(IV) the name, location, and registration number of the
importer; and
``(V) the National Drug Code number assigned to the
qualifying drug by the Secretary.

``(ii) Request for copy of the labeling.--The Secretary
shall provide such copy to the registered importer involved,
upon request of the importer.
``(iii) Requested labeling.--The labeling provided by the
Secretary under clause (ii) shall--

``(I) include the established name, as defined in section
502(e)(3), for each active ingredient in the qualifying drug;
``(II) not include the proprietary name of the U.S. label
drug or any active ingredient thereof;
``(III) if required under paragraph (2)(B)(vi)(III), a
prominent advisory that the qualifying drug is safe and
effective but not bioequivalent to the U.S. label drug; and
``(IV) if the inactive ingredients of the qualifying drug
are different from the inactive ingredients for the U.S.
label drug, include--

``(aa) a prominent notice that the ingredients of the
qualifying drug differ from the ingredients of the U.S. label
drug and that the qualifying drug must be dispensed with an
advisory to people with allergies about this difference and a
list of ingredients; and
``(bb) a list of the ingredients of the qualifying drug as
would be required under section 502(e).
``(B) Importation by individual.--
``(i) In general.--In the case of a qualifying drug that is
imported or offered for import by a registered exporter to an
individual, such drug shall be considered to be in compliance
with section 502 and the labeling requirements under the
approved application for the U.S. label drug if the packaging
and labeling of the qualifying drug complies with all
applicable regulations promulgated under sections 3 and 4 of
the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471
et seq.) and the labeling of the qualifying drug includes--

``(I) directions for use by the consumer;
``(II) the lot number assigned by the manufacturer;
``(III) the name and registration number of the exporter;
``(IV) if required under paragraph (2)(B)(vi)(III), a
prominent advisory that the drug is safe and effective but
not bioequivalent to the U.S. label drug;
``(V) if the inactive ingredients of the drug are different
from the inactive ingredients for the U.S. label drug--

``(aa) a prominent advisory that persons with an allergy
should check the ingredient list of the drug because the
ingredients of the drug differ from the ingredients of the
U.S. label drug; and
``(bb) a list of the ingredients of the drug as would be
required under section 502(e); and

``(VI) a copy of any special labeling that would be
required by the Secretary had the U.S. label drug been
dispensed by a pharmacist in the United States, without
regard to whether the special labeling bears any trademark
involved.

``(ii) Packaging.--A qualifying drug offered for import to
an individual by an exporter under this section that is
packaged in a unit-of-use container (as those items are
defined in the United States Pharmacopeia and National
Formulary) shall not be repackaged, provided that--

``(I) the packaging complies with all applicable
regulations under sections 3 and 4 of the Poison Prevention
Packaging Act of 1970 (15 U.S.C. 1471 et seq.); or
``(II) the consumer consents to waive the requirements of
such Act, after being informed that the packaging does not
comply with such Act and that the exporter will provide the
drug in packaging that is compliant at no additional cost.

``(iii) Request for copy of special labeling and ingredient
list.--The Secretary shall provide to the registered exporter
involved a copy of the special labeling, the advisory, and
the ingredient list described under clause (i), upon request
of the exporter.
``(iv) Requested labeling and ingredient list.--The
labeling and ingredient list provided by the Secretary under
clause (iii) shall--

``(I) include the established name, as defined in section
502(e)(3), for each active ingredient in the drug; and
``(II) not include the proprietary name of the U.S. label
drug or any active ingredient thereof.

``(4) Section 501; adulteration.--A qualifying drug that is
imported or offered for import under subsection (a) shall be
considered to be in compliance with section 501 if the drug
is in compliance with subsection (c).
``(5) Standards for refusing admission.--A drug exported
under subsection (a) from a registered exporter or imported
by a registered importer may be refused admission into the
United States if 1 or more of the following applies:
``(A) The drug is not a qualifying drug.
``(B) A notice for the drug required under paragraph (2)(B)
has not been submitted to the Secretary.
``(C) The Secretary has ordered that importation of the
drug from the permitted country cease under paragraph (2) (C)
or (D).
``(D) The drug does not comply with paragraph (3) or (4).
``(E) The shipping container appears damaged in a way that
may affect the strength, quality, or purity of the drug.
``(F) The Secretary becomes aware that--
``(i) the drug may be counterfeit;
``(ii) the drug may have been prepared, packed, or held
under insanitary conditions; or
``(iii) the methods used in, or the facilities or controls
used for, the manufacturing, processing, packing, or holding
of the drug do not conform to good manufacturing practice.
``(G) The Secretary has obtained an injunction under
section 302 that prohibits the distribution of the drug in
interstate commerce.
``(H) The Secretary has under section 505(e) withdrawn
approval of the drug.
``(I) The manufacturer of the drug has instituted a recall
of the drug.
``(J) If the drug is imported or offered for import by a
registered importer without submission of a notice in
accordance with subsection (d)(4).
``(K) If the drug is imported or offered for import from a
registered exporter to an individual and 1 or more of the
following applies:
``(i) The shipping container for such drug does not bear
the markings required under subsection (d)(2).
``(ii) The markings on the shipping container appear to be
counterfeit.
``(iii) The shipping container or markings appear to have
been tampered with.
``(h) Exporter Licensure in Permitted Country.--A
registration condition is that the exporter involved agrees
that a qualifying drug will be exported to an individual only
if the Secretary has verified that--
``(1) the exporter is authorized under the law of the
permitted country in which the exporter is located to
dispense prescription drugs; and
``(2) the exporter employs persons that are licensed under
the law of the permitted country in which the exporter is
located to dispense prescription drugs in sufficient number
to dispense safely the drugs exported by the exporter to
individuals, and the exporter assigns to those persons
responsibility for dispensing such drugs to individuals.
``(i) Individuals; Conditions for Importation.--
``(1) In general.--For purposes of subsection (a)(2)(B),
the importation of a qualifying drug by an individual is in
accordance with this subsection if the following conditions
are met:
``(A) The drug is accompanied by a copy of a prescription
for the drug, which prescription--
``(i) is valid under applicable Federal and State laws; and
``(ii) was issued by a practitioner who, under the law of a
State of which the individual is a resident, or in which the
individual receives care from the practitioner who issues the
prescription, is authorized to administer prescription drugs.
``(B) The drug is accompanied by a copy of the
documentation that was required under the law or regulations
of the permitted country in which the exporter is located, as
a condition of dispensing the drug to the individual.
``(C) The copies referred to in subparagraphs (A)(i) and
(B) are marked in a manner sufficient--
``(i) to indicate that the prescription, and the equivalent
document in the permitted country in which the exporter is
located, have been filled; and
``(ii) to prevent a duplicative filling by another
pharmacist.
``(D) The individual has provided to the registered
exporter a complete list of all drugs used by the individual
for review by the individuals who dispense the drug.
``(E) The quantity of the drug does not exceed a 90-day
supply.
``(F) The drug is not an ineligible subpart H drug. For
purposes of this section, a prescription drug is an
`ineligible subpart H drug' if the drug was approved by the
Secretary under subpart H of part 314 of title 21, Code of
Federal Regulations (relating to accelerated approval), with
restrictions under section 520 of such part to assure safe
use, and the Secretary has published in the Federal Register
a notice that the Secretary has determined that good cause
exists to prohibit the drug from being imported pursuant to
this subsection.
``(2) Notice regarding drug refused admission.--If a
registered exporter ships a drug to an individual pursuant to
subsection (a)(2)(B) and the drug is refused admission to the
United States, a written notice shall be sent to the
individual and to the exporter that informs the individual
and the exporter of such refusal and the reason for the
refusal.
``(j) Maintenance of Records and Samples.--
``(1) In general.--A registration condition is that the
importer or exporter involved shall--
``(A) maintain records required under this section for not
less than 2 years; and
``(B) maintain samples of each lot of a qualifying drug
required under this section for not more than 2 years.
``(2) Place of record maintenance.--The records described
under paragraph (1) shall be maintained--
``(A) in the case of an importer, at the place of business
of the importer at which the importer initially receives the
qualifying drug after importation; or
``(B) in the case of an exporter, at the facility from
which the exporter ships the qualifying drug to the United
States.
``(k) Drug Recalls.--
``(1) Manufacturers.--A person that manufactures a
qualifying drug imported from a

[[Page S5415]]

permitted country under this section shall promptly inform
the Secretary--
``(A) if the drug is recalled or withdrawn from the market
in a permitted country;
``(B) how the drug may be identified, including lot number;
and
``(C) the reason for the recall or withdrawal.
``(2) Secretary.--With respect to each permitted country,
the Secretary shall--
``(A) enter into an agreement with the government of the
country to receive information about recalls and withdrawals
of qualifying drugs in the country; or
``(B) monitor recalls and withdrawals of qualifying drugs
in the country using any information that is available to the
public in any media.
``(3) Notice.--The Secretary may notify, as appropriate,
registered exporters, registered importers, wholesalers,
pharmacies, or the public of a recall or withdrawal of a
qualifying drug in a permitted country.
``(l) Drug Labeling and Packaging.--
``(1) In general.--When a qualifying drug that is imported
into the United States by an importer under subsection (a) is
dispensed by a pharmacist to an individual, the pharmacist
shall provide that the packaging and labeling of the drug
complies with all applicable regulations promulgated under
sections 3 and 4 of the Poison Prevention Packaging Act of
1970 (15 U.S.C. 1471 et seq.) and shall include with any
other labeling provided to the individual the following:
``(A) The lot number assigned by the manufacturer.
``(B) The name and registration number of the importer.
``(C) If required under paragraph (2)(B)(vi)(III) of
subsection (g), a prominent advisory that the drug is safe
and effective but not bioequivalent to the U.S. label drug.
``(D) If the inactive ingredients of the drug are different
from the inactive ingredients for the U.S. label drug--
``(i) a prominent advisory that persons with allergies
should check the ingredient list of the drug because the
ingredients of the drug differ from the ingredients of the
U.S. label drug; and
``(ii) a list of the ingredients of the drug as would be
required under section 502(e).
``(2) Packaging.--A qualifying drug that is packaged in a
unit-of-use container (as those terms are defined in the
United States Pharmacopeia and National Formulary) shall not
be repackaged, provided that--
``(A) the packaging complies with all applicable
regulations under sections 3 and 4 of the Poison Prevention
Packaging Act of 1970 (15 U.S.C. 1471 et seq.); or
``(B) the consumer consents to waive the requirements of
such Act, after being informed that the packaging does not
comply with such Act and that the pharmacist will provide the
drug in packaging that is compliant at no additional cost.
``(m) Charitable Contributions.--Notwithstanding any other
provision of this section, this section does not authorize
the importation into the United States of a qualifying drug
donated or otherwise supplied for free or at nominal cost by
the manufacturer of the drug to a charitable or humanitarian
organization, including the United Nations and affiliates, or
to a government of a foreign country.
``(n) Unfair and Discriminatory Acts and Practices.--
``(1) In general.--It is unlawful for a manufacturer,
directly or indirectly (including by being a party to a
licensing agreement or other agreement), to--
``(A) discriminate by charging a higher price for a
prescription drug sold to a registered exporter or other
person in a permitted country that exports a qualifying drug
to the United States under this section than the price that
is charged, inclusive of rebates or other incentives to the
permitted country or other person, to another person that is
in the same country and that does not export a qualifying
drug into the United States under this section;
``(B) discriminate by charging a higher price for a
prescription drug sold to a registered importer or other
person that distributes, sells, or uses a qualifying drug
imported into the United States under this section than the
price that is charged to another person in the United States
that does not import a qualifying drug under this section, or
that does not distribute, sell, or use such a drug;
``(C) discriminate by denying, restricting, or delaying
supplies of a prescription drug to a registered exporter or
other person in a permitted country that exports a qualifying
drug to the United States under this section or to a
registered importer or other person that distributes, sells,
or uses a qualifying drug imported into the United States
under this section;
``(D) discriminate by publicly, privately, or otherwise
refusing to do business with a registered exporter or other
person in a permitted country that exports a qualifying drug
to the United States under this section or with a registered
importer or other person that distributes, sells, or uses a
qualifying drug imported into the United States under this
section;
``(E) knowingly fail to submit a notice under subsection
(g)(2)(B)(i), knowingly fail to submit such a notice on or
before the date specified in subsection (g)(2)(B)(v) or as
otherwise required under subsection (e) (3), (4), and (5) of
section 4 of the Pharmaceutical Market Access and Drug Safety
Act of 2007, knowingly submit such a notice that makes a
materially false, fictitious, or fraudulent statement, or
knowingly fail to provide promptly any information requested
by the Secretary to review such a notice;
``(F) knowingly fail to submit an application required
under subsection (g)(2)(F), knowingly fail to submit such an
application on or before the date specified in subsection
(g)(2)(F)(ii), knowingly submit such an application that
makes a materially false, fictitious, or fraudulent
statement, or knowingly fail to provide promptly any
information requested by the Secretary to review such an
application;
``(G) cause there to be a difference (including a
difference in active ingredient, route of administration,
dosage form, strength, formulation, manufacturing
establishment, manufacturing process, or person that
manufactures the drug) between a prescription drug for
distribution in the United States and the drug for
distribution in a permitted country;
``(H) refuse to allow an inspection authorized under this
section of an establishment that manufactures a qualifying
drug that is, or will be, introduced for commercial
distribution in a permitted country;
``(I) fail to conform to the methods used in, or the
facilities used for, the manufacturing, processing, packing,
or holding of a qualifying drug that is, or will be,
introduced for commercial distribution in a permitted country
to good manufacturing practice under this Act;
``(J) become a party to a licensing agreement or other
agreement related to a qualifying drug that fails to provide
for compliance with all requirements of this section with
respect to such drug;
``(K) enter into a contract that restricts, prohibits, or
delays the importation of a qualifying drug under this
section;
``(L) engage in any other action to restrict, prohibit, or
delay the importation of a qualifying drug under this
section; or
``(M) engage in any other action that the Federal Trade
Commission determines to discriminate against a person that
engages or attempts to engage in the importation of a
qualifying drug under this section.
``(2) Referral of potential violations.--The Secretary
shall promptly refer to the Federal Trade Commission each
potential violation of subparagraph (E), (F), (G), (H), or
(I) of paragraph (1) that becomes known to the Secretary.
``(3) Affirmative defense.--
``(A) Discrimination.--It shall be an affirmative defense
to a charge that a manufacturer has discriminated under
subparagraph (A), (B), (C), (D), or (M) of paragraph (1) that
the higher price charged for a prescription drug sold to a
person, the denial, restriction, or delay of supplies of a
prescription drug to a person, the refusal to do business
with a person, or other discriminatory activity against a
person, is not based, in whole or in part, on--
``(i) the person exporting or importing a qualifying drug
into the United States under this section; or
``(ii) the person distributing, selling, or using a
qualifying drug imported into the United States under this
section.
``(B) Drug differences.--It shall be an affirmative defense
to a charge that a manufacturer has caused there to be a
difference described in subparagraph (G) of paragraph (1)
that--
``(i) the difference was required by the country in which
the drug is distributed;
``(ii) the Secretary has determined that the difference was
necessary to improve the safety or effectiveness of the drug;
``(iii) the person manufacturing the drug for distribution
in the United States has given notice to the Secretary under
subsection (g)(2)(B)(i) that the drug for distribution in the
United States is not different from a drug for distribution
in permitted countries whose combined population represents
at least 50 percent of the total population of all permitted
countries; or
``(iv) the difference was not caused, in whole or in part,
for the purpose of restricting importation of the drug into
the United States under this section.
``(4) Effect of subsection.--
``(A) Sales in other countries.--This subsection applies
only to the sale or distribution of a prescription drug in a
country if the manufacturer of the drug chooses to sell or
distribute the drug in the country. Nothing in this
subsection shall be construed to compel the manufacturer of a
drug to distribute or sell the drug in a country.
``(B) Discounts to insurers, health plans, pharmacy benefit
managers, and covered entities.--Nothing in this subsection
shall be construed to--
``(i) prevent or restrict a manufacturer of a prescription
drug from providing discounts to an insurer, health plan,
pharmacy benefit manager in the United States, or covered
entity in the drug discount program under section 340B of the
Public Health Service Act (42 U.S.C. 256b) in return for
inclusion of the drug on a formulary;
``(ii) require that such discounts be made available to
other purchasers of the prescription drug; or
``(iii) prevent or restrict any other measures taken by an
insurer, health plan, or pharmacy benefit manager to
encourage consumption of such prescription drug.
``(C) Charitable contributions.--Nothing in this subsection
shall be construed to--
``(i) prevent a manufacturer from donating a prescription
drug, or supplying a prescription drug at nominal cost, to a
charitable or

[[Page S5416]]

humanitarian organization, including the United Nations and
affiliates, or to a government of a foreign country; or
``(ii) apply to such donations or supplying of a
prescription drug.
``(5) Enforcement.--
``(A) Unfair or deceptive act or practice.--A violation of
this subsection shall be treated as a violation of a rule
defining an unfair or deceptive act or practice prescribed
under section 18(a)(1)(B) of the Federal Trade Commission Act
(15 U.S.C. 57a(a)(1)(B)).
``(B) Actions by the commission.--The Federal Trade
Commission--
``(i) shall enforce this subsection in the same manner, by
the same means, and with the same jurisdiction, powers, and
duties as though all applicable terms and provisions of the
Federal Trade Commission Act (15 U.S.C. 41 et seq.) were
incorporated into and made a part of this section; and
``(ii) may seek monetary relief threefold the damages
sustained, in addition to any other remedy available to the
Federal Trade Commission under the Federal Trade Commission
Act (15 U.S.C. 41 et seq.).
``(6) Actions by states.--
``(A) In general.--
``(i) Civil actions.--In any case in which the attorney
general of a State has reason to believe that an interest of
the residents of that State have been adversely affected by
any manufacturer that violates paragraph (1), the attorney
general of a State may bring a civil action on behalf of the
residents of the State, and persons doing business in the
State, in a district court of the United States of
appropriate jurisdiction to--

``(I) enjoin that practice;
``(II) enforce compliance with this subsection;
``(III) obtain damages, restitution, or other compensation
on behalf of residents of the State and persons doing
business in the State, including threefold the damages; or
``(IV) obtain such other relief as the court may consider
to be appropriate.

``(ii) Notice.--

``(I) In general.--Before filing an action under clause
(i), the attorney general of the State involved shall provide
to the Federal Trade Commission--

``(aa) written notice of that action; and
``(bb) a copy of the complaint for that action.

``(II) Exemption.--Subclause (I) shall not apply with
respect to the filing of an action by an attorney general of
a State under this paragraph, if the attorney general
determines that it is not feasible to provide the notice
described in that subclause before filing of the action. In
such case, the attorney general of a State shall provide
notice and a copy of the complaint to the Federal Trade
Commission at the same time as the attorney general files the
action.

``(B) Intervention.--
``(i) In general.--On receiving notice under subparagraph
(A)(ii), the Federal Trade Commission shall have the right to
intervene in the action that is the subject of the notice.
``(ii) Effect of intervention.--If the Federal Trade
Commission intervenes in an action under subparagraph (A), it
shall have the right--

``(I) to be heard with respect to any matter that arises in
that action; and
``(II) to file a petition for appeal.

``(C) Construction.--For purposes of bringing any civil
action under subparagraph (A), nothing in this subsection
shall be construed to prevent an attorney general of a State
from exercising the powers conferred on the attorney general
by the laws of that State to--
``(i) conduct investigations;
``(ii) administer oaths or affirmations; or
``(iii) compel the attendance of witnesses or the
production of documentary and other evidence.
``(D) Actions by the commission.--In any case in which an
action is instituted by or on behalf of the Federal Trade
Commission for a violation of paragraph (1), a State may not,
during the pendency of that action, institute an action under
subparagraph (A) for the same violation against any defendant
named in the complaint in that action.
``(E) Venue.--Any action brought under subparagraph (A) may
be brought in the district court of the United States that
meets applicable requirements relating to venue under section
1391 of title 28, United States Code.
``(F) Service of process.--In an action brought under
subparagraph (A), process may be served in any district in
which the defendant--
``(i) is an inhabitant; or
``(ii) may be found.
``(G) Measurement of damages.--In any action under this
paragraph to enforce a cause of action under this subsection
in which there has been a determination that a defendant has
violated a provision of this subsection, damages may be
proved and assessed in the aggregate by statistical or
sampling methods, by the computation of illegal overcharges
or by such other reasonable system of estimating aggregate
damages as the court in its discretion may permit without the
necessity of separately proving the individual claim of, or
amount of damage to, persons on whose behalf the suit was
brought.
``(H) Exclusion on duplicative relief.--The district court
shall exclude from the amount of monetary relief awarded in
an action under this paragraph brought by the attorney
general of a State any amount of monetary relief which
duplicates amounts which have been awarded for the same
injury.
``(7) Effect on antitrust laws.--Nothing in this subsection
shall be construed to modify, impair, or supersede the
operation of the antitrust laws. For the purpose of this
subsection, the term `antitrust laws' has the meaning given
it in the first section of the Clayton Act, except that it
includes section 5 of the Federal Trade Commission Act to the
extent that such section 5 applies to unfair methods of
competition.
``(8) Manufacturer.--In this subsection, the term
`manufacturer' means any entity, including any affiliate or
licensee of that entity, that is engaged in--
``(A) the production, preparation, propagation,
compounding, conversion, or processing of a prescription
drug, either directly or indirectly by extraction from
substances of natural origin, or independently by means of
chemical synthesis, or by a combination of extraction and
chemical synthesis; or
``(B) the packaging, repackaging, labeling, relabeling, or
distribution of a prescription drug.''.
(b) Prohibited Acts.--The Federal Food, Drug, and Cosmetic
Act is amended--
(1) in section 301 (21 U.S.C. 331), by striking paragraph
(aa) and inserting the following:
``(aa)(1) The sale or trade by a pharmacist, or by a
business organization of which the pharmacist is a part, of a
qualifying drug that under section 804(a)(2)(A) was imported
by the pharmacist, other than--
``(A) a sale at retail made pursuant to dispensing the drug
to a customer of the pharmacist or organization; or
``(B) a sale or trade of the drug to a pharmacy or a
wholesaler registered to import drugs under section 804.
``(2) The sale or trade by an individual of a qualifying
drug that under section 804(a)(2)(B) was imported by the
individual.
``(3) The making of a materially false, fictitious, or
fraudulent statement or representation, or a material
omission, in a notice under clause (i) of section
804(g)(2)(B) or in an application required under section
804(g)(2)(F), or the failure to submit such a notice or
application.
``(4) The importation of a drug in violation of a
registration condition or other requirement under section
804, the falsification of any record required to be
maintained, or provided to the Secretary, under such section,
or the violation of any registration condition or other
requirement under such section.''; and
(2) in section 303(a) (21 U.S.C. 333(a)), by striking
paragraph (6) and inserting the following:
``(6) Notwithstanding subsection (a), any person that
knowingly violates section 301(i) (2) or (3) or section
301(aa)(4) shall be imprisoned not more than 10 years, or
fined in accordance with title 18, United States Code, or
both.''.
(c) Amendment of Certain Provisions.--
(1) In general.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended by striking
subsection (g) and inserting the following:
``(g) With respect to a prescription drug that is imported
or offered for import into the United States by an individual
who is not in the business of such importation, that is not
shipped by a registered exporter under section 804, and that
is refused admission under subsection (a), the Secretary
shall notify the individual that--
``(1) the drug has been refused admission because the drug
was not a lawful import under section 804;
``(2) the drug is not otherwise subject to a waiver of the
requirements of subsection (a);
``(3) the individual may under section 804 lawfully import
certain prescription drugs from exporters registered with the
Secretary under section 804; and
``(4) the individual can find information about such
importation, including a list of registered exporters, on the
Internet website of the Food and Drug Administration or
through a toll-free telephone number required under section
804.''.
(2) Establishment registration.--Section 510(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is
amended in paragraph (1) by inserting after ``import into the
United States'' the following: ``, including a drug that is,
or may be, imported or offered for import into the United
States under section 804,''.
(3) Effective date.--The amendments made by this subsection
shall take effect on the date that is 90 days after the date
of enactment of this title.
(d) Exhaustion.--
(1) In general.--Section 271 of title 35, United States
Code, is amended--
(A) by redesignating subsections (h) and (i) as (i) and
(j), respectively; and
(B) by inserting after subsection (g) the following:
``(h) It shall not be an act of infringement to use, offer
to sell, or sell within the United States or to import into
the United States any patented invention under section 804 of
the Federal Food, Drug, and Cosmetic Act that was first sold
abroad by or under authority of the owner or licensee of such
patent.''.
(2) Rule of construction.--Nothing in the amendment made by
paragraph (1) shall be construed to affect the ability of a
patent owner or licensee to enforce their patent, subject to
such amendment.
(e) Effect of Section 804.--
(1) In general.--Section 804 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), shall permit the
importation

[[Page S5417]]

of qualifying drugs (as defined in such section 804) into the
United States without regard to the status of the issuance of
implementing regulations--
(A) from exporters registered under such section 804 on the
date that is 90 days after the date of enactment of this
title; and
(B) from permitted countries, as defined in such section
804, by importers registered under such section 804 on the
date that is 1 year after the date of enactment of this
title.
(2) Review of registration by certain exporters.--
(A) Review priority.--In the review of registrations
submitted under subsection (b) of such section 804,
registrations submitted by entities in Canada that are
significant exporters of prescription drugs to individuals in
the United States as of the date of enactment of this title
will have priority during the 90 day period that begins on
such date of enactment.
(B) Period for review.--During such 90-day period, the
reference in subsection (b)(2)(A) of such section 804 to 90
days (relating to approval or disapproval of registrations)
is, as applied to such entities, deemed to be 30 days.
(C) Limitation.--That an exporter in Canada exports, or has
exported, prescription drugs to individuals in the United
States on or before the date that is 90 days after the date
of enactment of this title shall not serve as a basis, in
whole or in part, for disapproving a registration under such
section 804 from the exporter.
(D) First year limit on number of exporters.--During the 1-
year period beginning on the date of enactment of this title,
the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') may limit the number of
registered exporters under such section 804 to not less than
50, so long as the Secretary gives priority to those
exporters with demonstrated ability to process a high volume
of shipments of drugs to individuals in the United States.
(E) Second year limit on number of exporters.--During the
1-year period beginning on the date that is 1 year after the
date of enactment of this title, the Secretary may limit the
number of registered exporters under such section 804 to not
less than 100, so long as the Secretary gives priority to
those exporters with demonstrated ability to process a high
volume of shipments of drugs to individuals in the United
States.
(F) Further limit on number of exporters.--During any 1-
year period beginning on a date that is 2 or more years after
the date of enactment of this title, the Secretary may limit
the number of registered exporters under such section 804 to
not less than 25 more than the number of such exporters
during the previous 1-year period, so long as the Secretary
gives priority to those exporters with demonstrated ability
to process a high volume of shipments of drugs to individuals
in the United States.
(3) Limits on number of importers.--
(A) First year limit on number of importers.--During the 1-
year period beginning on the date that is 1 year after the
date of enactment of this title, the Secretary may limit the
number of registered importers under such section 804 to not
less than 100 (of which at least a significant number shall
be groups of pharmacies, to the extent feasible given the
applications submitted by such groups), so long as the
Secretary gives priority to those importers with demonstrated
ability to process a high volume of shipments of drugs
imported into the United States.
(B) Second year limit on number of importers.--During the
1-year period beginning on the date that is 2 years after the
date of enactment of this title, the Secretary may limit the
number of registered importers under such section 804 to not
less than 200 (of which at least a significant number shall
be groups of pharmacies, to the extent feasible given the
applications submitted by such groups), so long as the
Secretary gives priority to those importers with demonstrated
ability to process a high volume of shipments of drugs into
the United States.
(C) Further limit on number of importers.--During any 1-
year period beginning on a date that is 3 or more years after
the date of enactment of this title, the Secretary may limit
the number of registered importers under such section 804 to
not less than 50 more (of which at least a significant number
shall be groups of pharmacies, to the extent feasible given
the applications submitted by such groups) than the number of
such importers during the previous 1-year period, so long as
the Secretary gives priority to those importers with
demonstrated ability to process a high volume of shipments of
drugs to the United States.
(4) Notices for drugs for import from canada.--The notice
with respect to a qualifying drug introduced for commercial
distribution in Canada as of the date of enactment of this
title that is required under subsection (g)(2)(B)(i) of such
section 804 shall be submitted to the Secretary not later
than 30 days after the date of enactment of this title if--
(A) the U.S. label drug (as defined in such section 804)
for the qualifying drug is 1 of the 100 prescription drugs
with the highest dollar volume of sales in the United States
based on the 12 calendar month period most recently completed
before the date of enactment of this Act; or
(B) the notice is a notice under subsection
(g)(2)(B)(i)(II) of such section 804.
(5) Notice for drugs for import from other countries.--The
notice with respect to a qualifying drug introduced for
commercial distribution in a permitted country other than
Canada as of the date of enactment of this title that is
required under subsection (g)(2)(B)(i) of such section 804
shall be submitted to the Secretary not later than 180 days
after the date of enactment of this title if--
(A) the U.S. label drug for the qualifying drug is 1 of the
100 prescription drugs with the highest dollar volume of
sales in the United States based on the 12 calendar month
period that is first completed on the date that is 120 days
after the date of enactment of this title; or
(B) the notice is a notice under subsection
(g)(2)(B)(i)(II) of such section 804.
(6) Notice for other drugs for import.--
(A) Guidance on submission dates.--The Secretary shall by
guidance establish a series of submission dates for the
notices under subsection (g)(2)(B)(i) of such section 804
with respect to qualifying drugs introduced for commercial
distribution as of the date of enactment of this title and
that are not required to be submitted under paragraph (4) or
(5).
(B) Consistent and efficient use of resources.--The
Secretary shall establish the dates described under
subparagraph (A) so that such notices described under
subparagraph (A) are submitted and reviewed at a rate that
allows consistent and efficient use of the resources and
staff available to the Secretary for such reviews. The
Secretary may condition the requirement to submit such a
notice, and the review of such a notice, on the submission by
a registered exporter or a registered importer to the
Secretary of a notice that such exporter or importer intends
to import such qualifying drug to the United States under
such section 804.
(C) Priority for drugs with higher sales.--The Secretary
shall establish the dates described under subparagraph (A) so
that the Secretary reviews the notices described under such
subparagraph with respect to qualifying drugs with higher
dollar volume of sales in the United States before the
notices with respect to drugs with lower sales in the United
States.
(7) Notices for drugs approved after effective date.--The
notice required under subsection (g)(2)(B)(i) of such section
804 for a qualifying drug first introduced for commercial
distribution in a permitted country (as defined in such
section 804) after the date of enactment of this title shall
be submitted to and reviewed by the Secretary as provided
under subsection (g)(2)(B) of such section 804, without
regard to paragraph (4), (5), or (6).
(8) Report.--Beginning with the first full fiscal year
after the date of enactment of this title, not later than 90
days after the end of each fiscal year during which the
Secretary reviews a notice referred to in paragraph (4), (5),
or (6), the Secretary shall submit a report to Congress
concerning the progress of the Food and Drug Administration
in reviewing the notices referred to in paragraphs (4), (5),
and (6).
(9) User fees.--
(A) Exporters.--When establishing an aggregate total of
fees to be collected from exporters under subsection (f)(2)
of such section 804, the Secretary shall, under subsection
(f)(3)(C)(i) of such section 804, estimate the total price of
drugs imported under subsection (a) of such section 804 into
the United States by registered exporters during the first
fiscal year in which this title takes effect to be an amount
equal to the amount which bears the same ratio to
$1,000,000,000 as the number of days in such fiscal year
during which this title is effective bears to 365.
(B) Importers.--When establishing an aggregate total of
fees to be collected from importers under subsection (e)(2)
of such section 804, the Secretary shall, under subsection
(e)(3)(C)(i) of such section 804, estimate the total price of
drugs imported under subsection (a) of such section 804 into
the United States by registered importers during--
(i) the first fiscal year in which this title takes effect
to be an amount equal to the amount which bears the same
ratio to $1,000,000,000 as the number of days in such fiscal
year during which this title is effective bears to 365; and
(ii) the second fiscal year in which this title is in
effect to be $3,000,000,000.
(C) Second year adjustment.--
(i) Reports.--Not later than February 20 of the second
fiscal year in which this title is in effect, registered
importers shall report to the Secretary the total price and
the total volume of drugs imported to the United States by
the importer during the 4-month period from October 1 through
January 31 of such fiscal year.
(ii) Reestimate.--Notwithstanding subsection (e)(3)(C)(ii)
of such section 804 or subparagraph (B), the Secretary shall
reestimate the total price of qualifying drugs imported under
subsection (a) of such section 804 into the United States by
registered importers during the second fiscal year in which
this title is in effect. Such reestimate shall be equal to--

(I) the total price of qualifying drugs imported by each
importer as reported under clause (i); multiplied by
(II) 3.

(iii) Adjustment.--The Secretary shall adjust the fee due
on April 1 of the second fiscal year in which this title is
in effect, from each importer so that the aggregate total of
fees collected under subsection (e)(2) for such fiscal year
does not exceed the total price of

[[Page S5418]]

qualifying drugs imported under subsection (a) of such
section 804 into the United States by registered importers
during such fiscal year as reestimated under clause (ii).
(D) Failure to pay fees.--Notwithstanding any other
provision of this section, the Secretary may prohibit a
registered importer or exporter that is required to pay user
fees under subsection (e) or (f) of such section 804 and that
fails to pay such fees within 30 days after the date on which
it is due, from importing or offering for importation a
qualifying drug under such section 804 until such fee is
paid.
(E) Annual report.--
(i) Food and drug administration.--Not later than 180 days
after the end of each fiscal year during which fees are
collected under subsection (e), (f), or (g)(2)(B)(iv) of such
section 804, the Secretary shall prepare and submit to the
House of Representatives and the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected for the fiscal year for which the
report is made and credited to the Food and Drug
Administration.
(ii) Customs and border control.--Not later than 180 days
after the end of each fiscal year during which fees are
collected under subsection (e) or (f) of such section 804,
the Secretary of Homeland Security, in consultation with the
Secretary of the Treasury, shall prepare and submit to the
House of Representatives and the Senate a report on the use,
by the Bureau of Customs and Border Protection, of the fees,
if any, transferred by the Secretary to the Bureau of Customs
and Border Protection for the fiscal year for which the
report is made.
(10) Special rule regarding importation by individuals.--
(A) In general.--Notwithstanding any provision of this
title (or an amendment made by this title), the Secretary
shall expedite the designation of any additional countries
from which an individual may import a qualifying drug into
the United States under such section 804 if any action
implemented by the Government of Canada has the effect of
limiting or prohibiting the importation of qualifying drugs
into the United States from Canada.
(B) Timing and criteria.--The Secretary shall designate
such additional countries under subparagraph (A)--
(i) not later than 6 months after the date of the action by
the Government of Canada described under such subparagraph;
and
(ii) using the criteria described under subsection
(a)(4)(D)(i)(II) of such section 804.
(f) Implementation of Section 804.--
(1) Interim rule.--The Secretary may promulgate an interim
rule for implementing section 804 of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a) of this section.
(2) No notice of proposed rulemaking.--The interim rule
described under paragraph (1) may be developed and
promulgated by the Secretary without providing general notice
of proposed rulemaking.
(3) Final rule.--Not later than 1 year after the date on
which the Secretary promulgates an interim rule under
paragraph (1), the Secretary shall, in accordance with
procedures under section 553 of title 5, United States Code,
promulgate a final rule for implementing such section 804,
which may incorporate by reference provisions of the interim
rule provided for under paragraph (1), to the extent that
such provisions are not modified.
(g) Consumer Education.--The Secretary shall carry out
activities that educate consumers--
(1) with regard to the availability of qualifying drugs for
import for personal use from an exporter registered with and
approved by the Food and Drug Administration under section
804 of the Federal Food, Drug, and Cosmetic Act, as added by
this section, including information on how to verify whether
an exporter is registered and approved by use of the Internet
website of the Food and Drug Administration and the toll-free
telephone number required by this title;
(2) that drugs that consumers attempt to import from an
exporter that is not registered with and approved by the Food
and Drug Administration can be seized by the United States
Customs Service and destroyed, and that such drugs may be
counterfeit, unapproved, unsafe, or ineffective;
(3) with regard to the suspension and termination of any
registration of a registered importer or exporter under such
section 804; and
(4) with regard to the availability at domestic retail
pharmacies of qualifying drugs imported under such section
804 by domestic wholesalers and pharmacies registered with
and approved by the Food and Drug Administration.
(h) Effect on Administration Practices.--Notwithstanding
any provision of this title (and the amendments made by this
title), the practices and policies of the Food and Drug
Administration and Bureau of Customs and Border Protection,
in effect on January 1, 2004, with respect to the importation
of prescription drugs into the United States by an
individual, on the person of such individual, for personal
use, shall remain in effect.
(i) Report to Congress.--The Federal Trade Commission
shall, on an annual basis, submit to Congress a report that
describes any action taken during the period for which the
report is being prepared to enforce the provisions of section
804(n) of the Federal Food, Drug, and Cosmetic Act (as added
by this title), including any pending investigations or civil
actions under such section.

SEC. _05. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION INTO
UNITED STATES.

(a) In General.--Chapter VIII of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381 et seq.), as amended by
section _04, is further amended by adding at the end the
following section:

``SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION.

``(a) In General.--The Secretary of Homeland Security shall
deliver to the Secretary a shipment of drugs that is imported
or offered for import into the United States if--
``(1) the shipment has a declared value of less than
$10,000; and
``(2)(A) the shipping container for such drugs does not
bear the markings required under section 804(d)(2); or
``(B) the Secretary has requested delivery of such shipment
of drugs.
``(b) No Bond or Export.--Section 801(b) does not authorize
the delivery to the owner or consignee of drugs delivered to
the Secretary under subsection (a) pursuant to the execution
of a bond, and such drugs may not be exported.
``(c) Destruction of Violative Shipment.--The Secretary
shall destroy a shipment of drugs delivered by the Secretary
of Homeland Security to the Secretary under subsection (a)
if--
``(1) in the case of drugs that are imported or offered for
import from a registered exporter under section 804, the
drugs are in violation of any standard described in section
804(g)(5); or
``(2) in the case of drugs that are not imported or offered
for import from a registered exporter under section 804, the
drugs are in violation of a standard referred to in section
801(a) or 801(d)(1).
``(d) Certain Procedures.--
``(1) In general.--The delivery and destruction of drugs
under this section may be carried out without notice to the
importer, owner, or consignee of the drugs except as required
by section 801(g) or section 804(i)(2). The issuance of
receipts for the drugs, and recordkeeping activities
regarding the drugs, may be carried out on a summary basis.
``(2) Objective of procedures.--Procedures promulgated
under paragraph (1) shall be designed toward the objective of
ensuring that, with respect to efficiently utilizing Federal
resources available for carrying out this section, a
substantial majority of shipments of drugs subject to
described in subsection (c) are identified and destroyed.
``(e) Evidence Exception.--Drugs may not be destroyed under
subsection (c) to the extent that the Attorney General of the
United States determines that the drugs should be preserved
as evidence or potential evidence with respect to an offense
against the United States.
``(f) Rule of Construction.--This section may not be
construed as having any legal effect on applicable law with
respect to a shipment of drugs that is imported or offered
for import into the United States and has a declared value
equal to or greater than $10,000.''.
(b) Procedures.--Procedures for carrying out section 805 of
the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), shall be established not later than 90 days
after the date of the enactment of this title.
(c) Effective Date.--The amendments made by this section
shall take effect on the date that is 90 days after the date
of enactment of this title.

SEC. _06. WHOLESALE DISTRIBUTION OF DRUGS; STATEMENTS
REGARDING PRIOR SALE, PURCHASE, OR TRADE.

(a) Striking of Exemptions; Applicability to Registered
Exporters.--Section 503(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353(e)) is amended--
(1) in paragraph (1)--
(A) by striking ``and who is not the manufacturer or an
authorized distributor of record of such drug'';
(B) by striking ``to an authorized distributor of record
or''; and
(C) by striking subparagraph (B) and inserting the
following:
``(B) The fact that a drug subject to subsection (b) is
exported from the United States does not with respect to such
drug exempt any person that is engaged in the business of the
wholesale distribution of the drug from providing the
statement described in subparagraph (A) to the person that
receives the drug pursuant to the export of the drug.
``(C)(i) The Secretary shall by regulation establish
requirements that supersede subparagraph (A) (referred to in
this subparagraph as `alternative requirements') to identify
the chain of custody of a drug subject to subsection (b) from
the manufacturer of the drug throughout the wholesale
distribution of the drug to a pharmacist who intends to sell
the drug at retail if the Secretary determines that the
alternative requirements, which may include standardized
anti-counterfeiting or track-and-trace technologies, will
identify such chain of custody or the identity of the
discrete package of the drug from which the drug is dispensed
with equal or greater certainty to the requirements of
subparagraph (A), and that the alternative requirements are
economically and technically feasible.
``(ii) When the Secretary promulgates a final rule to
establish such alternative requirements, the final rule in
addition shall, with respect to the registration condition
established in clause (i) of section 804(c)(3)(B),

[[Page S5419]]

establish a condition equivalent to the alternative
requirements, and such equivalent condition may be met in
lieu of the registration condition established in such clause
(i).'';
(2) in paragraph (2)(A), by adding at the end the
following: ``The preceding sentence may not be construed as
having any applicability with respect to a registered
exporter under section 804.''; and
(3) in paragraph (3), by striking ``and subsection (d)--''
in the matter preceding subparagraph (A) and all that follows
through ``the term `wholesale distribution' means'' in
subparagraph (B) and inserting the following: ``and
subsection (d), the term `wholesale distribution' means''.
(b) Conforming Amendment.--Section 503(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 353(d)) is amended by
adding at the end the following:
``(4) Each manufacturer of a drug subject to subsection (b)
shall maintain at its corporate offices a current list of the
authorized distributors of record of such drug.
``(5) For purposes of this subsection, the term `authorized
distributors of record' means those distributors with whom a
manufacturer has established an ongoing relationship to
distribute such manufacturer's products.''.
(c) Effective Date.--
(1) In general.--The amendments made by paragraphs (1) and
(3) of subsection (a) and by subsection (b) shall take effect
on January 1, 2010.
(2) Drugs imported by registered importers under section
804.--Notwithstanding paragraph (1), the amendments made by
paragraphs (1) and (3) of subsection (a) and by subsection
(b) shall take effect on the date that is 90 days after the
date of enactment of this title with respect to qualifying
drugs imported under section 804 of the Federal Food, Drug,
and Cosmetic Act, as added by section _04.
(3) Effect with respect to registered exporters.--The
amendment made by subsection (a)(2) shall take effect on the
date that is 90 days after the date of enactment of this
title.
(4) Alternative requirements.--The Secretary shall issue
regulations to establish the alternative requirements,
referred to in the amendment made by subsection (a)(1), that
take effect not later than January 1, 2010.
(5) Intermediate requirements.--The Secretary shall by
regulation require the use of standardized anti-
counterfeiting or track-and-trace technologies on
prescription drugs at the case and pallet level effective not
later than 1 year after the date of enactment of this title.
(6) Additional requirements.--
(A) In general.--Notwithstanding any other provision of
this section, the Secretary shall, not later than 18 months
after the date of enactment of this title, require that the
packaging of any prescription drug incorporates--
(i) a standardized numerical identifier unique to each
package of such drug, applied at the point of manufacturing
and repackaging (in which case the numerical identifier shall
be linked to the numerical identifier applied at the point of
manufacturing); and
(ii)(I) overt optically variable counterfeit-resistant
technologies that--

(aa) are visible to the naked eye, providing for visual
identification of product authenticity without the need for
readers, microscopes, lighting devices, or scanners;
(bb) are similar to that used by the Bureau of Engraving
and Printing to secure United States currency;
(cc) are manufactured and distributed in a highly secure,
tightly controlled environment; and
(dd) incorporate additional layers of nonvisible convert
security features up to and including forensic capability, as
described in subparagraph (B); or

(II) technologies that have a function of security
comparable to that described in subclause (I), as determined
by the Secretary.
(B) Standards for packaging.--For the purpose of making it
more difficult to counterfeit the packaging of drugs subject
to this paragraph, the manufacturers of such drugs shall
incorporate the technologies described in subparagraph (A)
into at least 1 additional element of the physical packaging
of the drugs, including blister packs, shrink wrap, package
labels, package seals, bottles, and boxes.

SEC. _07. INTERNET SALES OF PRESCRIPTION DRUGS.

(a) In General.--Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 503A the following:

``SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS.

``(a) Requirements Regarding Information on Internet
Site.--
``(1) In general.--A person may not dispense a prescription
drug pursuant to a sale of the drug by such person if--
``(A) the purchaser of the drug submitted the purchase
order for the drug, or conducted any other part of the sales
transaction for the drug, through an Internet site;
``(B) the person dispenses the drug to the purchaser by
mailing or shipping the drug to the purchaser; and
``(C) such site, or any other Internet site used by such
person for purposes of sales of a prescription drug, fails to
meet each of the requirements specified in paragraph (2),
other than a site or pages on a site that--
``(i) are not intended to be accessed by purchasers or
prospective purchasers; or
``(ii) provide an Internet information location tool within
the meaning of section 231(e)(5) of the Communications Act of
1934 (47 U.S.C. 231(e)(5)).
``(2) Requirements.--With respect to an Internet site, the
requirements referred to in subparagraph (C) of paragraph (1)
for a person to whom such paragraph applies are as follows:
``(A) Each page of the site shall include either the
following information or a link to a page that provides the
following information:
``(i) The name of such person.
``(ii) Each State in which the person is authorized by law
to dispense prescription drugs.
``(iii) The address and telephone number of each place of
business of the person with respect to sales of prescription
drugs through the Internet, other than a place of business
that does not mail or ship prescription drugs to purchasers.
``(iv) The name of each individual who serves as a
pharmacist for prescription drugs that are mailed or shipped
pursuant to the site, and each State in which the individual
is authorized by law to dispense prescription drugs.
``(v) If the person provides for medical consultations
through the site for purposes of providing prescriptions, the
name of each individual who provides such consultations; each
State in which the individual is licensed or otherwise
authorized by law to provide such consultations or practice
medicine; and the type or types of health professions for
which the individual holds such licenses or other
authorizations.
``(B) A link to which paragraph (1) applies shall be
displayed in a clear and prominent place and manner, and
shall include in the caption for the link the words
`licensing and contact information'.
``(b) Internet Sales Without Appropriate Medical
Relationships.--
``(1) In general.--Except as provided in paragraph (2), a
person may not dispense a prescription drug, or sell such a
drug, if--
``(A) for purposes of such dispensing or sale, the
purchaser communicated with the person through the Internet;
``(B) the patient for whom the drug was dispensed or
purchased did not, when such communications began, have a
prescription for the drug that is valid in the United States;
``(C) pursuant to such communications, the person provided
for the involvement of a practitioner, or an individual
represented by the person as a practitioner, and the
practitioner or such individual issued a prescription for the
drug that was purchased;
``(D) the person knew, or had reason to know, that the
practitioner or the individual referred to in subparagraph
(C) did not, when issuing the prescription, have a qualifying
medical relationship with the patient; and
``(E) the person received payment for the dispensing or
sale of the drug.
For purposes of subparagraph (E), payment is received if
money or other valuable consideration is received.
``(2) Exceptions.--Paragraph (1) does not apply to--
``(A) the dispensing or selling of a prescription drug
pursuant to telemedicine practices sponsored by--
``(i) a hospital that has in effect a provider agreement
under title XVIII of the Social Security Act (relating to the
Medicare program); or
``(ii) a group practice that has not fewer than 100
physicians who have in effect provider agreements under such
title; or
``(B) the dispensing or selling of a prescription drug
pursuant to practices that promote the public health, as
determined by the Secretary by regulation.
``(3) Qualifying medical relationship.--
``(A) In general.--With respect to issuing a prescription
for a drug for a patient, a practitioner has a qualifying
medical relationship with the patient for purposes of this
section if--
``(i) at least one in-person medical evaluation of the
patient has been conducted by the practitioner; or
``(ii) the practitioner conducts a medical evaluation of
the patient as a covering practitioner.
``(B) In-person medical evaluation.--A medical evaluation
by a practitioner is an in-person medical evaluation for
purposes of this section if the practitioner is in the
physical presence of the patient as part of conducting the
evaluation, without regard to whether portions of the
evaluation are conducted by other health professionals.
``(C) Covering practitioner.--With respect to a patient, a
practitioner is a covering practitioner for purposes of this
section if the practitioner conducts a medical evaluation of
the patient at the request of a practitioner who has
conducted at least one in-person medical evaluation of the
patient and is temporarily unavailable to conduct the
evaluation of the patient. A practitioner is a covering
practitioner without regard to whether the practitioner has
conducted any in-person medical evaluation of the patient
involved.
``(4) Rules of construction.--
``(A) Individuals represented as practitioners.--A person
who is not a practitioner (as defined in subsection (e)(1))
lacks legal capacity under this section to have a qualifying
medical relationship with any patient.

[[Page S5420]]

``(B) Standard practice of pharmacy.--Paragraph (1) may not
be construed as prohibiting any conduct that is a standard
practice in the practice of pharmacy.
``(C) Applicability of requirements.--Paragraph (3) may not
be construed as having any applicability beyond this section,
and does not affect any State law, or interpretation of State
law, concerning the practice of medicine.
``(c) Actions by States.--
``(1) In general.--Whenever an attorney general of any
State has reason to believe that the interests of the
residents of that State have been or are being threatened or
adversely affected because any person has engaged or is
engaging in a pattern or practice that violates section
301(l), the State may bring a civil action on behalf of its
residents in an appropriate district court of the United
States to enjoin such practice, to enforce compliance with
such section (including a nationwide injunction), to obtain
damages, restitution, or other compensation on behalf of
residents of such State, to obtain reasonable attorneys fees
and costs if the State prevails in the civil action, or to
obtain such further and other relief as the court may deem
appropriate.
``(2) Notice.--The State shall serve prior written notice
of any civil action under paragraph (1) or (5)(B) upon the
Secretary and provide the Secretary with a copy of its
complaint, except that if it is not feasible for the State to
provide such prior notice, the State shall serve such notice
immediately upon instituting such action. Upon receiving a
notice respecting a civil action, the Secretary shall have
the right--
``(A) to intervene in such action;
``(B) upon so intervening, to be heard on all matters
arising therein; and
``(C) to file petitions for appeal.
``(3) Construction.--For purposes of bringing any civil
action under paragraph (1), nothing in this chapter shall
prevent an attorney general of a State from exercising the
powers conferred on the attorney general by the laws of such
State to conduct investigations or to administer oaths or
affirmations or to compel the attendance of witnesses or the
production of documentary and other evidence.
``(4) Venue; service of process.--Any civil action brought
under paragraph (1) in a district court of the United States
may be brought in the district in which the defendant is
found, is an inhabitant, or transacts business or wherever
venue is proper under section 1391 of title 28, United States
Code. Process in such an action may be served in any district
in which the defendant is an inhabitant or in which the
defendant may be found.
``(5) Actions by other state officials.--
``(A) Nothing contained in this section shall prohibit an
authorized State official from proceeding in State court on
the basis of an alleged violation of any civil or criminal
statute of such State.
``(B) In addition to actions brought by an attorney general
of a State under paragraph (1), such an action may be brought
by officers of such State who are authorized by the State to
bring actions in such State on behalf of its residents.
``(d) Effect of Section.--This section shall not apply to a
person that is a registered exporter under section 804.
``(e) General Definitions.--For purposes of this section:
``(1) The term `practitioner' means a practitioner referred
to in section 503(b)(1) with respect to issuing a written or
oral prescription.
``(2) The term `prescription drug' means a drug that is
described in section 503(b)(1).
``(3) The term `qualifying medical relationship', with
respect to a practitioner and a patient, has the meaning
indicated for such term in subsection (b).
``(f) Internet-Related Definitions.--
``(1) In general.--For purposes of this section:
``(A) The term `Internet' means collectively the myriad of
computer and telecommunications facilities, including
equipment and operating software, which comprise the
interconnected world-wide network of networks that employ the
transmission control protocol/internet protocol, or any
predecessor or successor protocols to such protocol, to
communicate information of all kinds by wire or radio.
``(B) The term `link', with respect to the Internet, means
one or more letters, words, numbers, symbols, or graphic
items that appear on a page of an Internet site for the
purpose of serving, when activated, as a method for executing
an electronic command--
``(i) to move from viewing one portion of a page on such
site to another portion of the page;
``(ii) to move from viewing one page on such site to
another page on such site; or
``(iii) to move from viewing a page on one Internet site to
a page on another Internet site.
``(C) The term `page', with respect to the Internet, means
a document or other file accessed at an Internet site.
``(D)(i) The terms `site' and `address', with respect to
the Internet, mean a specific location on the Internet that
is determined by Internet Protocol numbers. Such term
includes the domain name, if any.
``(ii) The term `domain name' means a method of
representing an Internet address without direct reference to
the Internet Protocol numbers for the address, including
methods that use designations such as `.com', `.edu', `.gov',
`.net', or `.org'.
``(iii) The term `Internet Protocol numbers' includes any
successor protocol for determining a specific location on the
Internet.
``(2) Authority of secretary.--The Secretary may by
regulation modify any definition under paragraph (1) to take
into account changes in technology.
``(g) Interactive Computer Service; Advertising.--No
provider of an interactive computer service, as defined in
section 230(f)(2) of the Communications Act of 1934 (47
U.S.C. 230(f)(2)), or of advertising services shall be liable
under this section for dispensing or selling prescription
drugs in violation of this section on account of another
person's selling or dispensing such drugs, provided that the
provider of the interactive computer service or of
advertising services does not own or exercise corporate
control over such person.''.
(b) Inclusion as Prohibited Act.--Section 301 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is
amended by inserting after paragraph (k) the following:
``(l) The dispensing or selling of a prescription drug in
violation of section 503B.''.
(c) Internet Sales of Prescription Drugs; Consideration by
Secretary of Practices and Procedures for Certification of
Legitimate Businesses.--In carrying out section 503B of the
Federal Food, Drug, and Cosmetic Act (as added by subsection
(a) of this section), the Secretary of Health and Human
Services shall take into consideration the practices and
procedures of public or private entities that certify that
businesses selling prescription drugs through Internet sites
are legitimate businesses, including practices and procedures
regarding disclosure formats and verification programs.
(d) Reports Regarding Internet-Related Violations of
Federal and State Laws on Dispensing of Drugs.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this subsection as the ``Secretary'') shall,
pursuant to the submission of an application meeting the
criteria of the Secretary, make an award of a grant or
contract to the National Clearinghouse on Internet
Prescribing (operated by the Federation of State Medical
Boards) for the purpose of--
(A) identifying Internet sites that appear to be in
violation of Federal or State laws concerning the dispensing
of drugs;
(B) reporting such sites to State medical licensing boards
and State pharmacy licensing boards, and to the Attorney
General and the Secretary, for further investigation; and
(C) submitting, for each fiscal year for which the award
under this subsection is made, a report to the Secretary
describing investigations undertaken with respect to
violations described in subparagraph (A).
(2) Authorization of appropriations.--For the purpose of
carrying out paragraph (1), there is authorized to be
appropriated $100,000 for each of the first 3 fiscal years in
which this section is in effect.
(e) Effective Date.--The amendments made by subsections (a)
and (b) take effect 90 days after the date of enactment of
this title, without regard to whether a final rule to
implement such amendments has been promulgated by the
Secretary of Health and Human Services under section 701(a)
of the Federal Food, Drug, and Cosmetic Act. The preceding
sentence may not be construed as affecting the authority of
such Secretary to promulgate such a final rule.

SEC. _08. PROHIBITING PAYMENTS TO UNREGISTERED FOREIGN
PHARMACIES.

(a) In General.--Section 303 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end
the following:
``(g) Restricted Transactions.--
``(1) In general.--The introduction of restricted
transactions into a payment system or the completion of
restricted transactions using a payment system is prohibited.
``(2) Payment system.--
``(A) In general.--The term `payment system' means a system
used by a person described in subparagraph (B) to effect a
credit transaction, electronic fund transfer, or money
transmitting service that may be used in connection with, or
to facilitate, a restricted transaction, and includes--
``(i) a credit card system;
``(ii) an international, national, regional, or local
network used to effect a credit transaction, an electronic
fund transfer, or a money transmitting service; and
``(iii) any other system that is centrally managed and is
primarily engaged in the transmission and settlement of
credit transactions, electronic fund transfers, or money
transmitting services.
``(B) Persons described.--A person referred to in
subparagraph (A) is--
``(i) a creditor;
``(ii) a credit card issuer;
``(iii) a financial institution;
``(iv) an operator of a terminal at which an electronic
fund transfer may be initiated;
``(v) a money transmitting business; or
``(vi) a participant in an international, national,
regional, or local network used to effect a credit
transaction, electronic fund transfer, or money transmitting
service.
``(3) Restricted transaction.--The term `restricted
transaction' means a transaction or transmittal, on behalf of
an individual who places an unlawful drug importation request
to any person engaged in the operation of an unregistered
foreign pharmacy, of--

[[Page S5421]]

``(A) credit, or the proceeds of credit, extended to or on
behalf of the individual for the purpose of the unlawful drug
importation request (including credit extended through the
use of a credit card);
``(B) an electronic fund transfer or funds transmitted by
or through a money transmitting business, or the proceeds of
an electronic fund transfer or money transmitting service,
from or on behalf of the individual for the purpose of the
unlawful drug importation request;
``(C) a check, draft, or similar instrument which is drawn
by or on behalf of the individual for the purpose of the
unlawful drug importation request and is drawn on or payable
at or through any financial institution; or
``(D) the proceeds of any other form of financial
transaction (identified by the Board by regulation) that
involves a financial institution as a payor or financial
intermediary on behalf of or for the benefit of the
individual for the purpose of the unlawful drug importation
request.
``(4) Unlawful drug importation request.--The term
`unlawful drug importation request' means the request, or
transmittal of a request, made to an unregistered foreign
pharmacy for a prescription drug by mail (including a private
carrier), facsimile, phone, or electronic mail, or by a means
that involves the use, in whole or in part, of the Internet.
``(5) Unregistered foreign pharmacy.--The term
`unregistered foreign pharmacy' means a person in a country
other than the United States that is not a registered
exporter under section 804.
``(6) Other definitions.--
``(A) Credit; creditor; credit card.--The terms `credit',
`creditor', and `credit card' have the meanings given the
terms in section 103 of the Truth in Lending Act (15 U.S.C.
1602).
``(B) Access device; electronic fund transfer.--The terms
`access device' and `electronic fund transfer'--
``(i) have the meaning given the term in section 903 of the
Electronic Fund Transfer Act (15 U.S.C. 1693a); and
``(ii) the term `electronic fund transfer' also includes
any fund transfer covered under Article 4A of the Uniform
Commercial Code, as in effect in any State.
``(C) Financial institution.--The term `financial
institution'--
``(i) has the meaning given the term in section 903 of the
Electronic Transfer Fund Act (15 U.S.C. 1693a); and
``(ii) includes a financial institution (as defined in
section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809)).
``(D) Money transmitting business; money transmitting
service.--The terms `money transmitting business' and `money
transmitting service' have the meaning given the terms in
section 5330(d) of title 31, United States Code.
``(E) Board.--The term `Board' means the Board of Governors
of the Federal Reserve System.
``(7) Policies and procedures required to prevent
restricted transactions.--
``(A) Regulations.--The Board shall promulgate regulations
requiring--
``(i) an operator of a credit card system;
``(ii) an operator of an international, national, regional,
or local network used to effect a credit transaction, an
electronic fund transfer, or a money transmitting service;
``(iii) an operator of any other payment system that is
centrally managed and is primarily engaged in the
transmission and settlement of credit transactions,
electronic transfers or money transmitting services where at
least one party to the transaction or transfer is an
individual; and
``(iv) any other person described in paragraph (2)(B) and
specified by the Board in such regulations,

to establish policies and procedures that are reasonably
designed to prevent the introduction of a restricted
transaction into a payment system or the completion of a
restricted transaction using a payment system
``(B) Requirements for policies and procedures.--In
promulgating regulations under subparagraph (A), the Board
shall--
``(i) identify types of policies and procedures, including
nonexclusive examples, that shall be considered to be
reasonably designed to prevent the introduction of restricted
transactions into a payment system or the completion of
restricted transactions using a payment system; and
``(ii) to the extent practicable, permit any payment
system, or person described in paragraph (2)(B), as
applicable, to choose among alternative means of preventing
the introduction or completion of restricted transactions.
``(C) No liability for blocking or refusing to honor
restricted transaction.--
``(i) In general.--A payment system, or a person described
in paragraph (2)(B) that is subject to a regulation issued
under this subsection, and any participant in such payment
system that prevents or otherwise refuses to honor
transactions in an effort to implement the policies and
procedures required under this subsection or to otherwise
comply with this subsection shall not be liable to any party
for such action.
``(ii) Compliance.--A person described in paragraph (2)(B)
meets the requirements of this subsection if the person
relies on and complies with the policies and procedures of a
payment system of which the person is a member or in which
the person is a participant, and such policies and procedures
of the payment system comply with the requirements of the
regulations promulgated under subparagraph (A).
``(D) Enforcement.--
``(i) In general.--This section shall be enforced by the
Federal functional regulators and the Federal Trade
Commission under applicable law in the manner provided in
section 505(a) of the Gramm-Leach-Bliley Act (15 U.S.C.
6805(a)).
``(ii) Factors to be considered.--In considering any
enforcement action under this subsection against a payment
system or person described in paragraph (2)(B), the Federal
functional regulators and the Federal Trade Commission shall
consider the following factors:

``(I) The extent to which the payment system or person
knowingly permits restricted transactions.
``(II) The history of the payment system or person in
connection with permitting restricted transactions.
``(III) The extent to which the payment system or person
has established and is maintaining policies and procedures in
compliance with regulations prescribed under this subsection.

``(8) Transactions permitted.--A payment system, or a
person described in paragraph (2)(B) that is subject to a
regulation issued under this subsection, is authorized to
engage in transactions with foreign pharmacies in connection
with investigating violations or potential violations of any
rule or requirement adopted by the payment system or person
in connection with complying with paragraph (7). A payment
system, or such a person, and its agents and employees shall
not be found to be in violation of, or liable under, any
Federal, State or other law by virtue of engaging in any such
transaction.
``(9) Relation to state laws.--No requirement, prohibition,
or liability may be imposed on a payment system, or a person
described in paragraph (2)(B) that is subject to a regulation
issued under this subsection, under the laws of any state
with respect to any payment transaction by an individual
because the payment transaction involves a payment to a
foreign pharmacy.
``(10) Timing of requirements.--A payment system, or a
person described in paragraph (2)(B) that is subject to a
regulation issued under this subsection, must adopt policies
and procedures reasonably designed to comply with any
regulations required under paragraph (7) within 60 days after
such regulations are issued in final form.''.
(b) Effective Date.--The amendment made by this section
shall take effect on the day that is 90 days after the date
of enactment of this Act.
(c) Implementation.--The Board of Governors of the Federal
Reserve System shall promulgate regulations as required by
subsection (g)(7) of section 303 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 333), as added by subsection (a),
not later than 90 days after the date of enactment of this
title.

SEC. _09. IMPORTATION EXEMPTION UNDER CONTROLLED SUBSTANCES
IMPORT AND EXPORT ACT.

Section 1006(a)(2) of the Controlled Substances Import and
Export Act (21 U.S.C. 956(a)(2)) is amended by striking ``not
import the controlled substance into the United States in an
amount that exceeds 50 dosage units of the controlled
substance.'' and inserting ``import into the United States
not more than 10 dosage units combined of all such controlled
substances.''.

SEC. _10. SEVERABILITY.

If any provision of this title, an amendment by this title,
or the application of such provision or amendment to any
person or circumstance is held to be unconstitutional, the
remainder of this title, the amendments made by this title,
and the application of the provisions of such to any person
or circumstance shall not affected thereby.
______

SA 991. Mr. KOHL (for himself, Mr. Grassley, Mr. Leahy, and Mr.
Schumer) submitted an amendment intended to be proposed by him to the
bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to
reauthorize and amend the prescription drug user fee provisions, and
for other purposes; which was ordered to lie on the table; as follows:

At the end of the bill, insert the following:

TITLE__PRESERVE ACCESS TO AFFORDABLE GENERICS ACT

SEC. _01. SHORT TITLE.

This title may be cited as the ``Preserve Access to
Affordable Generics Act''.

SEC. _02. CONGRESSIONAL FINDINGS AND DECLARATION OF PURPOSES.

(a) Findings.--The Congress finds that--
(1) prescription drugs make up 11 percent of the national
health care spending but are 1 of the largest and fastest
growing health care expenditures;
(2) 56 percent of all prescriptions dispensed in the United
States are generic drugs, yet they account for only 13percent
of all expenditures;
(3) generic drugs, on average, cost 63 percent less than
their brand-name counterparts;
(4) consumers and the health care system would benefit from
free and open competition in the pharmaceutical market and
the removal of obstacles to the introduction of generic
drugs;

[[Page S5422]]

(5) full and free competition in the pharmaceutical
industry, and the full enforcement of antitrust law to
prevent anticompetitive practices in this industry, will lead
to lower prices, greater innovation, and inure to the general
benefit of consumers.
(6) the Federal Trade Commission has determined that some
brand name pharmaceutical manufacturers collude with generic
drug manufacturers to delay the marketing of competing, low-
cost, generic drugs;
(7) collusion by the brand name pharmaceutical
manufacturers is contrary to free competition, to the
interests of consumers, and to the principles underlying
antitrust law;
(8) in 2005, 2 appellate court decisions reversed the
Federal Trade Commission's long-standing position, and upheld
settlements that include pay-offs by brand name
pharmaceutical manufacturers to generic manufacturers
designed to keep generic competition off the market;
(9) in the 6 months following the March 2005 court
decisions, the Federal Trade Commission found there were
three settlement agreements in which the generic received
compensation and agreed to a restriction on its ability to
market the product;
(10) the FTC found that more than \2/3\ of the
approximately ten settlement agreements made in 2006 include
a pay-off from the brand in exchange for a promise by the
generic company to delay entry into the market; and
(11) settlements which include a payment from a brand name
manufacturer to a generic manufacturer to delay entry by
generic drugs are anti-competitive and contrary to the
interests of consumers.
(b) Purposes.--The purposes of this title are--
(1) to enhance competition in the pharmaceutical market by
prohibiting anticompetitive agreements and collusion between
brand name and generic drug manufacturers intended to keep
generic drugs off the market;
(2) to support the purpose and intent of antitrust law by
prohibiting anticompetitive agreements and collusion in the
pharmaceutical industry; and
(3) to clarify the law to prohibit payments from brand name
to generic drug manufacturers with the purpose to prevent or
delay the entry of competition from generic drugs.

SEC. 3. UNLAWFUL COMPENSATION FOR DELAY.

(a) In General.--The Clayton Act (15 U.S.C. 12 et seq.) is
amended by inserting after section 28 the following:

``SEC. 29. UNLAWFUL INTERFERENCE WITH GENERIC MARKETING.

``(a) It shall be unlawful under this Act for any person,
in connection with the sale of a drug product, to directly or
indirectly be a party to any agreement resolving or settling
a patent infringement claim which--
``(1) an ANDA filer receives anything of value; and
``(2) the ANDA filer agrees not to research, develop,
manufacture, market, or sell the ANDA product for any period
of time.
``(b) Nothing in this section shall prohibit a resolution
or settlement of patent infringement claim in which the value
paid by the NDA holder to the ANDA filer as a part of the
resolution or settlement of the patent infringement claim
includes no more than the right to market the ANDA product
prior to the expiration of the patent that is the basis for
the patent infringement claim.
``(c) In this section:
``(1) The term `agreement' means anything that would
constitute an agreement under section 1 of the Sherman Act
(15 U.S.C. 1) or section 5 of the Federal Trade Commission
Act (15 U.S.C. 45).
``(2) The term `agreement resolving or settling a patent
infringement claim' includes, any agreement that is
contingent upon, provides a contingent condition for, or is
otherwise related to the resolution or settlement of the
claim.
``(3) The term `ANDA' means an abbreviated new drug
application, as defined under section 505(j) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
``(4) The term `ANDA filer' means a party who has filed an
ANDA with the Federal Drug Administration.
``(5) The term `ANDA product' means the product to be
manufactured under the ANDA that is the subject of the patent
infringement claim.
``(6) The term `drug product' means a finished dosage form
(e.g., tablet, capsule, or solution) that contains a drug
substance, generally, but not necessarily, in association
with 1 or more other ingredients, as defined in section
314.3(b) of title 21, Code of Federal Regulations.
``(7) The term `NDA' means a new drug application, as
defined under section 505(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)).
``(8) The term `NDA holder' means--
``(A) the party that received FDA approval to market a drug
product pursuant to an NDA;
``(B) a party owning or controlling enforcement of the
patent listed in the Approved Drug Products With Therapeutic
Equivalence Evaluations (commonly known as the `FDA Orange
Book') in connection with the NDA; or
``(C) the predecessors, subsidiaries, divisions, groups,
and affiliates controlled by, controlling, or under common
control with any of the entities described in subclauses (i)
and (ii) (such control to be presumed by direct or indirect
share ownership of 50 percent or greater), as well as the
licensees, licensors, successors, and assigns of each of the
entities.
``(9) The term `patent infringement' means infringement of
any patent or of any filed patent application, extension,
reissue, renewal, division, continuation, continuation in
part, reexamination, patent term restoration, patents of
addition and extensions thereof.
``(10) The term `patent infringement claim' means any
allegation made to an ANDA filer, whether or not included in
a complaint filed with a court of law, that its ANDA or ANDA
product may infringe any patent held by, or exclusively
licensed to, the NDA holder of the drug product.''.
(b) Regulations.--The Federal Trade Commission may, by rule
promulgated under section 553 of title 5, United States Code,
exempt certain agreements described in the section 29 of the
Clayton Act, as added by subsection (a), if the Commission
finds such agreements to be in furtherance of market
competition and for the benefit of consumers. Consistent with
the authority of Commission, such rules may include
interpretive rules and general statements of policy with
respect to the practices prohibited under section 29 of the
Clayton Act.

SEC. _04. NOTICE AND CERTIFICATION OF AGREEMENTS.

(a) Notice of All Agreements.--Section 1112(c)(2) of the
Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (21 U.S.C. 3155 note) is amended by--
(1) striking ``the Commission the'' and inserting ``the
Commission (1) the''; and
(2) inserting before the period at the end the following:
``; and (2) a description of the subject matter of any other
agreement the parties enter into within 30 days of an
entering into an agreement covered by subsection (a) or
(b)''.
(b) Certification of Agreements.--Section 1112 of such Act
is amended by adding at the end the following:
``(d) Certification.--The Chief Executive Officer or the
company official responsible for negotiating any agreement
required to be filed under subsection (a), (b), or (c) shall
execute and file with the Assistant Attorney General and the
Commission a certification as follows: `I declare under
penalty of perjury that the following is true and correct:
The materials filed with the Federal Trade Commission and the
Department of Justice under section 1112 of subtitle B of
title XI of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, with respect to the agreement
referenced in this certification: (1) represent the complete,
final, and exclusive agreement between the parties; (2)
include any ancillary agreements that are contingent upon,
provide a contingent condition for, or are otherwise related
to, the referenced agreement; and (3) include written
descriptions of any oral agreements, representations,
commitments, or promises between the parties that are
responsive to subsection (a) or (b) of such section 1112 and
have not been reduced to writing.'.''.

SEC. _05. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.

Section 505 of the Federal Food, Drug and Cosmetic Act (21
U.S.C. 355(j)(5)(D)(i)(V)) is amended by inserting ``section
28 of the Clayton Act or'' after ``that the agreement has
violated''.

SEC. _06. STUDY BY THE FEDERAL TRADE COMMISSION.

(a) Requirement for a Study.--Not later than 180 days after
the date of enactment of this Act and pursuant to its
authority under section 6(a) of the Federal Trade Commission
Act (15 U.S.C. 46(a)) and its jurisdiction to prevent unfair
methods of competition, the Federal Trade Commission shall
conduct a study regarding--
(1) the prevalence of agreements in patent infringement
suits of the type described in section 29 of the Clayton Act,
as added by this title, during the last 5 years;
(2) the impact of such agreements on competition in the
pharmaceutical market; and
(3) the prevalence in the pharmaceutical industry of other
anticompetitive agreements among competitors or other
practices that are contrary to the antitrust laws, and the
impact of such agreements or practices on competition in the
pharmaceutical market during the last 5 years.
(b) Consultation.--In conducting the study required under
this section, the Federal Trade Commission shall consult with
the Antitrust Division of the Department of Justice regarding
the Justice Department's findings and investigations
regarding anticompetitive practices in the pharmaceutical
market, including criminal antitrust investigations completed
by the Justice Department with respect to practices or
conduct in the pharmaceutical market.
(c) Requirement for a Report.--Not later than 1 year after
the date of enactment of this Act, the Federal Trade
Commission shall submit a report to the Judiciary Committees
of Senate and House of Representatives, and to the Department
of Justice regarding the findings of the study conducted
under subsection (a). This report shall contain the Federal
Trade Commission's recommendation as to whether any amendment
to the antitrust laws should be enacted to correct any
substantial lessening of competition found during the study.
(d) Federal Agency Consideration.--Upon receipt of the
report required by subsection (c), the Attorney General or
the Chairman of the Federal Trade Commission, as appropriate,
shall consider whether any additional

[[Page S5423]]

enforcement action is required to restore competition or
prevent a substantial lessening of competition occurring as a
result of the conduct or practices that were the subject of
the study conducted under subsection (b).

SEC. _07. AUTHORIZATION OF APPROPRIATIONS.

There are authorized to be appropriated to the Federal
Trade Commission such sums as may be necessary to carry out
the provisions of this title.

______

SA 992. Mr. KOHL submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY
ACTION.

Section 505(j)(5) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)(5)) is amended by adding at the end the
following:
``(G)(i) Notwithstanding any other provision of law, any
petition submitted under section 10.30 or section 10.35 of
title 21, Code of Federal Regulations (or any successor
regulation), shall include a statement that to the
petitioner's best knowledge and belief, the petition--
``(I) includes all information and views on which the
petitioner relies, including all representative data and
information known to the petitioner that is favorable or
unfavorable to the petition;
``(II) is well grounded in fact and is warranted by law;
``(III) is not submitted for an improper purpose, such as
to harass or cause unnecessary delay (including unnecessary
delay of competition or agency action); and
``(IV) does not contain a materially false, misleading, or
fraudulent statement.
``(ii) The Secretary shall investigate, on receipt of a
complaint, a request under clause (vi), or on its own
initiative, any petition submitted under such section 10.30
or section 10.35 (or any successor regulation), that--
``(I) does not comply with the requirements of clause (i);
``(II) may have been submitted for an improper purpose as
described in clause (i)(III); or
``(III) may contain a materially false, misleading, or
fraudulent statement as described in clause (i)(IV).
``(iii) If the Secretary finds that the petitioner has
knowingly and willingly submitted the petition for an
improper purpose as described in clause (i)(III), or which
contains a materially false, misleading, or fraudulent
statement as described in clause (i)(IV), the Secretary may--
``(I) impose a civil penalty of not more than $1,000,000,
plus attorneys fees and costs of reviewing the petition and
any related proceedings;
``(II) suspend the authority of the petitioner to submit a
petition under such section 10.30 or section 10.35 (or any
successor regulation), for a period of not more than 10
years;
``(III) revoke permanently the authority of the petitioner
to submit a petition under such section 10.30 or section
10.35 (or any successor regulation); or
``(IV) dismiss the petition at issue in its entirety.
``(iv) If the Secretary takes an enforcement action
described in subclause (I), (II), (III), or (IV) of clause
(iii) with respect to a petition, the Secretary shall refer
that petition to the Federal Trade Commission for further
action as the Federal Trade Commission finds appropriate.
``(v) In determining whether to take an enforcement action
described in subclause (I), (II), (III), or (IV) of clause
(iii) with respect to a petition, and in determining the
amount of any civil penalty or the length of any suspension
imposed under that clause, the Secretary shall consider the
specific circumstances of the situation, such as the gravity
and seriousness of the violation involved, the amount of
resources expended in reviewing the petition at issue, the
effect on marketing of competing drugs of the pendency of the
improperly submitted petition, including whether the timing
of the submission of the petition appears to have been
calculated to cause delay in the marketing of any drug
awaiting approval, and whether the petitioner has a history
of submitting petitions in violation of this subparagraph.
``(vi)(I) Any person aggrieved by a petition filed under
such section 10.30 or section 10.35 (or any successor
regulation), including a person filing an application under
subsection (b)(2) or (j) of this section to which such
petition relates, may request that the Secretary initiate an
investigation described under clause (ii) for an enforcement
action described under clause (iii).
``(II) The aggrieved person shall specify the basis for its
belief that the petition at issue is false, misleading,
fraudulent, or submitted for an improper purpose. The
aggrieved person shall certify that the request is submitted
in good faith, is well grounded in fact, and not submitted
for any improper purpose. Any aggrieved person who knowingly
and intentionally violates the preceding sentence shall be
subject to the civil penalty described under clause (iii)(I).
``(vii) The Secretary shall take final agency action with
respect to a petition filed under such section 10.30 or
section 10.35 (or any successor regulation) regarding an
abbreviated new drug application within 6 months of receipt
of such petition. The Secretary shall not extend such 6-month
review period, even with consent of the petitioner, for any
reason, including based upon the submission of comments
relating to a petition or supplemental information supplied
by the petitioner. If the Secretary has not taken final
agency action on a petition regarding an abbreviated new drug
application by the date that is 6 months after the date of
receipt of the petition, such petition shall be deemed to
have been denied on such date.
``(viii) The Secretary may promulgate regulations to carry
out this subparagraph, including to determine whether
petitions filed under such section 10.30 or section 10.35 (or
any successor regulation) merit enforcement action by the
Secretary under this subparagraph.''.
______

SA 993. Mr. GREGG submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

TITLE _--INTERNET PHARMACIES

SEC. _01. SHORT TITLE.

This title may be cited as the ``Safe Internet Pharmacy Act
of 2007''.

SEC. _02. INTERNET PHARMACIES.

(a) Internet Pharmacies.--Chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by
inserting after section 510 the following:

``SEC. 511. INTERNET PHARMACIES.

``(a) Definitions.--In this section:
``(1) Advertising service provider.--The term `advertising
service provider' means an advertising company that contracts
with a provider of an interactive computer service (as
defined in section 230(f) of the Communications Act of 1934
(47 U.S.C. 230(f)) to provide advertising on the Internet.
``(2) Designated payment system.--
``(A) In general.--The term `designated payment system'
means a system used by a person described in subparagraph (B)
to effect a credit transaction, electronic fund transfer, or
money transmitting service that the Board determines, by
regulation or order, is regularly used in connection with, or
to facilitate restricted transactions.
``(B) Persons described.--A person referred to in
subparagraph (A) is--
``(i) a creditor;
``(ii) a credit card issuer;
``(iii) a financial institution;
``(iv) an operator of a terminal at which an electronic
fund transfer may be initiated;
``(v) a money transmitting business; or
``(vi) a participant in an international, national,
regional, or local network constructed primarily to effect a
credit transaction, electronic fund transfer, or money
transmitting service.
``(3) Federal functional regulator.--The term `Federal
functional regulator' has the meaning given the term in
section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809).
``(4) Internet pharmacy.--The term `Internet pharmacy'
means a person that offers to dispense or dispenses in the
United States a prescription drug through an Internet website
in interstate commerce, regardless of whether the physical
location of the principal place of business of the Internet
pharmacy is in the United States or in another country.
``(5) Prescription drug.--The term `prescription drug'
means a drug described in section 503(b) that is approved by
the Secretary under section 505.
``(6) Restricted transaction.--The term `restricted
transaction' means a transaction or transmittal, on behalf of
a individual who places an unlawful Internet pharmacy request
to any person engaged in the operation of an unlicensed
Internet pharmacy, of--
``(A) credit, or the proceeds of credit, extended to or on
behalf of the individual for the purpose of the unlawful
Internet request (including credit extended through the use
of a credit card);
``(B) an electronic fund transfer or funds transmitted by
or through a money transmitting business, or the proceeds of
an electronic fund transfer or money transmitting service,
from or on behalf of the individual for the purpose of the
unlawful Internet request;
``(C) a check, draft, or similar instrument which is drawn
by or on behalf of the individual for the purpose of the
unlawful Internet request and is drawn on or payable at or
through any financial institution; or
``(D) the proceeds of any other form of financial
transaction (identified by the Board by regulation) that
involves a financial institution as a payor or financial
intermediary on behalf of or for the benefit of the
individual for the purpose of the unlawful Internet request.
``(7) Treating provider.--The term `treating provider'
means a health care provider licensed in the United States
who is authorized to prescribe medications and who--
``(A)(i) performs a documented patient evaluation
(including a patient history and physical examination) of an
individual, portions of which may be conducted by other
health professionals;

[[Page S5424]]

``(ii) discusses with the individual the treatment options
of the individual and the risks and benefits of treatment;
and
``(iii) maintains contemporaneous medical records
concerning the individual; or
``(B) provides care to an individual as part of an on-call
or cross-coverage arrangement with a health care provider
described in subparagraph (A).
``(8) Unlawful internet pharmacy request.--The term
`unlawful Internet pharmacy request' means the request, or
transmittal of a request, made to an unlicensed Internet
pharmacy for a prescription drug by mail (including a private
carrier), facsimile, telephone, or electronic mail, or by a
means that involves the use, in whole or in part, of the
Internet.
``(9) Unlicensed internet pharmacy.--The term `unlicensed
Internet pharmacy' means an Internet pharmacy that is not
licensed under this section.
``(10) Other definitions.--
``(A) Board.--The term `Board' means the Board of Governors
of the Federal Reserve System.
``(B) Credit; creditor; credit card.--The terms `credit',
`creditor', and `credit card' have the meanings given the
terms in section 103 of the Truth in Lending Act (15 U.S.C.
1602).
``(C) Electronic fund transfer.--The term `electronic fund
transfer'--
``(i) has the meaning given the term in section 903 of the
Electronic Fund Transfer Act (15 U.S.C. 1693a); and
``(ii) includes any fund transfer covered under article 4A
of the Uniform Commercial Code, as in effect in any State.
``(D) Financial institution.--The term `financial
institution'--
``(i) has the meaning given the term in section 903 of the
Electronic Transfer Fund Act (15 U.S.C. 1693a); and
``(ii) includes a financial institution (as defined in
section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809)).
``(E) Money transmitting business; money transmitting
service.--The terms `money transmitting business' and `money
transmitting service' have the meanings given the terms in
section 5330(d) of title 31, United States Code.
``(b) In General.--An Internet pharmacy may only dispense
or offer to dispense a prescription drug to a person in the
United States in accordance with this section.
``(c) Licensing of Internet Pharmacies.--
``(1) In general.--An Internet pharmacy shall be licensed
by the Secretary in accordance with this section prior to
offering to dispense or dispensing a prescription drug to an
individual.
``(2) Conditions for licensing.--
``(A) Application requirements.--An Internet pharmacy shall
submit to the Secretary an application that includes--
``(i)(I) in the case of an Internet pharmacy located in the
United States, verification that, in each State in which the
Internet pharmacy engages in dispensing or offering to
dispense prescription drugs, the Internet pharmacy, and all
employees and agents of the Internet pharmacy, is in
compliance with applicable Federal and State laws regarding--

``(aa) the practice of pharmacy, including licensing laws
and inspection requirements; and
``(bb) the manufacturing and distribution of controlled
substances, including with respect to mailing or shipping
controlled substances to consumers; or

``(II) in the case of an Internet pharmacy whose principal
place of business is located outside the United States,
verification that--

``(aa) all employees and agents of the Internet pharmacy
are in compliance with applicable Federal and State laws
regarding the practice of pharmacy, including licensing laws
and inspection requirements;
``(bb) the Internet pharmacy is in compliance with
applicable Federal and State laws regarding the practice of
pharmacy, including licensing laws and inspection
requirements;
``(cc) the Internet pharmacy expressly and affirmatively
agrees to provide and maintain an agent for service of
process in the United States;
``(dd) the Internet pharmacy expressly and affirmatively
agrees to be subject to the jurisdiction of the United States
and any of its States or territories where it engages in
commerce; and
``(ee) the Internet pharmacy agrees to affix to each
shipping container of drugs to be shipped in the United
States such markings as the Secretary determines to be
necessary to identify that the shipment is from a licensed
Internet pharmacy, which may include anticounterfeiting or
track-and-trace technologies;

``(ii) verification that the person that owns the Internet
pharmacy has not had a license for an Internet pharmacy
terminated by the Secretary, and that no other Internet
pharmacy owned by the person has had a license under this
subsection that has been terminated by the Secretary;
``(iii) verification from the person that owns the Internet
pharmacy that the person will permit inspection of the
facilities and business practices of the Internet pharmacy by
the Secretary to the extent necessary to determine whether
the Internet pharmacy is in compliance with this subsection;
``(iv) in the case of an agreement between a patient and an
Internet pharmacy that releases the Internet pharmacy, and
any employee or agent of the Internet pharmacy, from
liability for damages arising out of the negligence of the
Internet pharmacy, an assurance that such a limitation of
liability shall be null and void;
``(v) verification that the Internet pharmacy expressly and
affirmatively agrees to provide the Secretary with the
identity of any providers of interactive computer services
that provide host services or advertising services for the
Internet pharmacy; and
``(vi) assurance that the Internet pharmacy will comply
with the requirements under subparagraphs (B) and (C).
``(B) Identification requirements.--An Internet pharmacy
shall post in a clear and visible manner, on each page of the
website of the Internet pharmacy or by a link to a separate
page, the following information:
``(i) The street address, city, ZIP Code or comparable mail
code, State (or comparable entity), country, and telephone
number of--

``(I) each place of business of the Internet pharmacy; and
``(II) the name of the supervising pharmacist of the
Internet pharmacy and each individual who serves as a
pharmacist for purposes of the Internet pharmacy website.

``(ii) The names of all States in which the Internet
pharmacy and the pharmacists employed by the Internet
pharmacy are licensed or otherwise authorized to dispense
prescription drugs.
``(iii) If the Internet pharmacy makes referrals to, or
solicits on behalf of, a health care practitioner or group of
practitioners in the United States for prescription
services--

``(I) the name, street address, city, ZIP Code or
comparable mail code, State, and telephone number of the
practitioner or group; and
``(II) the name of each State in which each practitioner is
licensed or otherwise authorized to prescribe drugs.

``(iv) A statement that the Internet pharmacy will dispense
prescription drugs only after receipt of a valid prescription
from a treating provider.
``(v) A distinctive tamper resistant seal to identify that
the Internet pharmacy is licensed.
``(C) Professional services requirements.--An Internet
pharmacy shall carry out the following:
``(i) Maintain patient medication profiles and other
related data in a readily accessible format organized to
facilitate consultation with treating providers, caregivers,
and patients.
``(ii) Conduct prospective drug use reviews before
dispensing medications or medical devices.
``(iii) Ensure patient confidentiality and the protection
of patient identity and patient-specific information, in
accordance with the regulations promulgated under section
264(c) of the Health Insurance Portability and Accountability
Act of 1996.
``(iv) Offer interactive and meaningful consultation by a
licensed pharmacist to the caregiver or patient before and
after the time at which the Internet pharmacy dispenses the
drug.
``(v)(I) Establish a mechanism for patients to report
errors and suspected adverse drug reactions.
``(II) Document in the reporting mechanism the response of
the Internet pharmacy to those reports.
``(III) Submit those reports within 3 days of receipt and
the response of the Internet pharmacy to the Food and Drug
Administration in a manner determined appropriate by the
Secretary.
``(vi) Develop a system to inform caregivers and patients
about drug recalls.
``(vii) Educate caregivers and patients about the
appropriate means of disposing of expired, damaged, or
unusable medications.
``(viii) Assure that the sale of a prescription drug is in
accordance with a valid prescription from the treating
provider of the individual.
``(ix)(I) Verify the validity of the prescription of an
individual by using 1 of the following methods:

``(aa) If the prescription for any drug other than a
controlled substance (as defined in section 102 of the
Controlled Substances Act (21 U.S.C. 802)) is received from
an individual or the treating provider of the individual by
mail (including a private carrier), or from the treating
provider of the individual by electronic mail, the validity
of the prescription shall be confirmed in accordance with all
applicable Federal and State laws.
``(bb) If the prescription is for a controlled substance
(as defined in section 102 of the Controlled Substances Act),
the validity of the prescription shall be confirmed with the
treating provider as described in subclause (II).

``(II) When seeking verification of a prescription of an
individual under subclause (I)(bb), an Internet pharmacy
shall provide to the treating provider the following
information:

``(aa) The full name and address of the individual.
``(bb) Identification of the prescription drug.
``(cc) The quantity of the prescription drug to be
dispensed.
``(dd) The date on which the individual presented the
prescription to the Internet pharmacy.
``(ee) The date and time of the verification request.
``(ff) The name of a contact person at the Internet
pharmacy, including a voice telephone number, electronic mail
address, and facsimile telephone number.

[[Page S5425]]

``(III) A prescription is verified under subclause (I)(bb)
only if 1 of the following occurs:

``(aa) The treating provider confirms, by direct
communication with the Internet pharmacy, that the
prescription is accurate.
``(bb) The treating provider informs the Internet pharmacy
that the prescription is inaccurate and provides the accurate
prescription.

``(IV) An Internet pharmacy shall not fill a prescription
if--

``(aa) a treating provider informs the Internet pharmacy
within 72 hours after receipt of a communication under
subclause (I)(bb) that the prescription is inaccurate or
expired; or
``(bb) the treating provider does not respond within that
time.

``(x) Maintain, for such period of time as the Secretary
shall prescribe by regulation, a record of all direct
communications with a treating provider regarding the
dispensing of a prescription drug, including verification of
the prescription.
``(3) Licensure procedure.--
``(A) Action by secretary.--On receipt of a complete
licensing application from an Internet pharmacy under
paragraph (2), the Secretary shall--
``(i) assign an identification number to the Internet
pharmacy;
``(ii) notify the applicant of the receipt of the licensing
application; and
``(iii) if the Internet pharmacy is in compliance with the
conditions under paragraph (2), issue a license not later
than 60 days after receipt of a licensing application from
the Internet pharmacy.
``(B) Electronic filing.--
``(i) In general.--For the purpose of reducing paperwork
and reporting burdens, the Secretary shall require the use of
electronic methods of submitting to the Secretary a licensing
application required under this section and provide for
electronic methods of receiving the applications.
``(ii) Authentication.--In providing for the electronic
submission of such licensing applications under this section,
the Secretary shall ensure that adequate authentication
protocols are used to allow identification of the Internet
pharmacy and validation of the data as appropriate.
``(4) Database.--
``(A) In general.--The Secretary shall compile, maintain,
and periodically update a database of the Internet pharmacies
licensed under this section.
``(B) Availability.--The Secretary shall make the database
described under subparagraph (A) and information submitted by
the licensee under paragraph (2)(B) available to the public
on an Internet website and through a toll-free telephone
number.
``(5) Fees.--
``(A) In general.--
``(i) Licensing application fee.--The Secretary shall
establish a licensing application fee to be paid by all
applicants.
``(ii) Renewal fee.--The Secretary shall establish a yearly
renewal fee to be paid by all Internet pharmacies licensed
under this section.
``(B) Collection.--
``(i) Collection of licensing application fee.--A licensing
application fee payable for the fiscal year in which the
Internet pharmacy submits a licensing application, as
established under subparagraph (C), shall be payable upon the
submission to the Secretary of such licensing application.
``(ii) Collection of renewal fees.--After the licensing
application fee is paid for the first fiscal year of
licensure, the yearly renewal fee, as established under
subparagraph (C), shall be payable on or before October 1 of
each subsequent fiscal year.
``(iii) One fee per internet pharmacy.--The licensing
application fee and yearly renewal fee shall be paid only
once for each Internet pharmacy for a fiscal year in which
the fee is payable.
``(C) Fee amount.--The amount of the licensing application
fee and the yearly renewal fee for an Internet pharmacy shall
be determined each year by the Secretary based on the
anticipated costs to the Secretary of enforcing the
requirements of this section in the subsequent fiscal year.
``(D) Annual fee determination.--
``(i) In general.--Not later than 60 days before the
beginning of each fiscal year beginning after September 30,
2007, the Secretary shall determine the amount of the
licensing application fee and the yearly renewal fee for that
fiscal year.
``(ii) Publication of fee amount.--Not later than 60 days
before each fiscal year, the Secretary shall publish the
amount of the licensing application fee and the yearly
renewal fee under this section for that fiscal year and
provide for a period of 30 days for the public to provide
written comments on the fees.
``(E) Use of fees.--The fees collected under this section
shall be used, without further appropriation, to carry out
this section.
``(F) Failure to pay fee.--
``(i) Due date.--A fee payable under this section shall be
paid by the date that is 30 days after the date on which the
fee is due.
``(ii) Failure to pay.--If an Internet pharmacy subject to
a fee under this section fails to pay the fee by the date
specified under clause (i), the Secretary shall not permit
the Internet pharmacy to engage in the dispensing of drugs as
described under this section until all such fees owed by the
Internet pharmacy are paid.
``(G) Reports.--Beginning with fiscal year 2008, not later
than 60 days after the end of each fiscal year during which
licensing application fees are collected under this section,
the Secretary shall submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report that describes--
``(i) implementation of the licensing fee authority during
the fiscal year; and
``(ii) the use by the Secretary of the licensing fees
collected during the fiscal year for which the report is
made.
``(6) Suspension.--
``(A) In general.--If the Secretary determines that an
Internet pharmacy is engaged in a pattern of violations of
any of the requirements of this Act, the Secretary may
immediately order the suspension of the license of the
Internet pharmacy.
``(B) Appeal of suspension order.--An Internet pharmacy
subject to a suspension order under subparagraph (A) may
appeal the suspension order to the Secretary. Not later than
30 days after an appeal is filed, the Secretary, after
providing opportunity for an informal hearing, shall affirm
or terminate the order.
``(C) Failure to act.--If, during the 30-day period
specified in subparagraph (B), the Secretary fails to provide
an opportunity for a hearing or to affirm or terminate the
order, the order shall be deemed to be terminated.
``(D) No judicial review.--An order under this paragraph
shall not be subject to judicial review.
``(7) Termination of license.--The Secretary may terminate
a license issued under this subsection, after notice to the
Internet pharmacy and an opportunity for a hearing, and if
the Secretary determines that the Internet pharmacy--
``(A) has demonstrated a pattern of noncompliance with this
section;
``(B) has made an untrue statement of material fact in its
licensing application; or
``(C) is in violation of any applicable Federal or State
law relating to the dispensing of a prescription drug.
``(8) Renewal evaluation.--
``(A) In general.--Before renewing a license of an Internet
pharmacy under this subsection, the Secretary shall conduct
an evaluation to determine whether the Internet pharmacy is
in compliance with this section.
``(B) Evaluation of internet pharmacies.--At the discretion
of the Secretary and as applicable, an evaluation under
subparagraph (A) may include testing of the Internet pharmacy
website or other systems through which the Internet pharmacy
communicates with consumers, and a physical inspection of the
records and premises of the pharmacy.
``(9) Contract for operation of program.--
``(A) In general.--The Secretary may award a contract under
this subsection for the operation of the licensing program.
``(B) Term.--The duration of a contract under subparagraph
(A) shall not exceed 5 years and may be renewable.
``(C) Performance review.--The Secretary shall annually
review performance under a contract under subparagraph (A).
``(d) Providers of Interactive Computer Services or
Advertising Services.--No provider of interactive computer
services (as defined in section 230(f) of the Communications
Act of 1934 (47 U.S.C. 230(f)) or an advertising service
provider shall be liable under this section on account of
another person's selling or dispensing of a prescription
drug, so long as the provider of the interactive computer
service or the advertising service provider does not own or
exercise corporate control over such person.
``(e) Policies and Procedures Required To Prevent Payments
for Unlawful Internet Pharmacy Requests.--
``(1) Regulations.--Not later than 180 days after
designating a system under subsection (a)(2), the Board shall
promulgate regulations that require--
``(A) an operator of a credit card system that is a
designated payment system, an operator of an international,
national, or local network used to effect a credit
transaction, electronic fund transfer, or money transmitting
service that is a designated payment system, and an operator
of any other designated payment system specified by the Board
that is centrally managed and is primarily engaged in the
transmission and settlement of credit transactions,
electronic transfers, or money transmitting services where at
least 1 party to the transaction or transfer is an
individual; and
``(B) in the case of a designated payment system, other
than a designated payment system described in subparagraph
(A), a person described in subsection (a)(2)(B);

to establish policies and procedures that are reasonably
designed to prevent the introduction of restricted
transactions into a designated payment system or the
completion of restricted transactions using a designated
payment system.
``(2) Requirements for policies and procedures.--In
promulgating regulations under paragraph (1), the Board
shall--
``(A) identify types of policies and procedures, including
nonexclusive examples, that shall be considered to be
reasonably designed to identify and reasonably designed to
prevent the introduction of a restricted transaction in a
designated payment or the completion of restricted
transactions using a designated payment system; and

[[Page S5426]]

``(B) to the extent practicable, permit any designated
payment system, or person described in subsection (a)(2)(B),
as applicable, to choose among alternative means of
preventing the introduction or completion of restricted
transactions.
``(3) No liability for blocking or refusing to honor
restricted transaction.--
``(A) In general.--A designated payment system, or a person
described in subsection (a)(2)(B), that is subject to a
regulation or an order issued under this subsection, and any
participant in such payment system, that--
``(i) prevents or otherwise refuses to honor restricted
transactions, in an effort to implement the policies and
procedures required under this subsection or to otherwise
comply with this section, shall not be liable to any party
for such action; and
``(ii) prevents or otherwise refuses to honor a
nonrestricted transaction in an effort to implement the
policies and procedures under this subsection or to otherwise
comply with this section, shall not be liable to any party
for such action.
``(B) Compliance with this subsection.--A person described
in subsection (a)(2)(B) meets the requirements of this
subsection, if any, if the person relies on and complies with
the policies and procedures of a designated payment system of
which the person is a member or in which the person is a
participant, and such policies and procedures of the
designated payment system comply with the requirements of the
regulations under paragraph (1)(B).
``(4) Enforcement.--
``(A) In general.--This subsection shall be enforced by the
Federal functional regulators and the Federal Trade
Commission under applicable law in the manner provided in
section 505(a) of the Gramm-Leach-Bliley Act (21 U.S.C.
6805(a)).
``(B) Factors to be considered.--In considering any
enforcement action under this subsection against a payment
system or person described in subsection (a)(2)(B), the
Federal functional regulators and the Federal Trade
Commission shall consider the following factors:
``(i) The extent to which the payment system or person
knowingly permits restricted transactions.
``(ii) The history of the payment system or person in
connection with permitting restricted transactions.
``(iii) The extent to which the payment system or person
has established and is maintaining policies and procedures in
compliance with regulations prescribed under this subsection.
``(iv) The feasibility that any specific remedy prescribed
can be implemented by the payment system or person without
substantial deviation from normal business practice.
``(v) The costs and burdens the specific remedy will have
on the payment system or person.
``(f) Reports Regarding Internet-Related Violations of
Federal and State Laws on Dispensing of Drugs.--The Secretary
shall, pursuant to the submission of an application meeting
criteria prescribed by the Secretary, make an award of a
grant or contract to an entity with experience in developing
and maintaining systems for the purpose of--
``(1) identifying Internet pharmacy websites that are not
licensed or that appear to be operating in violation of
Federal or State laws concerning the dispensing of drugs;
``(2) reporting such Internet pharmacy websites to State
medical licensing boards and State pharmacy licensing boards,
and to the Attorney General and the Secretary, for further
investigation; and
``(3) submitting, for each fiscal year for which the award
under this subsection is made, a report to the Secretary
describing investigations undertaken with respect to
violations described in paragraph (1).
``(g) Transactions Permitted.--A designated payment system
or person subject to a regulation or an order issued under
subsection (e) may engage in transactions with licensed and
unlicensed Internet pharmacies in connection with
investigating violations or potential violations of any rule
or requirement adopted by the payment system or person in
connection with complying with subsection (e). A person
subject to a regulation or an order issued under subsection
(e) and the agents and employees of that person shall not be
found to be in violation of, or liable under, any Federal,
State, or other law for engaging in any such transaction.
``(h) Relation to State Laws.--No requirement, prohibition,
or liability may be imposed on a designated payment system or
person subject to a regulation or an order issued under
subsection (e) under the laws of any State with respect to
any payment transaction by an individual because the payment
transaction involves a payment to an Internet pharmacy.
``(i) Timing of Requirements.--A designated payment system
or a person subject to a regulation under subsection (e)
shall adopt policies and procedures reasonably designed to
comply with any regulations required under subsection (e) not
later than 180 days after the date on which such final
regulations are issued.''.
(b) Prohibited Acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding
at the end the following:
``(hh)(1) The sale, under section 511, of a drug that is
not a prescription drug, the sale of such a prescription drug
without a valid prescription from a treating provider, or the
ownership or operation of an Internet pharmacy, in violation
of section 511.
``(2) The representation by advertisement, sales
presentation, direct communication (including telephone,
facsimile, or electronic mail), or otherwise by an Internet
pharmacy, that a prescription drug may be obtained from the
Internet pharmacy without a prescription, in violation of
section 511.
``(3) The advertisement related to a prescription drug
through any media including sales presentation, direct
communication (including telephone, facsimile, or electronic
mail), by an unlicensed Internet pharmacy.
``(4) The provision of an untrue statement of material fact
in the licensing application of an Internet pharmacy.
``(5) For purposes of this subsection, any term used in
this subsection that is also used in section 511 shall have
the meaning given that term in section 511.''.
(c) Links to Unlicensed Internet Pharmacies.--Section 302
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332)
is amended by adding at the end the following:
``(c)(1) In the case of a violation of section 511 relating
to an unlicensed Internet pharmacy (as defined in such
section 511), the district courts of the United States and
the United States courts of the territories shall have
jurisdiction to order a provider of an interactive computer
service to remove, or disable access to, links to a website
violating that section that resides on a computer server that
the provider controls or operates.
``(2) Relief under paragraph (1)--
``(A) shall be available only after provision to the
provider of notice and an opportunity to appear;
``(B) shall not impose any obligation on the provider to
monitor its service or to affirmatively seek facts indicating
activity violating section 511;
``(C) shall specify the provider to which the relief
applies; and
``(D) shall specifically identify the location of the
website to be removed or to which access is to be
disabled.''.
(d) Regulations.--
(1) In general.--Not later than 1 year after the date of
enactment of this title, the Secretary of Health and Human
Services shall promulgate interim final regulations to carry
out the amendments made by this section.
(2) Effective date.--The requirement of licensure under
section 511 of the Federal Food, Drug, and Cosmetic Act (as
added by this section) shall take effect on the date
determined by the Secretary of Health and Human Services but
in no event later than 90 days after the effective date of
the interim final regulations under paragraph (1).
(e) Penalties.--Section 303 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end
the following:
``(g) Notwithstanding subsection (a), any person who
knowingly violates paragraph (1), (2), (3), or (4) of section
301(hh) shall be imprisoned for not more than 10 years or
fined in accordance with title 18, United States Code, or
both.''.
______

SA 994. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the appropriate place, insert the following:

SEC. __. CENTER FOR POSTMARKET EVALUATION AND RESEARCH FOR
DRUGS AND BIOLOGICS.

(a) In General.--Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 506C the following:

``SEC. 507. DRUG SAFETY.

``(a) Establishment of the Center for Postmarket Evaluation
and Research for Drugs and Biologics.--There is established
within the Food and Drug Administration a Center for
Postmarket Evaluation and Research for Drugs and Biologics
(referred to in the section as the `Center'). The Director of
the Center shall report directly to the Commissioner of Food
and Drugs.
``(b) Duties of the Center for Postmarket Evaluation and
Research for Drugs and Biologics.--
``(1) Responsibilities of director.--The Director of the
Center, in consultation with the Director of the Center for
Drug Evaluation and Research or the Director of the Center
for Biologics Evaluation and Research, as appropriate,
shall--
``(A) conduct postmarket risk assessment of drugs approved
under section 505 of this Act and of biological products
licensed under section 351 of the Public Health Service Act;
``(B) conduct and improve postmarket surveillance of
approved drugs and licensed biological products using
postmarket surveillance programs and activities (including
MedWatch), risk-benefit analyses, adverse event reports, the
scientific literature, any clinical or observational studies
(including studies required under subsection (d) or (e)), and
any other resources that the Director of the Center
determines appropriate;
``(C) determine whether a study is required under
subsection (d) or (e) and consult with the sponsors of drugs
and biological products to ensure that such studies are
completed by the date, and according to the terms, specified
by the Director of the Center;

[[Page S5427]]

``(D) contract, or require the sponsor of an application or
the holder of an approved application or license to contract,
with the holders of domestic and international patient
databases to conduct epidemiologic and other observational
studies;
``(E) determine, based on postmarket surveillance programs
and activities (including MedWatch), risk-benefit analyses,
adverse event reports, the scientific literature, and any
clinical or observational studies (including studies required
under subsection (d) or (e)), and any other resources that
the Director of the Center determines appropriate, whether a
drug or biological product may present an unreasonable risk
to the health of patients or the general public, and take
corrective action if such an unreasonable risk may exist;
``(F) make information about the safety and effectiveness
of approved drugs and licensed biological products available
to the public and healthcare providers in a timely manner;
and
``(G) conduct other activities as the Director of the
Center determines appropriate to ensure the safety and
effectiveness of all drugs approved under section 505 and all
biological products licensed under section 351 of the Public
Health Service Act.
``(2) Determination of unreasonable risk.--In determining
whether a drug or biological product may present an
unreasonable risk to the health of patients or the general
public, the Director of the Center, in consultation with the
Director of the Center for Drug Evaluation and Research or
the Director of the Center for Biologics Evaluation and
Research, as appropriate, shall consider the risk in relation
to the known benefits of such drug or biological product.
``(c) Secretarial Authority.--
``(1) In general.--Approval of a drug under section 505 of
this Act or issuance of a license for a biological product
under section 351 of the Public Health Service Act may be
subject to the requirement that the sponsor conduct 1 or more
postmarket studies as described in subsection (d) or (e) of
this section, or other postmarket studies as required by the
Secretary, to validate the safety and effectiveness of the
drug or biological product.
``(2) Definition.--For purposes of this section, the term
`postmarket' means--
``(A) with respect to a drug, after approval of an
application under section 505; and
``(B) with respect to a biological product, after licensure
under section 351 of the Public Health Service Act.
``(d) Preapproval Review.--
``(1) Review of application.--
``(A) In general.--
``(i) Review.--At any time before a drug is approved under
section 505 of this Act or a biological product is licensed
under section 351 of the Public Health Service Act, the
Director of the Center shall review the application (or
supplement to the application), and any analyses associated
with the application, of such drug or biological product.
``(ii) Effect of approval or licensure.--The approval of a
drug under section 505 or the licensure of a biological
product under such section 351 shall not affect the
continuation and completion of a review under clause (i).
``(B) Limitation.--In no case shall the review under
subparagraph (A) delay a decision with respect to an
application for a drug under section 505 of this Act or for a
biological product under section 351 of the Public Health
Service Act.
``(2) Result of review.--The Director of the Center may,
based on the review under paragraph (1)--
``(A) require that the sponsor of the application agree to
conduct 1 or more postmarket studies to determine the safety
or effectiveness of a drug or biological product, including
such safety or effectiveness as compared to other drugs or
biological products, to be completed by a date, and according
to the terms, specified by the Director of the Center; or
``(B) contract, or require the sponsor of the application
to contract, with a holder of a domestic or an international
patient database to conduct 1 or more epidemiologic or other
observational studies.
``(e) Postmarketing Studies of Drug Safety.--
``(1) In general.--At any time after a drug is approved
under section 505 of this Act or a biological product is
licensed under section 351 of the Public Health Service Act,
the Director of the Center, may--
``(A) require that the holder of an approved application or
license conduct 1 or more studies to determine the safety or
effectiveness of such drug or biological product, including
such safety and effectiveness as compared to other drugs or
biological products, to be completed by a date, and according
to the terms, specified by such Director; or
``(B) contract, or require the holder of the approved
application or license to contract, with a holder of a
domestic or an international patient database to conduct 1 or
more epidemiologic or other observational studies.
``(2) Review of outstanding studies.--Not later than 90
days after the date of enactment of the Food and Drug
Administration Safety Act of 2007, the Director of the Center
shall--
``(A) review and publish a list in the Federal Register of
any postmarketing studies outstanding on the date of
enactment of the Food and Drug Administration Safety Act of
2007; and
``(B) as the Director determines appropriate, require the
sponsor of a study described in subparagraph (A) to conduct
such study under this subsection.
``(f) Publication of Progress Reports and Completed
Studies.--
``(1) In general.--The Director of the Center shall require
that the sponsor of a study under subsection (d) or (e)
submit to the Secretary--
``(A) not less frequently than every 90 days, an up-to-date
report describing the progress of such study; and
``(B) upon the completion date of such study, the results
of such study.
``(2) Completion date.--For purposes of this section, the
completion date of such study shall be determined by the
Director of the Center.
``(g) Determinations by Director.--
``(1) Results of study.--The Director of the Center shall
determine, upon receipt of the results of a study required
under subsection (d) or (e)--
``(A) whether the drug or biological product studied may
present an unreasonable risk to the health of patients or the
general public; and
``(B) what, if any, corrective action under subsection (k)
shall be taken to protect patients and the public health.
``(2) Results of evidence.--The Director of the Center may,
at any time, based on the empirical evidence from postmarket
surveillance programs and activities (including MedWatch),
risk-benefit analyses, adverse event reports, the scientific
literature, any clinical or observational studies (including
studies required under subsection (d) or (e)), or any other
resources that the Director of the Center determines
appropriate--
``(A) make a determination that a drug or biological
product may present an unreasonable risk to the health of
patients or the general public; and
``(B) order a corrective action under subsection (k) be
taken to protect patients and the public health.
``(3) Required consultation and considerations.--Before
making a determination under paragraph (2), ordering a study
under subsection (d) or (e), or taking a corrective action
under subsection (k), the Director of the Center shall--
``(A) consult with the Director of the Center for Drug
Evaluation and Research or the Director of the Center for
Biologics Evaluation and Research, as appropriate; and
``(B) consider--
``(i) the benefit-to-risk profile of the drug or biological
product;
``(ii) the effect that a corrective action, or failure to
take corrective action, will have on the patient population
that relies on the drug or biological product; and
``(iii) the extent to which the drug or biological product
presents a meaningful therapeutic benefit as compared to
other available treatments.
``(h) Public Information.--Periodically, but not less often
than every 90 days, the Secretary shall make available to the
public, by publication in the Federal Register and posting on
an Internet website, the following information:
``(1) Studies required under subsection (d) or (e)
including--
``(A) the type of study;
``(B) the nature of the study;
``(C) the primary and secondary outcomes of the study;
``(D) the date the study was required under subsection (d)
or (e) or was agreed to by the sponsor;
``(E) the deadline for completion of the study; and
``(F) if the study has not been completed by the deadline
under subparagraph (E), a statement that explains why.
``(2) The periodic progress reports and results of
completed studies described under subsection (f).
``(3) Any determinations made by the Director of the Center
under subsection (g), including--
``(A) reasons for the determination, including factual
basis for such determination;
``(B) reference to supporting empirical data; and
``(C) an explanation that describes why contrary data is
insufficient.
``(i) Drug Advisory Committee.--The Drug Safety and Risk
Management Advisory Committee within the Center of the Food
and Drug Administration shall--
``(1) meet not less frequently than every 180 days; and
``(2) make recommendations to the Director of the Center
with respect to--
``(A) which drugs and biological products should be the
subject of a study under subsection (d) or (e);
``(B) the design and duration for studies under subsection
(d) or (e);
``(C) which drugs and biological products may present an
unreasonable risk to the health of patients or the general
public; and
``(D) appropriate corrective actions under subsection (k).
``(j) Penalties.--
``(1) In general.--If the Secretary determines, after
notice and opportunity for an informal hearing, that a
sponsor of a drug or biological product or other entity has
failed to complete a study required under subsection (d) or
(e) by the date or to the terms specified by the Secretary
under such subsection, the Secretary may order such sponsor
or other entity to--
``(A) complete the study in a specified time;

[[Page S5428]]

``(B) revise the study to comply with the terms specified
by the Secretary under subsection (d) or (e); or
``(C) pay a civil penalty.
``(2) Amount of penalties.--
``(A) In general.--The civil penalty ordered under
paragraph (1) shall be $250,000 for the first 30-day period
after the date specified by the Secretary that the study is
not completed, and shall double in amount for every 30-day
period thereafter that the study is not completed.
``(B) Limitation.--In no case shall a penalty under
subparagraph (A) exceed $2,000,000 for any 30-day period.
``(3) Notification of penalty.--The Secretary shall publish
in the Federal Register any civil penalty ordered under this
subsection.
``(k) Result of Determination.--
``(1) In general.--If the Director of the Center makes a
determination that a drug or biological product may present
an unreasonable risk to the health of patients or the general
public under subsection (g), such Director shall order a
corrective action, as described under paragraph (2).
``(2) Corrective actions.--The corrective action described
under subsection (g)--
``(A) may include--
``(i) requiring a change to the drug or biological product
label by a date specified by the Director of the Center;
``(ii) modifying the approved indication of the drug or
biological product to restrict use to certain patients;
``(iii) placing restriction on the distribution of the drug
or biological product to ensure safe use;
``(iv) requiring the sponsor of the drug or biological
product or license to establish a patient registry;
``(v) requiring patients to sign a consent form prior to
receiving a prescription of the drug or biological product;
``(vi) requiring the sponsor to monitor sales and usage of
the drug or biological product to detect unsafe use;
``(vii) requiring patient or physician education; and
``(viii) requiring the establishment of a risk management
plan by the sponsor; and
``(B) shall include the requirements with respect to
promotional material under subsection (l)(1).
``(3) Penalties.--
``(A) In general.--If the Secretary determines, after
notice and opportunity for an informal hearing, that a
sponsor of a drug or biological product has failed to take
the corrective action ordered by the Director of the Center
under this subsection or has failed to comply with subsection
(l)(2), the Secretary may order such sponsor to pay a civil
penalty.
``(B) Amount of penalties.--
``(i) In general.--The civil penalty ordered under
subparagraph (A) shall be $250,000 for the first 30-day
period that the sponsor does not comply with the order under
paragraph (1), and shall double in amount for every 30-day
period thereafter that the order is not complied with.
``(ii) Limitation.--In no case shall a penalty under clause
(i) exceed $2,000,000 for any 30-day period.
``(C) Notification of penalty.--The Secretary shall publish
in the Federal Register any civil penalty ordered under this
paragraph.
``(l) Promotion Material.--
``(1) Safety issue.--If the Director of the Center makes a
determination that a drug or biological product may present
an unreasonable risk to the health of patients or the general
public under subsection (g), such Director, in consultation
with the Division of Drug Marketing, Advertising, and
Communications of the Food and Drug Administration, shall--
``(A) notwithstanding section 502(n), require that the
sponsor of such drug or biological product submit to the
Director of the Center copies of all promotional material
with respect to the drug or biological product not less than
30 days prior to the dissemination of such material; and
``(B) require that all promotional material with respect to
the drug or biological product include certain disclosures,
which shall be displayed prominently and in a manner easily
understood by the general public, including--
``(i) a statement that describes the unreasonable risk to
the health of patients or the general public as determined by
the Director of the Center;
``(ii) a statement that encourages patients to discuss
potential risks and benefits with their healthcare provider;
``(iii) a description of the corrective actions required
under subsection (k);
``(iv) where appropriate, a statement explaining that there
may be products available to treat the same disease or
condition that present a more favorable benefit-to-risk
profile, and that patients should talk to their healthcare
provider about the risks and benefits of alternative
treatments;
``(v) a description of any requirements of outstanding
clinical and observational studies, including the purpose of
each study; and
``(vi) contact information to report a suspected adverse
reaction.
``(2) New products; outstanding studies.--For the first 2-
year period after a drug is approved under section 505 of
this Act or a biological product is licensed under section
351 of the Public Health Service Act, and with respect to
drugs and biological products for which there are outstanding
study requirements under subsection (d) or (e), the Director
of the Center, in consultation with the Division of Drug
Marketing, Advertising, and Communications of the Food and
Drug Administration, shall--
``(A) notwithstanding section 502(n), require that the
sponsor of such drug or biological product submit to the
Director of the Center copies of all promotional material
with respect to the drug or biological product not less than
30 days prior to the dissemination of such material; and
``(B) require that all promotional material with respect to
the drug or biological product include certain disclosures,
which shall be displayed prominently and in a manner easily
understood by the general public, including--
``(i) a statement explaining that the drug or biological
product is newly approved or licensed or the subject of
outstanding clinical or observational studies, as the case
may be, and, as a result, not all side effects or drug
interactions may be known;
``(ii) the number of people in which the drug or biological
product has been studied and the duration of time during
which the drug or biological product has been studied;
``(iii) a statement that encourages patients to discuss the
potential risks and benefits of treatment with their
healthcare provider;
``(iv) a description of any requirements of outstanding
clinical and observational studies, including the purpose of
each study; and
``(v) contact information to report a suspected adverse
reaction.
``(3) Effect of voluntary submission.--Paragraphs (1)(A)
and (2)(A) shall not apply to the sponsor of a drug or
biological product if such sponsor has voluntarily submitted
to the Division of Drug Marketing, Advertising, and
Communications of the Food and Drug Administration all
promotional material with respect to the drug or biological
product prior to the dissemination of such material.
``(m) Withdrawal or Suspension of Approval or Licensure.--
``(1) In general.--The Director of the Center, may withdraw
or suspend approval of a drug or licensure of a biological
product using expedited procedures (as prescribed by the
Secretary in regulations promulgated not later than 1 year
after the date of enactment of the Food and Drug
Administration Safety Act of 2007, which shall include an
opportunity for an informal hearing) after consultation with
the Director of the Center for Drug Evaluation and Research
or the Director of the Center for Biologics Evaluation and
Research, as appropriate, and any other person as determined
appropriate by the Director of the Center, if--
``(A) the Director of the Center makes a determination that
the drug or biological product may present an unreasonable
risk to the health of patients or the general public, and
that risk cannot be satisfactorily alleviated by a corrective
action under subsection (k); or
``(B) the sponsor fails to comply with an order or
requirement under this section.
``(2) Public information.--The Secretary shall make
available to the public, by publication in the Federal
Register and posting on an Internet website, the details of
the consultation described in paragraph (1), including--
``(A) the reason for the determination to withdraw,
suspend, or failure to withdraw or suspend, approval for the
drug or licensure for the biological product;
``(B) the factual basis for such determination;
``(C) reference to supporting empirical data;
``(D) an explanation that describes why contrary data is
insufficient; and
``(E) the position taken by each individual consulted.
``(n) Effect of Section.--The authorities conferred by this
section shall be separate from and in addition to the
authorities conferred by section 505B.
``(o) Administration of Section.--The provisions of this
section shall be carried out by the Secretary, acting through
the Director of the Center.''.
(b) Misbranding.--Section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352) is amended by inserting
after subsection (j) the following:
``(k) If it is a drug or biological product for which the
sponsor of an application or holder of an approved
application or license has not complied with an order or
requirement under section 507.''.
(c) Report on Devices.--Not later than 6 months after the
date of enactment of this Act, the Secretary of Health and
Human Services, in consultation with the Commissioner of Food
and Drugs, the Director of the Center for Postmarket
Evaluation and Research for Drugs and Biologics, and the
Director of the Center for Devices and Radiological Health,
shall submit to Congress a report that--
(1) identifies gaps in the current process of postmarket
surveillance of devices approved under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321 et seq.);
(2) includes recommendations on ways to improve gaps in
postmarket surveillance of devices; and
(3) identifies the changes in authority needed to make
those improvements, recognizing the legitimate differences
between devices and other medical products regulated by the
Food and Drug Administration.
(d) Transfer of Functions.--The functions and duties of the
Office of Surveillance and Epidemiology, including the Drug
Safety

[[Page S5429]]

and Risk Management Advisory Committee, of the Food and Drug
Administration on the day before the date of enactment of
this Act shall be transferred to the Center for Postmarket
Evaluation and Research for Drugs and Biologics established
under section 507 of the Federal Food, Drug, and Cosmetic Act
(as added by this section). The Center for Postmarket
Evaluation and Research for Drugs and Biologics shall be a
separate entity within the Food and Drug Administration and
shall not be an administrative office of the Center for Drug
Evaluation and Research or the Center for Biologics
Evaluation and Research.
(e) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section (and the
amendments made by this section)--
(1) $50,000,000 for fiscal year 2008;
(2) $75,000,000 for fiscal year 2009;
(3) $100,000,000 for fiscal year 2010;
(4) $125,000,000 for fiscal year 2011; and
(5) $150,000,000 for fiscal year 2012.
______

SA 995. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the end of subtitle E of title II, insert the following:

SEC. 2_. AUTHORITY OF THE OFFICE OF SURVEILLANCE AND
EPIDEMIOLOGY; CHIEF SAFETY OFFICER.

(a) Authority.--With respect to all actions of the Food and
Drug Administration related to postmarketing drug safety,
including labeling changes, postapproval studies, and
restrictions on distribution or use of drugs with serious
risks, the Office of Surveillance and Epidemiology (or
successor office) of such Administration and the Office of
New Drugs (or successor office) of such Administration shall
make decisions jointly. In the event of a disagreement with
respect to an action related to postmarketing drug safety,
including labeling changes, postapproval studies, and
restrictions on distribution or use of drugs with serious
risks, between such 2 offices, the Commissioner of Food and
Drugs shall make the decision with respect to such action.
(b) Chief Safety Officer.--Notwithstanding any other
provision of law, the Director of the Office of Surveillance
and Epidemiology (or successor office) of the Food and Drug
Administration shall serve as the Chief Postmarket Drug
Safety Officer within the Food and Drug Administration. In
such capacity, the Director shall serve as a liaison between
the Office of the Commissioner of Food and Drugs and
employees of the Food and Drug Administration. To ensure drug
safety concerns are identified and promptly evaluated and
resolved, any employee of the Center for Drug Evaluation and
Research within the Food and Drug Administration who has drug
safety concerns may report such concerns to the Chief
Postmarket Drug Safety Officer.
______

SA 996. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the end of section 505 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 251 of the bill, add the
following:
``(r) Certification of Information.--When submitting
information in support of a new drug application or a
supplemental new drug application, the sponsor shall certify,
in writing, that all clinical trials, federally or privately
funded, whether conducted within or outside the United
States, related to the safety or efficacy of the drug under
review, have been submitted to the Food and Drug
Administration.''.
______

SA 997. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

Strike clause (i) of section 402(j)(3)(A) of the Public
Health Service Act, as added by this bill, and insert the
following:
``(i) In general.--

``(I) Requirement.--Not later than 90 days after the date
of enactment of the Food and Drug Administration
Revitalization Act, for all clinical trials (except as
provided in subclause (II)), whether federally or privately
funded, conducted to test the safety or efficacy (including
comparative efficacy), of any drug or device (including those
drugs or devices approved or cleared by the Secretary), the
Secretary shall ensure that the registry data bank includes
links to results information for such clinical trial--

``(aa) not earlier than 30 days after the date of the
approval of the drug involved or clearance or approval of the
device involved; or
``(bb) not later than 30 days after such information
becomes publicly available, as applicable.

``(II) Exception.--The requirement of subclause (I) shall
not apply to phase I clinical investigations conducted to
test solely the safety of an unapproved drug or unlicensed
biological product, or pilot or feasibility studies conducted
to confirm the design and operating specifications of an
unapproved or not yet cleared medical device.
``(III) Voluntary submission.--A responsible party for a
clinical trial that is not an applicable drug clinical trial
or an applicable device clinical trial may submit to the
Secretary results information for a clinical trial described
in subclause (II).

At the end section 402(j)(4) of the Public Health Service
Act, as added by this bill, insert the following:
``(F) Trials conducted outside of the united states.--
``(i) In general.--With respect to clinical trials
described in clause (ii), the responsible party shall submit
to the Secretary the information required under this
subsection. The Secretary shall ensure that such information
and the results of such clinical trials are made available to
the public in a timely manner and as soon as practicable
after receiving such information. Failure to comply with this
paragraph shall be deemed to be a failure to submit
information as required under this subsection, and the
appropriate remedies and sanctions under this section shall
apply.
``(ii) Clinical trial described.--A clinical trial is
described in this clause if--

``(I) such trial is conducted outside of the United States;
and
``(II) the data from such trial is--

``(aa) submitted to the Secretary as part of an
application, including a supplemental application, for a drug
or device under section 505, 510, 515, or 520 of the Federal
Food, Drug, and Cosmetic Act or for the biological product
under section 351 of this Act; or
``(bb) used in advertising or labeling to make a claim
about the drug or device involved.
______

SA 998. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the appropriate place in section 505(o) of the Federal,
Food, Drug, and Cosmetic, as added by section 202, insert the
following:
``(9) Civil monetary penalty.--Notwithstanding any other
provision of this Act, an applicant (as such term is defined
for purposes of this section) that knowingly fails to comply
with a requirement of an approved risk evaluation and
mitigation strategy under this subsection shall be subject to
a civil money penalty of $250,000 for the first 30-day period
that the applicant is in noncompliance, and such amount shall
double for every 30-day period thereafter that the
requirement is not complied with, not to exceed
$2,000,000.''.
______

SA 999. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the end of section 505 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 251 of the bill, add the
following:
``(r) Certification of Information.--
``(1) Certification.--
``(A) Requirement.--When submitting information in support
of a new drug application or a supplemental new drug
application, the sponsor shall certify, in writing, that the
information submitted to the Food and Drug Administration
complies with the requirements of this Act and that such
information is not false or misleading.
``(B) Failure to submit.--If the sponsor fails to provide a
certification as required under subparagraph (A), the
Secretary shall transmit to such sponsor a notice stating
that such sponsor shall submit the certification by a date
determined by the Secretary. If, by the date specified by the
Secretary in the notice under this subparagraph, the
Secretary has not received the certification, the Secretary,
after providing the opportunity for a hearing, shall order
such sponsor to pay a civil monetary penalty of $10,000 for
each day after such date that such certification is not
submitted.
``(C) Additional civil monetary penalty.--If the Secretary
determines, after notice and opportunity for a hearing, that
a sponsor knew or should have known that the information
submitted in support of a new drug application or a
supplemental new drug application was false or inaccurate,
the Secretary shall order such sponsor to pay a civil
monetary penalty of not less than $100,000, but not to exceed
$2,000,000.
``(2) Required statement.--The certification under
paragraph (1) shall include a statement that all clinical
trials, federally or privately funded, whether conducted
within or outside the United States, related to the safety or
efficacy of the drug under review, have been submitted to the
Food and Drug Administration.
``(3) Clinical comparison studies.--
``(A) In general.--The Secretary shall deposit funds
collected under paragraph (1)

[[Page S5430]]

into an account and use such funds shall be used, after
consultation with the Director of the Agency for Healthcare
Research and Quality, to fund studies that compare the
clinical effectiveness of 2 or more treatments for similar
diseases or conditions.
``(B) Priority list.--The Secretary shall award funding
under subparagraph (A) based on a priority list established,
not later than 6 months after the date of enactment of this
Act, by the Director of the Agency for Healthcare Research
and Quality and periodically updated as determined
appropriate by the Director.
``(4) Drug consultations.--Not later than 90 days after the
date of the completion of a written consultation on a drug
concerning the drug's safety, as conducted by the Office of
Surveillance and Epidemiology, regardless of whether such
consultation was initiated by such Office or by an entity
outside of the Office, the Commissioner of Food and Drugs
shall make available to the public a full copy of such
consultation.
``(5) Rule of construction.--Nothing in this subsection
shall be construed to alter or amend section 301(j) of this
Act or section 1905 of title 18, United States Code.''.
______

SA 1000. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the appropriate place, insert the following:

TITLE__FDA EMPLOYEE PROTECTIONS

SEC. __01. SHORT TITLE.

This title may be cited as the ``FDA Employee Rights
Protection Act''.

SEC. __02. EMPLOYEES' RIGHT TO PETITION CONGRESS.

The right of all employees of the Food and Drug
Administration, individually or collectively, to petition
Congress or a Member of Congress, or to furnish information
to either House of Congress, or to a committee or Member
thereof, shall not be interfered with or denied by any
employee of the Food and Drug Administration, the Department
of Health and Human Services, the Department of Justice, or
any other employee of the Executive Branch of the Federal
Government.

SEC. _03. PENALTIES.

Any individual who intentionally or willfully obstructs,
impedes, or otherwise interferes with an employee's right to
furnish information as described in section __02 shall be
subject to a fine of not less than $10,000 per violation, or
imprisoned for not more than 1 year, or both.
______

SA 1001. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the appropriate place, insert the following:

SEC. __. SUBPOENA AUTHORITY OF THE COMMISSIONER OF FOOD AND
DRUGS.

(a) In General.--Section 310 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 337) is amended by adding at the end
the following:
``(c) For the purpose of--
``(1) any hearing, investigation, or other proceeding
respecting a violation of this Act,
``(2) any hearing, investigation, or other proceeding to
determine if a person is in compliance with a standard or
other requirement under this Act, or
``(3) any hearing, investigation, or other proceeding to
establish a standard or other requirement under this Act,
the Commissioner may issue subpoenas requiring the attendance
and testimony of witnesses and the production of documentary
evidence. Such attendance of witnesses and production of
evidence at the designated place of such hearing,
investigation, or other proceeding may be required from any
place in the United States or in any territory or possession
of the United States. Subpoenas of the Commissioner shall be
served by a person authorized by the Commissioner by
delivering a copy thereof to the person named therein or by
certified mail addressed to such person at such person's last
known dwelling place or principal place of business. A
verified return by the person so serving the subpoena setting
forth the manner of service, or, in the case of service by
certified mail, the return post office receipt therefor
signed by the person so served, shall be proof of service.
Witnesses so subpoenaed shall be paid the same fees and
mileage as are paid witnesses in the district courts of the
United States.
``(d) In case of a refusal to obey a subpoena duly served
upon any person under subsection (c), any district court of
the United States for the judicial district in which such
person charged with refusal to obey is found, resides, or
transacts business, upon application by the Commissioner,
shall have jurisdiction to issue an order requiring such
person to appear and give testimony or to appear and produce
evidence, or both. The failure to obey such order of the
court may be punished by the court as contempt thereof.''.
(b) Enforcement.--Section 301 (21 U.S.C. 331) is amended by
adding at the end the following:
``(jj) The failure or refusal to obey a subpoena issued by
the Commissioner under section 310(c).''.
______

SA 1002. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the appropriate place, insert the following:

SEC. __. REQUIREMENT TO DOCUMENT CONTACT WITH DRUG SPONSORS.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as amended by section 251, is further amended by
adding at the end the following:
``(r) Requirement to Document Contact With Drug Sponsor.--
Each employee of the Food and Drug Administration shall
document, in writing, each communication or contact, and the
purpose of such communication or contact, that such official
has with a sponsor of a drug for which an application is
filled pursuant to subsection (b) or (j).''.
______

SA 1003. Mr. GRASSLEY submitted an amendment intended to be proposed
by him to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

After section 211 of the bill, insert the following:

SEC. 211A. REQUIREMENT TO SUBMIT INFORMATION ELECTRONICALLY.

Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.), as amended by this
Act, is further amended by adding at the end the following:

``SEC. 567. REQUIREMENT TO SUBMIT INFORMATION ELECTRONICALLY.

``Not later than 5 years after the date of enactment of the
Food and Drug Administration Revitalization Act, the
Secretary shall ensure that any information required to be
submitted to the Food and Drug Administration under section
505, 505A, 505B, 506A, 506B, 510, 512, 513, 515, 519, 520, or
526 is submitted in electronic form that is interoperable
with the Food and Drug Administration's information
technology systems.''.
______

SA 1004. Ms. LANDRIEU proposed an amendment to the bill S. 1082, to
amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend
the prescription drug user fee provisions, and for other purposes; as
follows:

At the end of the bill, add the following:

TITLE__DOMESTIC PET TURTLE MARKET ACCESS

SEC. __. SHORT TITLE.

This title may be cited as the ``Domestic Pet Turtle Market
Access Act of 2007''.

SEC. __. FINDINGS.

Congress makes the following findings:
(1) Pet turtles less than 10.2 centimeters in diameter have
been banned for sale in the United States by the Food and
Drug Administration since 1975 due to health concerns.
(2) The Food and Drug Administration does not ban the sale
of iguanas or other lizards, snakes, frogs, or other
amphibians or reptiles that are sold as pets in the United
States that also carry salmonella bacteria. The Food and Drug
Administration also does not require that these animals be
treated for salmonella bacteria before being sold as pets.
(3) The technology to treat turtles for salmonella, and
make them safe for sale, has greatly advanced since 1975.
Treatments exist that can nearly eradicate salmonella from
turtles, and individuals are more aware of the causes of
salmonella, how to treat salmonella poisoning, and the
seriousness associated with salmonella poisoning.
(4) University research has shown that these turtles can be
treated in such a way that they can be raised, shipped, and
distributed without having a recolonization of salmonella.
(5) University research has also shown that pet owners can
be equipped with a treatment regiment that allows the turtle
to be maintained safe from salmonella.
(6) The Food and Drug Administration should allow the sale
of turtles less than 10.2 centimeters in diameter as pets as
long as the sellers are required to use proven methods to
treat these turtles for salmonella.

SEC. __. SALE OF BABY TURTLES.

(a) Notwithstanding any other provision of law, the Food
and Drug Administration shall not restrict the sale by a
turtle farmer, wholesaler or commercial retail seller of a
turtle that is less than 10.2 centimeters in diameter as a
pet if--
(1) the State or territory in which such farmer is located
has developed a regulatory process by which pet turtle
farmers are required to have a State license to breed, hatch,
propagate, raise, grow, receive, ship, transport, export, or
sell pet turtles or pet turtle eggs;

[[Page S5431]]

(2) such State or territory requires certification of
sanitization that is signed by a veterinarian who is licensed
in the State or territory, and approved by the State or
territory agency in charge of regulating the sale of pet
turtles;
(3) the certification of sanitization requires each turtle
to be sanitized or treated for diseases, including
salmonella, and is dependant upon using the Siebeling method,
or other such proven method, which uses an antibiotic to make
the turtle salmonella-free; and
(4) the turtle farmer or commercial retail seller includes,
with the sale of such a turtle, a disclosure to the buyer
that includes--
(A) information regarding--
(i) the possibility that salmonella can re-colonize in
turtles;
(ii) the dangers, including possible severe illness or
death, especially for at-risk people who may be susceptible
to salmonella poisoning, such as children, pregnant women,
and others who may have weak immune systems, that could
result if the turtle is not properly handled and safely
maintained;
(iii) the proper handling of the turtle, including an
explanation of proper hygiene such as handwashing after
handling a turtle; and
(iv) the proven methods of treatment that, if properly
applied, keep the turtle safe from salmonella;
(B) a detailed explanation of how to properly treat the
turtle to keep it safe from salmonella, using the proven
methods of treatment referred to under subparagraph (A), and
how the buyer can continue to purchase the tools, treatments,
or any other required item to continually treat the turtle;
and
(C) a statement that buyers of pet turtles should not
abandon the turtle or abandon it outside, as the turtle may
become an invasive species to the local community, but should
instead return them to a commercial retail pet seller or
other organization that would accept turtles no longer wanted
as pets.
(b) FDA Review of State Protections.--The Food and Drug
Administration may, after providing an opportunity for the
affected State to respond, restrict the sale of a turtle only
if the Secretary of Health and Human Services determines that
the actual implementation of State health protections
described in subsection (a) are insufficient to protect
consumers against infectious diseases acquired from such
turtles at the time of sale.
______

SA 1005. Mr. LEVIN submitted an amendment intended to be proposed by
him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic
Act to reauthorize and amend the prescription drug user fee provisions,
and for other purposes; which was ordered to lie on the table; as
follows:

At the appropriate place, insert the following:

SEC. __. SAFETY OF FOOD ADDITIVES.

Not later than 90 days after the date of enactment of this
Act, the Food and Drug Administration shall issue a report on
the question of whether substances used in fresh meat that
are capable of artificially keeping such meat red beyond the
point of spoilage of such meat, create a health risk or are
misleading to consumers.
______

SA 1006. Ms. MURKOWSKI submitted an amendment intended to be proposed
by her to the bill S. 1082, to amend the Federal Food, Drug, and
Cosmetic Act to reauthorize and amend the prescription drug user fee
provisions, and for other purposes; which was ordered to lie on the
table; as follows:

At the end of section 505(o)(6) of the Federal Food, Drug,
and Cosmetic Act, as added by section 202 of the bill, insert
the following:
``(H) In a case where a drug may be prescribed only by a
physician with particular training or experience, or who is
specially certified, a health care provider who is not so
certified or trained to prescribe the drug may enter into a
cooperation plan with a physician who has particular training
or experience, or is specially certified, in order to
prescribe such drug with the informed consent of the patient.
The Commissioner of Food and Drugs shall determine the
requirements for such cooperation plan.
______

SA 1007. Mr. REID (for Mr. Bunning) proposed an amendment to the
resolution S. Res. 162, commemorating and acknowledging the dedication
and sacrifice made by the men and women who have lost their lives while
serving as law enforcement officers; as follows:

On page 2, strike the first whereas clause and insert:
Whereas peace officers are on the front lines in protecting
the schools and schoolchildren of the United States;

____________________