S.Amdt. 2863

SA 2863. Mr. VITTER submitted an amendment intended to be proposed to
amendment SA 2786 proposed by Mr. Reid (for himself, Mr. Baucus, Mr.
Dodd, and Mr. Harkin) to the bill H.R. 3590, to amend the Internal
Revenue Code of 1986 to modify the first-time homebuyers credit in the
case of members of the Armed Forces and certain other Federal
employees, and for other

[[Page S12337]]

purposes; which was ordered to lie on the table; as follows:

At the end, add the following:

TITLE X--IMPORTATION OF PRESCRIPTION DRUGS

SEC. 10001. SHORT TITLE.

This title may be cited as the ``Pharmaceutical Market
Access Act of 2009''

SEC. 10002. 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; and
(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. 10003. 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 Web site.
``(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 2009,
the Secretary, after consultation with the United States
Trade Representative and the Commissioner of the U.S. 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
(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 505E 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 Web 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.

[[Page S12338]]

``(4) Education of consumers.--The Secretary shall carry
out activities, by use of the Internet Web site 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 2009,
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. 10004. REGISTRATION FEES.

Subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at
the end the following:

``PART 6--FEES RELATING TO PRESCRIPTION DRUG IMPORTATION

``SEC. 743. 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 2009 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 2009, 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, 2009, 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 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 2009, 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. 10005. 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:
``(aa) If it is a drug subject to section 503(b), unless
the packaging of such drug complies with the requirements of
section 505E 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 505D the following:

``SEC. 505E. 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

[[Page S12339]]

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 2009.''.

SEC. 10006. 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. 10007. 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 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384) that
was first sold abroad by or under authority of the owner or
licensee of such patent.''.

SEC. 10008. OTHER ENFORCEMENT ACTIONS.

(a) In General.--Section 804 of the Federal Food, Drug, and
Cosmetic Act, as amended by section 10003, 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, 2009, 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)(F) 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--
``(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 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),

[[Page S12340]]

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 2009 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 (21 U.S.C.
384(g)), as amended by section 10003(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.''.

SEC. 10009. 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).
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