FACT Act
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1798-1803)
February 28, 2005
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Sponsor introductory remarks on measure. (CR S538-539)
January 26, 2005
Introduced in Senate
February 28, 2005
Sponsor introductory remarks on measure. (CR S1797-1798)
February 28, 2005
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1798-1803)
February 28, 2005
Floor Debate
14 membersWhat members said about S. 470 on the floor




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Floor Debate
14 membersWhat members said about S. 470 on the floor
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Mr. President, I rise today to introduce the Fair Access to Clinical Trials, FACT, Act. I want to begin by thanking Senator Grassley, Senator Johnson, and Senator Wyden for joining me in introducing…
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Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. It is my understanding of the parliamentary situation that an amendment by the distinguished Senator from West…
Mr. President, earlier today, Senate Bill 470 was introduced. I am pleased to sponsor the Fair Access to Clinical Trials Act of 2005, with Senator Dodd. I am co-sponsoring this legislation as part of…
Mr. President, earlier today, Senate Bill 470 was introduced. I am pleased to sponsor the Fair Access to Clinical Trials Act of 2005, with Senator Dodd. I am co-sponsoring this legislation as part of…
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Mr. President, I am very pleased to join in cosponsoring this amendment. I thank the Chairman and the ranking member of the Appropriations Committee for bringing this amendment forward. It is an…
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Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, without interfering with the orderly business of the Senate, I ask unanimous consent to speak as…
Bill Text
Latest available legislative text
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 470 Introduced in Senate (IS)]
109th CONGRESS
1st Session
S. 470
To amend the Public Health Service Act to expand the clinical trials
drug data bank.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 28, 2005
Mr. Dodd (for himself, Mr. Grassley, Mr. Johnson, and Mr. Wyden)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to expand the clinical trials
drug data bank.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Fair Access to Clinical Trials Act
of 2005'' or the ``FACT Act''.
SEC. 2. PURPOSE.
It is the purpose of this Act--
(1) to create a publicly accessible national data bank of
clinical trial information comprised of a clinical trial
registry and a clinical trial results database;
(2) to foster transparency and accountability in health-
related intervention research and development;
(3) to maintain a clinical trial registry accessible to
patients and health care practitioners seeking information
related to ongoing clinical trials for serious or life-
threatening diseases and conditions; and
(4) to establish a clinical trials results database of all
publicly and privately funded clinical trial results regardless
of outcome, that is accessible to the scientific community,
health care practitioners, and members of the public.
SEC. 3. CLINICAL TRIALS DATA BANK.
(a) In General.--Section 402(j) of the Public Health Service Act
(42 U.S.C. 282(j)) is amended--
(1) in paragraph (1)(A), by striking ``for drugs for
serious or life-threatening diseases and conditions'';
(2) in paragraph (2), by striking ``available to
individuals with serious'' and all that follows through the
period and inserting ``accessible to patients, other members of
the public, health care practitioners, researchers and the
scientific community. In making information about clinical
trials publicly available, the Secretary shall seek to be as
timely and transparent as possible.'';
(3) by redesignating paragraphs (4) and (5), as paragraphs
(8) and (9), respectively;
(4) by striking paragraph (3) and inserting the following:
``(3) The data bank shall include the following:
``(A)(i) A registry of clinical trials (in this
subparagraph referred to as the `registry') of health-related
interventions (whether federally or privately funded).
``(ii) The registry shall include information for all
clinical trials conducted to test the safety or effectiveness
(including comparative effectiveness) of any drug, biological
product, or device (including those drugs, biological products,
or devices approved or cleared by the Secretary) intended to
treat serious or life-threatening diseases and conditions,
except those Phase I clinical trials 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. For purposes of this section, Phase
I clinical trials are trials described in section 313.12(a) of
title 21, Code of Federal Regulations (or any successor
regulations).
``(iii) The registry may include information for--
``(I) Phase I clinical trials 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 with the consent of the responsible
person; and
``(II) clinical trials of other health-related
interventions with the consent of the responsible
person.
``(iv) The information to be included in the registry under
this subparagraph shall include the following:
``(I) Descriptive information, including a brief
title, trial description in lay terminology, trial
phase, trial type, trial purpose, description of the
primary and secondary clinical outcome measures to be
examined in the trial, the time at which the outcome
measures will be assessed, and the dates and details of
any revisions to such outcomes.
``(II) Recruitment information, including
eligibility and exclusion criteria, a description of
whether, and through what procedure, the manufacturer
or sponsor of the investigation of a new drug will
respond to requests for protocol exception, with
appropriate safeguards, for single-patient and expanded
protocol use of the new drug, particularly in children,
a statement as to whether the trial is closed to
enrollment of new patients, overall trial status,
individual site status, and estimated completion date.
For purposes of this section the term `completion date'
means the date of the last visit by subjects in the
trial for the outcomes described in subclause (I).
``(III) Location and contact information, including
the identity of the responsible person.
``(IV) Administrative data, including the study
sponsor and the study funding source.
``(V) Information pertaining to experimental
treatments for serious or life threatening diseases and
conditions (whether federally or privately funded) that
may be available--
``(aa) under a treatment investigational
new drug application that has been submitted to
the Secretary under section 360bbb(c) of title 21, Code of Federal
Regulations; or
``(bb) as a Group C cancer drug (as defined
by the National Cancer Institute).
``(B)(i) A clinical trials results database (in this
subparagraph referred to as the `database') of health-related
interventions (whether federally or privately funded).
``(ii) The database shall include information for all
clinical trials conducted to test the safety or effectiveness
(including comparative effectiveness) of any drug, biological
product, or device (including those drugs, biological products,
or devices approved or cleared by the Secretary), except those
Phase I clinical trials 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) The database may include information for--
``(I) Phase I clinical trials 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 with the consent of the responsible
person; and
``(II) clinical trials of other health-related
interventions with the consent of the responsible
person.
``(iv) The information to be included in the database under
this subparagraph shall include the following:
``(I) Descriptive information, including--
``(aa) a brief title;
``(bb) the drug, biological product or
device to be tested;
``(cc) a trial description in lay
terminology;
``(dd) the trial phase;
``(ee) the trial type;
``(ff) the trial purpose;
``(gg) the estimated completion date for
the trial; and
``(hh) the study sponsor and the study
funding source.
``(II) A description of the primary and secondary
clinical outcome measures to be examined in the trial,
the time at which the outcome measures will be
assessed, and the dates and details of any revisions to
such outcomes.
``(III) The actual completion date of the trial and
the reasons for any difference from such actual date
and the estimated completion date submitted pursuant to
subclause (I)(hh). If the trial is not completed, the
termination date and reasons for such termination.
``(IV) A summary of the results of the trial in a
standard, non-promotional summary format (such as ICHE3
template form), including the trial design and
methodology, results of the primary and secondary
outcome measures as described in subclause (II),
summary data tables with respect to the primary and
secondary outcome measures, including information on
the statistical significance or lack thereof of such
results.
``(V) Safety data concerning the trial (including a
summary of all adverse events specifying the number and
type of such events, data on prespecified adverse
events, data on serious adverse events, and data on
overall deaths).
``(VI) Any publications in peer reviewed journals
relating to the trial. If the trial results are
published in a peer reviewed journal, the database
shall include a citation to and, when available, a link
to the journal article.
``(VII) A description of the process used to review
the results of the trial, including a statement about
whether the results have been peer reviewed by
reviewers independent of the trial sponsor.
``(VIII) If the trial addresses the safety,
effectiveness, or benefit of a use not described in the
approved labeling for the drug, biological product, or
device, a statement, as appropriate, displayed
prominently at the beginning of the data in the
registry with respect to the trial, that the Food and
Drug Administration--
``(aa) is currently reviewing an
application for approval of such use to
determine whether the use is safe and
effective;
``(bb) has disapproved an application for
approval of such use;
``(cc) has reviewed an application for
approval of such use but the application was
withdrawn prior to approval or disapproval; or
``(dd) has not reviewed or approved such
use as safe and effective.
``(IX) If data from the trial has not been
submitted to the Food and Drug Administration, an
explanation of why it has not been submitted.
``(X) A description of the protocol used in such
trial to the extent necessary to evaluate the results
of such trial.
``(4)(A) Not later than 90 days after the date of the completion of
the review by the Food and Drug Administration of information submitted
by a sponsor in support of a new drug application, or a supplemental
new drug application, whether or not approved by the Food and Drug
Administration, the Commissioner of Food and Drugs shall make available
to the public the full reviews conducted by the Administration of such
application.
``(B) Not later than 90 days after the date of the completion of a
written consultation on a drug concerning the drug's safety conducted
by the Office of Drug Safety, regardless of whether initiated by such
Office or outside of the Office, the Commissioner of Food and Drugs
shall make available to the public a copy of such consultation in full.
``(C) Nothing in this paragraph shall be construed to alter or
amend section 301(j) or section 1905 of title 18, United States Code.
``(D) This paragraph shall supersede section 552 of title 5, United
States Code.
``(5) The information described in subparagraphs (A) and (B) of
paragraph (3) shall be in a format that can be readily accessed and
understood by members of the general public, including patients seeking
to enroll as subjects in clinical trials.
``(6) The Secretary shall assign each clinical trial a unique
identifier to be included in the registry and in the database described
in subparagraphs (A) and (B) of paragraph (3). To the extent
practicable, this identifier shall be consistent with other
internationally recognized and used identifiers.
``(7) To the extent practicable, the Secretary shall ensure that
where the same information is required for the registry and the
database described in subparagraphs (A) and (B) of paragraph (3), a
process exists to allow the responsible person to make only one
submission.''; and
(5) by adding at the end the following:
``(10) In this section, the term `clinical trial' with respect to
the registry and the database described in subparagraphs (A) and (B) of
paragraph (3) means a research study in human volunteers to answer
specific health questions, including treatment trials, prevention
trials, diagnostic trials, screening trials, and quality of life
trials.''.
(b) Actions of Secretary Regarding Clinical Trials.--Section 402 of
the Public Health Service Act (42 U.S.C. 282) is amended--
(1) by redesignating subsections (k) and (l) as subsections
(q) and (r), respectively; and
(2) by inserting after subsection (j), the following:
``(k) Federally Supported Trials.--
``(1) All federally supported trials.--With respect to any
clinical trial described in subsection (j)(3)(B) that is
supported solely by a grant, contract, or cooperative agreement
awarded by the Secretary, the principal investigator of such
trial shall, not later than the date specified in paragraph
(2), submit to the Secretary--
``(A) the information described in subclauses (II)
through (X) of subsection (j)(3)(B)(iv), and with
respect to clinical trials in progress on the date of
enactment of the FACT Act, the information described in
subclause (I) of subsection (j)(3)(B)(iv); or
``(B) a statement containing information sufficient
to demonstrate to the Secretary that the information
described in subparagraph (A) cannot reasonably be
submitted, along with an estimated date of submission
of the information described in such subparagraph.
``(2) Date specified.--The date specified in this paragraph
shall be the date that is 1 year from the earlier of--
``(A) the estimated completion date of the trial,
as submitted under subsection (j)(3)(B)(vi)(I)(hh); or
``(B) the actual date of the completion or
termination of the trial.
``(3) Condition of federal grants, contracts, and
cooperative agreements.--
``(A) Certification of compliance.--To be eligible
to receive a grant, contract, or cooperative agreement
from the Secretary for the conduct or support of a
clinical trial described in subsection (j)(3)(B), the
principal investigator involved shall certify to the
Secretary that--
``(i) such investigator shall submit data
to the Secretary in accordance with this
subsection; and
``(ii) such investigator has complied with
the requirements of this subsection with
respect to other clinical trials conducted by
such investigator after the date of enactment
of the FACT Act.
``(B) Failure to submit certification.--An
investigator that fails to submit a certification as
required under subparagraph (A) shall not be eligible
to receive a grant, contract, or cooperative agreement
from the Secretary for the conduct or support of a
clinical trial described in subsection (j)(3)(B).
``(C) Failure to comply with certification.--If, by
the date specified in paragraph (2), the Secretary has
not received the information or statement described in
paragraph (1), the Secretary shall--
``(i) transmit to the principal
investigator involved a notice specifying the
information or statement required to be
submitted to the Secretary and stating that
such investigator shall not be eligible to
receive further funding from the Secretary if
such information or statement is not submitted
to the Secretary within 30 days of the date on
which such notice is transmitted; and
``(ii) include and prominently display,
until such time as the Secretary receives the
information or statement described in paragraph
(1), as part of the record of such trial in the
database described in subsection (j), a notice
stating that the results of such trials have
not been reported as required by law.
``(D) Failure to comply with notice.--If by the
date that is 30 days after the date on which the notice
described in subparagraph (C) is transmitted, the
Secretary has not received from the principal
investigator involved the information or statement
required pursuant to such notice, the Secretary may not
award a grant, contract, cooperative agreement, or any
other award to such principal investigator until such
principal investigator submits to the Secretary the
information or statement required pursuant to such
notice.
``(E) Submission of statement but not
information.--
``(i) In general.--If by the date specified
in paragraph (2), the Secretary has received a
statement described in paragraph (1)(B) but not
the information described in paragraph (1)(A),
the Secretary shall transmit to the principal
investigator involved a notice stating that
such investigator shall submit such information
by the date determined by the Secretary in
consultation with such investigator.
``(ii) Failure to comply with
certification.--If, by the date specified by
the Secretary in the notice under clause (i),
the Secretary has not received the information
described in paragraph (1)(B), the Secretary
shall--
``(I) transmit to the principal
investigator involved a notice
specifying the information required to
be submitted to the Secretary and
stating that such investigator shall
not be eligible to receive further
funding from the Secretary if such
information is not submitted to the
Secretary within 30 days of the date on
which such notice is transmitted; and
``(II) include and prominently
display, until such time as the
Secretary receives the information
described in paragraph (1)(B), as part
of the record of such trial in the
database described in subsection (j), a
notice stating that the results of such
trials have not been reported as
required by law.
``(F) Failure to comply with notice.--If by the
date that is 30 days after the date on which the notice
described in subparagraph (E)(ii)(I) is transmitted,
the Secretary has not received from the principal
investigator involved the information required pursuant
to such notice, the Secretary may not award a grant,
contract, cooperative agreement, or any other award to
such principal investigator until such principal
investigator submits to the Secretary the information
required pursuant to such notice.
``(G) Rule of construction.--For purposes of this
paragraph, limitations on the awarding of grants,
contracts, cooperative agreements, or any other awards
to principal investigators for violations of this
paragraph shall not be construed to include any funding
that supports the clinical trial involved.
``(4) Rule of construction.--Nothing in this subsection
shall be construed to prevent an investigator other than the
investigator described in paragraph (3)(F) from receiving an
ongoing award, contract, or cooperative agreement.
``(5) Inclusion in registry.--
``(A) General rule.--The Secretary shall, pursuant
to subsection (j)(5), include--
``(i) the data described in subsection
(j)(3)(A) and submitted under the amendments
made by section 4(a) of the FACT Act in the
registry described in subsection (j) as soon as
practicable after receiving such data; and
``(ii) the data described in clause (I) of
subsection (j)(3)(B)(iv) and submitted under
this subsection or the amendments made by
section 4(a) of the FACT Act in the database
described in subsection (j) as soon as
practicable after receiving such data.
``(B) Other data.--
``(i) In general.--The Secretary shall,
pursuant to subsection (j)(5), include the data
described in subclauses (II) through (X) of
subsection (j)(3)(B)(iv) and submitted under
this section in the database described in
subsection (j)--
``(I) as soon as practicable after
receiving such data; or
``(II) in the case of data to which
clause (ii) applies, by the date
described in clause (iii).
``(ii) Data described.--This clause applies
to data described in clause (i) if--
``(I) the principal investigator
involved requests a delay in the
inclusion in the database of such data
in order to have such data published in
a peer reviewed journal; and
``(II) the Secretary determines
that an attempt will be made to seek
such publication.
``(iii) Date for inclusion in registry.--
Subject to clause (iv), the date described in
this clause is the earlier of--
``(I) the date on which the data
involved is published as provided for
in clause (ii); or
``(II) the date that is 18 months
after the date on which such data is
submitted to the Secretary.
``(iv) Extension of date.--The Secretary
may extend the 18-month period described in
clause (iii)(II) for an additional 6 months if
the principal investigator demonstrates to the
Secretary, prior to the expiration of such 18-
month period, that the data involved has been
accepted for publication by a journal described
in clause (ii)(I).
``(v) Modification of data.--Prior to
including data in the database under clause
(ii) or (iv), the Secretary shall permit the
principal investigator to modify the data
involved.
``(6) Memorandum of understanding.--Not later than 6 months
after the date of enactment of the FACT Act, the Secretary
shall seek a memorandum of understanding with the heads of all other
Federal agencies that conduct clinical trials to include in the
registry and the database clinical trials sponsored by such agencies
that meet the requirements of this subsection.
``(7) Application to certain persons.--The provisions of
this subsection shall apply to a responsible person described
in subsections (p)(1)(A)(ii)(II) or (p)(1)(B)(i)(II).
``(l) Trials With Non-Federal Support.--
``(1) In general.--The responsible person for a clinical
trial described in subsection (j)(3)(B) shall, not later than
the date specified in paragraph (3), submit to the Secretary--
``(A) the information described in subclauses (II)
through (X) of subsection (j)(3)(B)(iv), and with
respect to clinical trials in progress on the date of
enactment of the FACT Act, the information described in
subclause (I) of subsection (j)(3)(B)(iv); or
``(B) a statement containing information sufficient
to demonstrate to the Secretary that the information
described in subparagraph (A) cannot reasonably be
submitted, along with an estimated date of submission
of the information described in such subparagraph.
``(2) Sanction in case of noncompliance.--
``(A) Initial noncompliance.--If by the date
specified in paragraph (3), the Secretary has not
received the information or statement required to be
submitted to the Secretary under paragraph (1), the
Secretary shall--
``(i) transmit to the responsible person
for such trial a notice stating that such
responsible person shall be liable for the
civil monetary penalties described in
subparagraph (B) if the required information or
statement is not submitted to the Secretary
within 30 days of the date on which such notice is transmitted; and
``(ii) include and prominently display,
until such time as the Secretary receives the
information described in paragraph (1), as part
of the record of such trial in the database
described in subsection (j), a notice stating
that the results of such trials have not been
reported as required by law.
``(B) Civil monetary penalties for noncompliance.--
``(i) In general.--If by the date that is
30 days after the date on which a notice
described in subparagraph (A) is transmitted,
the Secretary has not received from the
responsible person involved the information or
statement required pursuant to such notice, the
Secretary shall, after providing the
opportunity for a hearing, order such
responsible person to pay a civil penalty of
$10,000 for each day after such date that the
information or statement is not submitted.
``(ii) Waivers.--In any case in which a
responsible person described in clause (i) is a
nonprofit entity, the Secretary may waive or
reduce the penalties applicable under such
clause to such person.
``(C) Submission of statement but not
information.--
``(i) In general.--If by the date specified
in paragraph (3), the Secretary has received a
statement described in paragraph (1)(B) but not
the information described in paragraph (1)(A)
the Secretary shall transmit to the responsible
person involved a notice stating that such
responsible person shall submit such
information by the date determined by the
Secretary in consultation with such responsible
person.
``(ii) Failure to comply.--If, by the date
specified by the Secretary in the notice under
clause (i), the Secretary has not received the
information described in paragraph (1)(A), the
Secretary shall--
``(I) transmit to the responsible
person involved a notice specifying the
information required to be submitted to
the Secretary and stating that such
responsible person shall be liable for
the civil monetary penalties described
in subparagraph (D) if such information
is not submitted to the Secretary
within 30 days of the date on which
such notice is transmitted; and
``(II) include and prominently
display, until such time as the
Secretary receives the information
described in paragraph (1)(A), as part
of the record of such trial in the
database described in subsection (j), a
notice stating that the results of such
trials have not been reported as
required by law.
``(D) Noncompliance.--
``(i) In general.--If by the date that is
30 days after the date on which a notice
described in subparagraph (C)(ii)(I) is
transmitted, the Secretary has not received
from the responsible person involved the
information required pursuant to such notice,
the Secretary, after providing the opportunity
for a hearing, order such responsible person to
pay a civil penalty of $10,000 for each day
after such date that the information is not
submitted.
``(ii) Waivers.--In any case in which a
responsible person described in clause (i) is a
nonprofit entity, the Secretary may waive or
reduce the penalties applicable under such
clause to such person.
``(E) Notice of publication of data.--If the
responsible person is the manufacturer or distributor
of the drug, biological product, or device involved,
the notice under subparagraphs (A)(i) and (C)(ii)(I)
shall include a notice that the Secretary shall publish
the data described in subsection (j)(3)(B) in the
database if the responsible person has not submitted
the information specified in the notice transmitted by
the date that is 6 months after the date of such
notice.
``(F) Publication of data.--Notwithstanding section
301(j) of the Federal Food, Drug, and Cosmetic Act,
section 1905 of title 18, United States Code, or any
other provision of law, if the responsible person is
the manufacturer or distributor of the drug,
biological product, or device involved, and if the responsible person
has not submitted to the Secretary the information specified in a
notice transmitted pursuant to subparagraph (A)(i) or (C)(ii)(I) by the
date that is 6 months after the date of such notice, the Secretary
shall publish in the registry information that--
``(i) is described in subsection (j)(3)(B);
and
``(ii) the responsible person has submitted
to the Secretary in any application, including
a supplemental application, for the 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.
``(3) Date specified.--The date specified in this paragraph
shall be the date that is 1 year from the earlier of--
``(A) the estimated completion date of the trial,
submitted under subsection (j)(3)(B)(vi)(I)(hh); or
``(B) the actual date of completion or termination
of the trial.
``(4) Use of funds.--
``(A) In general.--The Secretary shall deposit the
funds collected under paragraph (2) into an account and
use such funds, in 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 a disease or condition.
``(B) Funding decisions.--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 the FACT Act by the Director of the Agency
for Healthcare Research and Quality and periodically
updated as determined appropriate by the Director.
``(5) Inclusion in registry.--
``(A) General rule.--The Secretary shall, pursuant
to subsection (j)(5), include--
``(i) the data described in subsection
(j)(3)(A) and submitted under the amendments
made by section 4(a) of the FACT Act in the
registry described in subsection (j) as soon as
practicable after receiving such data; and
``(ii) the data described in clause (I) of
subsection (j)(3)(B)(iv) and submitted under
this subsection in the database described in
subsection (j) as soon as practicable after
receiving such data.
``(B) Other data.--
``(i) In general.--The Secretary shall,
pursuant to subsection (j)(5), include the data
described in subclauses (II) through (X) of
subsection (j)(3)(B)(iv) and submitted under
this section in the database described in
subsection (j)--
``(I) as soon as practicable after
receiving such data; or
``(II) in the case of data to which
clause (ii) applies, by the date
described in clause (iii).
``(ii) Data described.--This clause applies
to data described in clause (i) if--
``(I) the responsible person
involved requests a delay in the
inclusion in the database of such data
in order to have such data published in
a peer reviewed journal; and
``(II) the Secretary determines
that an attempt will be made to seek
such publication.
``(iii) Date for inclusion in registry.--
Subject to clause (iv), the date described in
this clause is the earlier of--
``(I) the date on which the data
involved is published as provided for
in clause (ii); or
``(II) the date that is 18 months
after the date on which such data is
submitted to the Secretary.
``(iv) Extension of date.--The Secretary
may extend the 18-month period described in
clause (iii)(II) for an additional 6 months if
the responsible person demonstrates to the
Secretary, prior to the expiration of such 18-
month period, that the data involved has been
accepted for publication by a journal described
in clause (ii)(I).
``(v) Modification of data.--Prior to
including data in the database under clause
(ii) or (iv), the Secretary shall permit the
responsible person to modify the data involved.
``(6) Effect.--The information with respect to a clinical
trial submitted to the Secretary under this subsection,
including data published by the Secretary pursuant to paragraph
(2)(F), may not be submitted by a person other than the
responsible person as part of, or referred to in, an
application for approval of a drug or device under section 505, 510,
515, or 520 of the Federal Food, Drug, and Cosmetic Act or of a
biological product under section 351, unless the information is
available from a source other than the registry or database described
in subsection (j).
``(m) Procedures and Waivers.--
``(1) Submission prior to notice.--Nothing in subsections
(k) through (l) shall be construed to prevent a principal
investigator or a responsible person from submitting any
information required under this subsection to the Secretary
prior to receiving any notice described in such subsections.
``(2) Ongoing trials.--A factually accurate statement that
a clinical trial is ongoing shall be deemed to be information
sufficient to demonstrate to the Secretary that the information
described in subsections (k)(1)(A) and (l)(1)(A) cannot
reasonably be submitted.
``(3) Information previously submitted.--Nothing in
subsections (k) through (l) shall be construed to require the
Secretary to send a notice to any principal investigator or
responsible person requiring the submission to the Secretary of
information that has already been submitted.
``(4) Submission format and technical standards.--
``(A) In general.--The Secretary shall, to the
extent practicable, accept submissions required under
this subsection in an electronic format and shall
establish interoperable technical standards for such
submissions.
``(B) Consistency of standards.--To the extent
practicable, the standards established under
subparagraph (A) shall be consistent with standards
adopted by the Consolidated Health Informatics
Initiative (or a successor organization to such
Initiative) to the extent such Initiative (or
successor) is in operation.
``(5) Trials completed prior to enactment.--The Secretary
shall establish procedures and mechanisms to allow for the
voluntary submission to the database of the information
described in subsection (j)(3)(B) with respect to clinical
trials completed prior to the date of enactment of the FACT
Act. In cases in which it is in the interest of public health,
the Secretary may require that information from such trials be
submitted to the database. Failure to comply with such a
requirement shall be deemed to be a failure to submit
information as required under this section, and the appropriate
remedies and sanctions under this section shall apply.
``(6) Trials not involving drugs, biological products, or
devices.--The Secretary shall establish procedures and
mechanisms to allow for the voluntary submission to the
database of the information described in subsection (j)(3)(B)
with respect to clinical trials that do not involve drugs,
biological products, or devices. In cases in which it is in the
interest of public health, the Secretary may require that
information from such trials be submitted to the database.
Failure to comply with such a requirement shall be deemed to be
a failure to submit information as required under this section,
and the appropriate remedies and sanctions under this section
shall apply.
``(7) Submission of inaccurate information.--
``(A) In general.--If the Secretary determines that
information submitted by a principal investigator or a
responsible person under this section is factually and
substantively inaccurate, the Secretary shall submit a
notice to the investigator or responsible person
concerning such inaccuracy that includes--
``(i) a summary of the inaccuracies
involved; and
``(ii) a request for corrected information
within 30 days.
``(B) Audit of information.--
``(i) In general.--The Secretary may
conduct audits of any information submitted
under subsection (j).
``(ii) Requirement.--Any principal
investigator or responsible person that has
submitted information under subsection (j)
shall permit the Secretary to conduct the audit
described in clause (i).
``(C) Changes to information.--Any change in the
information submitted by a principal investigator or a
responsible person under this section shall be reported
to the Secretary within 30 days of the date on which
such investigator or person became aware of the change
for purposes of updating the registry or the database.
``(D) Failure to correct.--If a principal
investigator or a responsible person fails to permit an
audit under subparagraph (B), provide corrected information pursuant to
a notice under subparagraph (A), or provide changed information under
subparagraph (C), the investigator or responsible person involved shall
be deemed to have failed to submit information as required under this
section and the appropriate remedies and sanction under this section
shall apply.
``(E) Corrections.--
``(i) In general.--The Secretary may
correct, through any means deemed appropriate
by the Secretary to protect public health, any
information included in the registry or the
database described in subsection (j) (including
information described or contained in a
publication referred to under subclause (VI) of
subsection (j)(3)(B)(iv)) that is--
``(I) submitted to the Secretary
for inclusion in the registry or the
database; and
``(II) factually and substantively
inaccurate or false or misleading.
``(ii) Reliance on information.--The
Secretary may rely on any information from a
clinical trial or a report of an adverse event
acquired or produced under the authority of
section 351 of this Act or of the Federal Food,
Drug, and Cosmetic Act in determining whether
to make corrections as provided for in clause
(i).
``(iii) Determinations relating to
misleading information.--For purposes of clause
(i)(II), in determining whether information is
misleading, the Secretary shall use the
standard described in section 201(n) of the
Federal Food, Drug, and Cosmetic Act that is
used to determine whether labeling or
advertising is misleading.
``(iv) Rule of construction.--This
subparagraph shall not be construed to
authorize the disclosure of information if--
``(I) such disclosure would
constitute an invasion of personal
privacy;
``(II) such information concerns a
method or process which as a trade
secret is entitled to protection within
the meaning of section 301(j) of the
Federal Food, Drug, and Cosmetic Act;
``(III) such disclosure would
disclose confidential commercial
information or a trade secret, other
than a trade secret described in
subclause (II), unless such disclosure
is necessary--
``(aa) to make a correction
as provided for under clause
(i); and
``(bb) protect the public
health; or
``(IV) if such disclosure relates
to a biological product for which no
license is in effect under section 351,
a drug for which no approved
application is in effect under section
505(c) of the Federal Food, Drug, and
Cosmetic Act, or a device that is not
cleared under section 510(k) of such
Act or for which no application is in
effect under section 515 of such Act.
``(v) Notice.--In the case of a disclosure
under clause (iv)(III), the Secretary shall
notify the manufacturer or distributor of the
drug, biological product, or device involved--
``(I) at least 30 days prior to
such disclosure; or
``(II) if immediate disclosure is
necessary to protect the public health,
concurrently with such disclosure.
``(8) Waivers regarding clinical trial results.--The
Secretary may waive the requirements of subsections (k)(1) and
(l)(1) that the results of clinical trials be submitted to the
Secretary, upon a written request from the responsible person
if the Secretary determines that extraordinary circumstances
justify the waiver and that providing the waiver is in the
public interest or consistent with the protection of public
health.
``(n) Trials Conducted Outside of the United States.--
``(1) In general.--With respect to clinical trials
described in paragraph (2), the responsible person shall submit
to the Secretary the information required under subclauses (II)
through (X) of subsection (j)(3)(B)(iv). Failure to comply with
this paragraph shall be deemed to be a failure to submit
information as required under this section, and the appropriate
remedies and sanctions under this section shall apply.
``(2) Clinical trial described.--A clinical trial is
described in this paragraph if--
``(A) such trial is conducted outside of the United
States; and
``(B) the data from such trial is--
``(i) 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; or
``(ii) used in advertising or labeling to
make a claim about the drug, device, or
biological product involved.
``(o) Definitions; Individual Liability.--
``(1) Responsible person.--
``(A) In general.--In this section, the term
`responsible person' with respect to a clinical trial,
means--
``(i) if such clinical trial is the subject
of an investigational new drug application or
an application for an investigational device
exemption, the sponsor of such investigational
new drug application or such application for an
investigational device exemption; or
``(ii) except as provided in subparagraph
(B), if such clinical trial is not the subject
of an investigational new drug application or
an application for an investigational device
exemption--
``(I) the person that provides the
largest share of the monetary support
(such term does not include in-kind
support) for the conduct of such trial;
or
``(II) in the case in which the
person described in subclause (I) is a
Federal or State agency, the principal
investigator of such trial.
``(B) Nonprofit entities and requesting persons.--
``(i) Nonprofit entities.--For purposes of
subparagraph (A)(ii)(I), if the person that
provides the largest share of the monetary
support for the conduct of the clinical trial
involved is a nonprofit entity, the responsible
person for purposes of this section shall be--
``(I) the nonprofit entity; or
``(II) if the nonprofit entity and
the principal investigator of such
trial jointly certify to the Secretary
that the principal investigator will be
responsible for submitting the
information described in subsection
(j)(3)(B) for such trial, the principal
investigator.
``(ii) Requesting persons.--For purposes of
subparagraph (A)(ii)(I), if a person--
``(I) has submitted a request to
the Secretary that the Secretary
recognize the person as the responsible
person for purposes of this section;
and
``(II) the Secretary determines
that such person--
``(aa) provides monetary
support for the conduct of such
trial;
``(bb) is responsible for
the conduct of such trial; and
``(cc) will be responsible
for submitting the information
described in subsection
(j)(3)(B) for such trial;
such person shall be the responsible person for
purposes of this section.
``(2) Drug, device, biological product.--In this section--
``(A) the terms `drug' and `device' have the
meanings given such terms in section 201 of the Federal
Food, Drug, and Cosmetic Act; and
``(B) the term `biological product' has the meaning
given such term in section 351 of this Act.
``(3) Individual liability.--
``(A) Limitation on liability of individuals.--No
individual shall be liable for any civil monetary
penalty under this section.
``(B) Individuals who are responsible persons.--If
a responsible person under subparagraph (A) or (B) of
paragraph (1) is an individual, such individual shall be subject to the
procedures and conditions described in subsection (k).''.
(c) Authorization of Appropriations.--Section 402 of the Public
Health Service Act (42 U.S.C. 282), as amended by this section, is
further amended by adding at the end the following:
``(s) Authorization of Appropriations.--There are authorized to be
appropriated, such sums as may be necessary to carry out this
section.''.
SEC. 4. REVIEW AND APPROVAL OF PROPOSALS FOR RESEARCH.
(a) Amendments.--Section 492A(a) of the Public Health Service Act
(42 U.S.C. 289a-1(a)) is amended--
(1) in paragraph (1)(A), by striking ``unless'' and all
that follows through the period and inserting the following:
``unless--
``(i) the application has undergone review
in accordance with such section and has been
recommended for approval by a majority of the
members of the Board conducting the review;
``(ii) such Board has submitted to the
Secretary a notification of such approval; and
``(iii) with respect to an application
involving a clinical trial to which section
402(j) applies, the principal investigator who
has submitted such application has submitted to
the Secretary for inclusion in the registry and
the database described in section 402(j) the
information described in paragraph (3)(A) and
subclause (I) of paragraph (3)(B)(iv) of such
section.''; and
(2) by adding at the end the following:
``(3) Cost recovery.--Nonprofit entities may recover the
full costs associated with compliance with the requirements of
paragraph (1) from the Secretary as a direct cost of
research.''.
(b) Regulations.--The Secretary of Health and Human Services shall
modify the regulations promulgated at part 46 of title 45, Code of
Federal Regulations, part 50 of title 21, Code of Federal Regulations,
and part 56 of title 21, Code of Federal Regulations, to reflect the
amendments made by subsection (a).
SEC. 5. 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 entering into of a contract or other agreement by a
responsible person or a manufacturer of a drug, biological product, or
device with an individual who is not an employee of such responsible
person or manufacturer, or the performance of any other act by such a
responsible person or manufacturer, that prohibits, limits, or imposes
unreasonable delays on the ability of such individual to--
``(A) discuss the results of a clinical trial at a
scientific meeting or any other public or private forum; or
``(B) publish the results of a clinical trial or a
description or discussion of the results of a clinical trial in
a scientific journal or any other publication.
``(2) The entering into a contract or other agreement by a
responsible person or a manufacturer of a drug, biological product, or
device with an academic institution or a health care facility, or the
performance of any other act by such a responsible person or
manufacturer, that prohibits, limits, or imposes unreasonable delays on
the ability of an individual who is not an employee of such responsible
person or manufacturer to--
``(A) discuss the results of a clinical trial at a
scientific meeting or any other public or private forum; or
``(B) publish the results of a clinical trial or a
description or discussion of the results of a clinical trial in
a scientific journal or any other publication.''.
SEC. 6. REPORTS.
(a) Implementation Report.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human Services shall
submit to the appropriate committees of Congress a report on the status
of the implementation of the requirements of the amendments made by
section 3 that includes a description of the number and types of
clinical trials for which information has been submitted under such
amendments.
(b) Data Collection.--
(1) In general.--The Secretary of Health and Human Services
shall enter into a contract with the Institute of Medicine for
the conduct of a study concerning the extent to which data
submitted to the registry under section 402(j) of the Public
Health Service Act (42 U.S.C. 282(j)) has impacted the public
health.
(2) Report.--Not later than 6 months after the date on
which a contract is entered into under paragraph (1), the
Institute of Medicine shall submit to the Secretary of Health
and Human Services a report on the results of the study
conducted under such paragraph. Such report shall include
recommendations for changes to the registry, the database, and
the data submission requirements that would benefit the public
health.
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