[Congressional Record Volume 153, Number 110 (Wednesday, July 11, 2007)]
[House]
[Pages H7568-H7606]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007
Mr. DINGELL. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 2900) to amend the Federal Food, Drug, and Cosmetic Act to
revise and extend the user-fee programs for prescription drugs and for
medical devices, to enhance the postmarket authorities of the Food and
Drug Administration with respect to the safety of drugs, and for other
purposes, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 2900
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 ``Food and Drug Administration
Amendments Act of 2007''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
Sec. 101. Short title; references in title.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Fees relating to advisory review of prescription-drug
television advertising.
Sec. 105. Reauthorization; reporting requirements.
Sec. 106. Sunset dates.
TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
Sec. 201. Short title; references in title.
Subtitle A--Fees Related to Medical Devices
Sec. 211. Definitions.
Sec. 212. Authority to assess and use device fees.
Sec. 213. Annual reports.
Sec. 214. Consultation.
Sec. 215. Additional authorization of appropriations for postmarket
safety information.
Sec. 216. Effective date.
Sec. 217. Sunset clause.
Subtitle B--Amendments Regarding Regulation of Medical Devices
Sec. 221. Extension of authority for third party review of premarket
notification.
Sec. 222. Registration.
Sec. 223. Filing of lists of drugs and devices manufactured, prepared,
propagated, and compounded by registrants; statements;
accompanying disclosures.
Sec. 224. Electronic registration and listing.
Sec. 225. Report by Government Accountability Office.
Sec. 226. Unique device identification system.
Sec. 227. Frequency of reporting for certain devices.
Sec. 228. Inspections by accredited persons.
Sec. 229. Study of nosocomial infections relating to medical devices.
TITLE III--PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007
Sec. 301. Short title.
Sec. 302. Tracking pediatric device approvals.
Sec. 303. Modification to humanitarian device exemption.
Sec. 304. Encouraging pediatric medical device research.
Sec. 305. Demonstration grants for improving pediatric device
availability.
Sec. 306. Amendments to office of pediatric therapeutics and pediatric
advisory committee.
Sec. 307. Postmarket Studies.
TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007
Sec. 401. Short title.
Sec. 402. Reauthorization of Pediatric Research Equity Act.
Sec. 403. Government Accountability Office report.
TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007
Sec. 501. Short title.
Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act.
TITLE VI--REAGAN-UDALL FOUNDATION
Sec. 601. The Reagan-Udall Foundation for the Food and Drug
Administration.
Sec. 602. Office of the Chief Scientist.
Sec. 603. Critical path public-private partnerships.
TITLE VII--CONFLICTS OF INTEREST
Sec. 701. Conflicts of interest.
TITLE VIII--CLINICAL TRIAL DATABASES
Sec. 801. Clinical trial registry database and clinical trial results
database.
Sec. 802. Study by Government Accountability Office.
[[Page H7569]]
TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS
Sec. 901. Postmarket studies and clinical trials regarding human drugs;
risk evaluation and mitigation strategies.
Sec. 902. Enforcement.
Sec. 903. No effect on withdrawal or suspension of approval.
Sec. 904. Benefit-risk assessments.
Sec. 905. Postmarket risk identification and analysis system for active
surveillance and assessment.
Sec. 907. Statement for inclusion in direct-to-consumer advertisements
of drugs.
Sec. 908. Clinical trial guidance for antibiotic drugs.
Sec. 909. Prohibition against food to which drugs or biological
products have been added.
Sec. 910. Assuring pharmaceutical safety.
Sec. 911. Orphan antibiotic drugs.
Sec. 912. Citizen petitions and petitions for stay of agency action.
Sec. 913. Authorization of appropriations.
Sec. 914. Effective date and applicability.
TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
SEC. 101. SHORT TITLE; REFERENCES IN TITLE.
(a) Short Title.--This title may be cited as the
``Prescription Drug User Fee Amendments of 2007''.
(b) References in Act.--Except as otherwise specified,
amendments made by this title to a section or other provision
of law are amendments to such section or other provision of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.).
SEC. 102. DEFINITIONS.
Section 735 (21 U.S.C. 379g) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), by striking ``505(b)(1),'' and
inserting ``505(b), or'';
(B) by striking subparagraph (B); and
(C) by redesignating subparagraph (C) as subparagraph (B);
(2) in paragraph (3)(C)--
(A) by striking ``505(j)(7)(A)'' and inserting
``505(j)(7)(A) (not including the discontinued section of
such list),''; and
(B) by inserting before the period ``(not including the
discontinued section of such list)'';
(3) in paragraph (4), by inserting before the period at the
end the following: ``(such as capsules, tablets, or
lyophilized products before reconstitution)'';
(4) by amending paragraph (6)(F) to read as follows:
``(F) Postmarket safety activities with respect to drugs
approved under human drug applications or supplements,
including the following activities:
``(i) Collecting, developing, and reviewing safety
information on approved drugs, including adverse event
reports.
``(ii) Developing and using improved adverse-event data-
collection systems, including information technology systems.
``(iii) Developing and using improved analytical tools to
assess potential safety problems, including access to
external data bases.
``(iv) Implementing and enforcing section 505(o) (relating
to postapproval studies and clinical trials and labeling
changes) and section 505(p) (relating to risk evaluation and
mitigation strategies).
``(v) Preparing and making publicly available (including on
the website of the Food and Drug Administration) a summary
analysis of the adverse drug reaction reports received for
recently approved drugs, including identification of any new
risks not previously identified, potential new risks, or
known risks reported in unusual number not previously
identified within 18 months of the drug's initial marketing
or after exposure of 10,000 individuals to the drug,
whichever is later.
``(vi) Conducting regular, bi-weekly screening of the
Adverse Event Reporting System database and developing a
report every 15 days on any new safety concerns.
``(vii) Ensuring that the reports available to the public
under the Adverse Event Reporting System are updated at least
every 6 months.
``(viii) Reporting to the Congress on--
``(I) the recommendations received in consultations with,
and reports from, the Office of Surveillance and Epidemiology
within the Food and Drug Administration on postmarket safety
activities;
``(II) a description of the actions taken on those
recommendations; and
``(III) if no action is taken, or a different action is
taken relative to the action recommended by the Office of
Surveillance and Epidemiology, an explanation of why no
action or a different action was taken.
``(ix) On an annual basis, reviewing the entire backlog of
postmarket safety commitments to determine which commitments
require revision or should be eliminated, reporting to the
Congress on these determinations, and assigning start dates
and estimated completion dates for such commitments.
``(x) Developing postmarket safety performance measures,
including those listed in clauses (v) through (ix), that are
as measurable and rigorous as the ones already developed for
premarket review.'';
(5) in paragraph (8)--
(A) by striking ``April of the preceding fiscal year'' and
inserting ``October of the preceding fiscal year''; and
(B) by striking ``April 1997'' and inserting ``October
1996'';
(6) by redesignating paragraph (9) as paragraph (11); and
(7) by inserting after paragraph (8) the following
paragraphs:
``(9) The term `person' includes an affiliate thereof.
``(10) The term `active', with respect to a commercial
investigational new drug application, means such an
application to which information was submitted during the
relevant period.''.
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is
amended--
(1) in the matter preceding paragraph (1), by striking
``2003'' and inserting ``2008'';
(2) in paragraph (1)--
(A) in subparagraph (D)--
(i) in the heading, by inserting ``or withdrawn before
filing'' after ``refused for filing''; and
(ii) by inserting before the period at the end the
following: ``or withdrawn without a waiver before filing'';
(B) by redesignating subparagraphs (E) and (F) as
subparagraphs (F) and (G), respectively; and
(C) by inserting after subparagraph (D) the following:
``(E) Fees for applications previously refused for filing
or withdrawn before filing.--A human drug application or
supplement that was submitted but was refused for filing, or
was withdrawn before being accepted or refused for filing,
shall be subject to the full fee under subparagraph (A) upon
being resubmitted or filed over protest, unless the fee is
waived or reduced under subsection (d).''; and
(3) in paragraph (2)--
(A) in subparagraph (A), by striking ``subparagraph (B)''
and inserting ``subparagraphs (B) and (C)''; and
(B) by adding at the end the following:
``(C) Special rules for positron emission tomography
drugs.--
``(i) In general.--Except as provided in clause (ii), each
person who is named as the applicant in an approved human
drug application for a positron emission tomography drug
shall be subject under subparagraph (A) to one-sixth of an
annual establishment fee with respect to each such
establishment identified in the application as producing
positron emission tomography drugs under the approved
application.
``(ii) Exception from annual establishment fee.--Each
person who is named as the applicant in an application
described in clause (i) shall not be assessed an annual
establishment fee for a fiscal year if the person certifies
to the Secretary, at a time specified by the Secretary and
using procedures specified by the Secretary, that--
``(I) the person is a not-for-profit medical center that
has only 1 establishment for the production of positron
emission tomography drugs; and
``(II) at least 95 percent of the total number of doses of
each positron emission tomography drug produced by such
establishment during such fiscal year will be used within the
medical center.
``(iii) Definition.--For purposes of this subparagraph, the
term `positron emission tomography drug' has the meaning
given to the term `compounded positron emission tomography
drug' in section 201(ii), except that subparagraph (1)(B) of
such section shall not apply.''.
(b) Fee Revenue Amounts.--Section 736(b) (21 U.S.C.
379h(b)) is amended to read as follows:
``(b) Fee Revenue Amounts.--
``(1) In general.--For each of the fiscal years 2008
through 2012, fees under subsection (a) shall, except as
provided in subsections (c), (d), (f), and (g), be
established to generate a total revenue amount under such
subsection that is equal to the sum of--
``(A) $392,783,000; and
``(B) an amount equal to the modified workload adjustment
factor for fiscal year 2007 (as determined under paragraph
(3)).
``(2) Types of fees.--Of the total revenue amount
determined for a fiscal year under paragraph (1)--
``(A) one-third shall be derived from fees under subsection
(a)(1) (relating to human drug applications and supplements);
``(B) one-third shall be derived from fees under subsection
(a)(2) (relating to prescription drug establishments); and
``(C) one-third shall be derived from fees under subsection
(a)(3) (relating to prescription drug products).
``(3) Modified workload adjustment factor for fiscal year
2007.--For purposes of paragraph (1)(B), the Secretary shall
determine the modified workload adjustment factor by
determining the dollar amount that results from applying the
methodology that was in effect under subsection (c)(2) for
fiscal year 2007 to the amount $354,893,000, except that,
with respect to the portion of such determination that is
based on the change in the total number of commercial
investigational new drug applications, the Secretary shall
count the number of such applications that were active during
the most recent 12-month period for which data on such
submissions is available.
``(4) Additional fee revenues for drug safety.--
``(A) In general.--For each of the fiscal years 2008
through 2012, paragraph (1)(A) shall, subject to subparagraph
(C), be applied
[[Page H7570]]
by substituting the amount determined under subparagraph (B)
for `$392,783,000'.
``(B) Amount determined.--For each of the fiscal years 2008
through 2012, the amount determined under this subparagraph
is the sum of--
``(i) $392,783,000; plus
``(ii) an amount equal to--
``(I)(aa) for fiscal year 2008, $25,000,000;
``(bb) for fiscal year 2009, $35,000,000;
``(cc) for fiscal year 2010, $45,000,000;
``(dd) for fiscal year 2011, $55,000,000; and
``(ee) for fiscal year 2012, $65,000,000; minus
``(II) the amount equal to the excess amount in item (bb),
provided that--
``(aa) the amount of the total appropriation for the Food
and Drug Administration for such fiscal year (excluding the
amount of fees appropriated for such fiscal year) exceeds the
amount of the total appropriation for the Food and Drug
Administration for fiscal year 2007 (excluding the amount of
fees appropriated for such fiscal year), adjusted as provided
under subsection (c)(1); and
``(bb) the amount of the total appropriations for the
process of human drug review at the Food and Drug
Administration for such fiscal year (excluding the amount of
fees appropriated for such fiscal year) exceeds the amount of
appropriations for the process of human drug review at the
Food and Drug Administration for fiscal year 2007 (excluding
the amount of fees appropriated for such fiscal year),
adjusted as provided under subsection (c)(1).
In making the adjustment under subclause (II) for any of
fiscal years 2008 through 2012, subsection (c)(1) shall be
applied by substituting `2007' for `2008'.
``(C) Limitation.--This paragraph shall not apply for any
fiscal year if the amount described under subparagraph
(B)(ii) is less than 0.''.
(c) Adjustments to Fees.--
(1) Inflation adjustment.--Section 736(c)(1) (21 U.S.C.
379h(c)(1)) is amended--
(A) in the matter preceding subparagraph (A), by striking
``The revenues established in subsection (b)'' and inserting
``For fiscal year 2009 and subsequent fiscal years, the
revenues established in subsection (b)'';
(B) in subparagraph (A), by striking ``or'' at the end;
(C) in subparagraph (B), by striking the period at the end
and inserting ``, or'';
(D) by inserting after subparagraph (B) the following:
``(C) the average annual change in the cost, per full-time
equivalent position of the Food and Drug Administration, of
all personnel compensation and benefits paid with respect to
such positions for the first 5 years of the preceding 6
fiscal years.''; and
(E) in the matter following subparagraph (C) (as added
under this paragraph), by striking ``fiscal year 2003'' and
inserting ``fiscal year 2008''.
(2) Workload adjustment.--Section 736(c)(2) (21 U.S.C.
379h(c)(2)) is amended--
(A) in the matter preceding subparagraph (A), by striking
``Beginning with fiscal year 2004,'' and inserting ``For
fiscal year 2009 and subsequent fiscal years,'';
(B) in subparagraph (A), in the first sentence--
(i) by striking ``human drug applications,'' and inserting
``human drug applications (adjusted for changes in review
activities, as described in the notice that the Secretary is
required to publish in the Federal Register under this
subparagraph),'';
(ii) by striking ``commercial investigational new drug
applications,''; and
(iii) by inserting before the period the following: ``, and
the change in the total number of active commercial
investigational new drug applications (adjusted for changes
in review activities, as so described) during the most recent
12-month period for which data on such submissions is
available'';
(C) in subparagraph (B), by adding at the end the
following: ``Any adjustment for changes in review activities
made in setting fees and revenue amounts for fiscal year 2009
may not result in the total workload adjustment being more
than 2 percentage points higher than it would have been in
the absence of the adjustment for changes in review
activities.''; and
(D) by adding at the end the following:
``(C) The Secretary shall contract with an independent
accounting firm to study the adjustment for changes in review
activities applied in setting fees and revenue amounts for
fiscal year 2009 and to make recommendations, if warranted,
for future changes in the methodology for calculating the
adjustment. After review of the recommendations, the
Secretary shall, if warranted, make appropriate changes to
the methodology, and the changes shall be effective for each
of the fiscal years 2010 through 2012. The Secretary shall
not make any adjustment for changes in review activities for
any fiscal year after 2009 unless such study has been
completed.''.
(3) Rent and rent-related cost adjustment.--Section 736(c)
(21 U.S.C. 379h(c)) is amended--
(A) by redesignating paragraphs (3), (4), and (5) as
paragraphs (4), (5), and (6), respectively; and
(B) by inserting after paragraph (2) the following:
``(3) Rent and rent-related cost adjustment.--For fiscal
year 2010 and each subsequent fiscal year, the Secretary
shall, before making adjustments under paragraphs (1) and
(2), decrease the fee revenue amount established in
subsection (b) if actual costs paid for rent and rent-related
expenses for the preceding fiscal year are less than
estimates made for such year in fiscal year 2006. Any
reduction made under this paragraph shall not exceed the
amount by which such costs fall below the estimates made in
fiscal year 2006 for such fiscal year, and shall not exceed
$11,721,000 for any fiscal year.''.
(4) Final year adjustment.--Section 736(c) (21 U.S.C.
379h(c)) is amended--
(A) in paragraph (4) (as redesignated by paragraph
(3)(A))--
(i) by striking ``2007'' each place it appears and
inserting ``2012'';
(ii) by striking ``paragraphs (1) and (2)'' and inserting
``paragraphs (1), (2), and (3)''; and
(iii) by striking ``2008'' and inserting ``2013''; and
(B) in paragraph (5) (as so redesignated), by striking
``2002'' and inserting ``2007''.
(d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C.
379h(d)) is amended--
(1) in paragraph (1), in the matter preceding subparagraph
(A)--
(A) by inserting after ``The Secretary shall grant'' the
following: ``to a person who is named as the applicant in a
human drug application''; and
(B) by inserting ``to that person'' after ``one or more
fees assessed'';
(2) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively;
(3) by inserting after paragraph (1) the following:
``(2) Considerations.--In determining whether to grant a
waiver or reduction of a fee under paragraph (1), the
Secretary shall consider only the circumstances and assets of
the applicant involved and any affiliate of the applicant.'';
and
(4) in paragraph (4) (as redesignated by paragraph (2)), in
subparagraph (A), by inserting before the period the
following: ``, and that does not have a drug product that has
been approved under a human drug application and introduced
or delivered for introduction into interstate commerce''.
(e) Crediting and Availability of Fees.--
(1) Authorization of appropriations.--Section 736(g)(3) (21
U.S.C. 379h(g)(3)) is amended to read as follows:
``(3) Authorization of appropriations.--For each of the
fiscal years 2008 through 2012, there is authorized to be
appropriated for fees under this section an amount equal to
the total revenue amount determined under subsection (b) for
the fiscal year, as adjusted or otherwise affected under
subsection (c) and paragraph (4) of this subsection.''.
(2) Offset.--Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is
amended to read as follows:
``(4) Offset.--If the sum of the cumulative amount of fees
collected under this section for the fiscal years 2008
through 2010 and the amount of fees estimated to be collected
under this section for fiscal year 2011 exceeds the
cumulative amount appropriated under paragraph (3) for the
fiscal years 2008 through 2011, the excess shall be credited
to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
authorized to be collected under this section pursuant to
appropriation Acts for fiscal year 2012.''.
(f) Exemption for Orphan Drugs.--Section 736 (21 U.S.C.
379h) is further amended by adding at the end the following:
``(k) Orphan Drugs.--A drug designated under section 526
for a rare disease or condition and approved under section
505 or under section 351 of the Public Health Service Act
shall be exempt from product and facility fees under this
section, provided that the drug meets all of the following:
``(1) The drug had United States sales in the previous year
of less than $25,000,000 for the active moiety, for all
indications, dosage forms, and strengths for which the drug
is approved and for any off-label uses.
``(2) The drug meets the public health requirements
contained in this Act as such requirements are applied to
requests for waivers for product and facility fees.
``(3) The drug is owned or licensed and marketed by a
company that had less than $100,000,000 in gross worldwide
revenue during the previous year.''.
(g) Conforming Amendment.--Section 736(a) (21 U.S.C.
379h(a)) is amended in paragraphs (1)(A)(i), (1)(A)(ii),
(2)(A), and (3)(A) by striking ``(c)(4)'' each place such
term appears and inserting ``(c)(5)''.
SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-
DRUG TELEVISION ADVERTISING.
Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et
seq.) is amended by adding after section 736 the following:
``SEC. 736A. FEES RELATING TO ADVISORY REVIEW OF
PRESCRIPTION-DRUG TELEVISION ADVERTISING.
``(a) Types of Direct-to-Consumer Television Advertisement
Review Fees.--Beginning in fiscal year 2008, the Secretary
shall assess and collect fees in accordance with this section
as follows:
``(1) Advisory review fee.--
``(A) In general.--With respect to a proposed direct-to-
consumer television advertisement (referred to in this
section as a `DTC advertisement'), each person that on or
after October 1, 2007, submits such an advertisement for
advisory review by the Secretary prior to its initial public
broadcast (referred to in this section as `prebroadcast
advisory review') shall, except as provided in subparagraph
(B), be subject to a fee established under subsection (c)(3).
``(B) Exception for required submissions.--A DTC
advertisement that is required under section 502(n) to be
submitted
[[Page H7571]]
to the Secretary prior to initial public broadcast is not
subject to a fee under subparagraph (A) unless the sponsor
designates the submission as a submission for prebroadcast
advisory review.
``(C) Notice to secretary of number of advertisements.--Not
later than June 1 of each fiscal year, the Secretary shall
publish a notice in the Federal Register requesting any
person to notify the Secretary within 30 days of the number
of DTC advertisements the person intends to submit for
prebroadcast advisory review in the next fiscal year.
``(D) Payment.--
``(i) In general.--The fee required by subparagraph (A)
(referred to in this section as `an advisory review fee')
shall be due not later than October 1 of the fiscal year in
which the DTC advertisement involved is intended be submitted
for prebroadcast advisory review, subject to subparagraph
(F)(i).
``(ii) Effect of submission.--Notification of the Secretary
under subparagraph (C) of the number of DTC advertisements a
person intends to submit for prebroadcast advisory review is
a legally binding commitment by that person to pay the annual
advisory review fee for that number of submissions on or
before October 1 of the fiscal year in which the
advertisement is intended to be submitted.
``(iii) Notice regarding carryover submissions.--In making
a notification under subparagraph (C), the person involved
shall in addition notify the Secretary if under subparagraph
(F)(i) the person intends to submit a DTC advertisement for
which the advisory review fee has already been paid. If the
person does not so notify the Secretary, each DTC
advertisement submitted by the person for prebroadcast
advisory review in the fiscal year involved shall be subject
to the advisory review fee.
``(E) Modification of advisory review fee.--
``(i) Late payment.--If a person has submitted a
notification under subparagraph (C) with respect to a fiscal
year and has not paid all advisory review fees due under
subparagraph (D) on or before November 1 of such fiscal year,
the fees are regarded as late and a revised due date and an
increase in the amount of fees applies in accordance with
this clause, notwithstanding any other provision of this
section. For such person, the advisory review fee for each
DTC advertisement submitted in such fiscal year for
prebroadcast advisory review shall be due and payable 20 days
before the advertisement is submitted to the Secretary, and
each such fee shall be revised to be equal to 150 percent of
the fee that otherwise would have applied pursuant to
subsection (c)(3).
``(ii) Exceeding identified number of submissions.--If a
person submits a number of DTC ads for prebroadcast advisory
review in a fiscal year that exceeds the number identified by
the person under subparagraph (C), a revised due date and an
increase in the amount of fees applies under this clause for
each submission in excess of such number, notwithstanding any
other provision of this section. For each such DTC ad, the
advisory review fee shall be due and payable 20 days before
the advertisement is submitted to the Secretary, and the fee
shall be revised to be equal to 150 percent of the fee that
otherwise would have applied pursuant to subsection (c)(3).
``(F) Limits.--
``(i) Submissions.--For each advisory review fee paid by a
person for a fiscal year, the person is entitled to
acceptance for advisory review by the Secretary of one DTC
advertisement and acceptance of one resubmission for advisory
review of the same advertisement. The advertisement shall be
submitted for review in the fiscal year for which the fee was
assessed, except that a person may carry over not more than
one paid advisory review submission to the next fiscal year.
Resubmissions may be submitted without regard to the fiscal
year of the initial advisory review submission.
``(ii) No refunds.--Except as provided by subsection (f),
fees paid under subparagraph (A) shall not be refunded.
``(iii) No waivers, exemptions, or reductions.--The
Secretary shall not grant a waiver, exemption, or reduction
of any fees due or payable under this section.
``(iv) Right to advisory review not transferable.--The
right to an advisory review under this paragraph is not
transferable, except to a successor in interest.
``(2) Operating reserve fee.--
``(A) In general.--Each person that on or after October 1,
2007, is assessed an advisory review fee under paragraph (1)
shall be subject to fee established under subsection (d)(2)
referred to in this section as an `operating reserve fee' for
the first fiscal year in which an advisory review fee is
assessed to such person. The person is not subject to an
operating reserve fee for any other fiscal year.
``(B) Payment.--Except as provided in subparagraph (C), the
operating reserve fee shall be due no later than October 1 of
the first fiscal year in which the person is required to pay
an advisory review fee under paragraph (1).
``(C) Late notice of submission.--If, in the first fiscal
year of a person's participation in the program under this
section, that person submits any DTC advertisements for
prebroadcast advisory review that are in excess of the number
identified by that person in response to the Federal Register
notice described in subsection (a)(1)(C), that person shall
pay an operating reserve fee for each of those advisory
reviews equal to the advisory review fee for each submission
established under paragraph (1)(D)(ii). Fees required by this
subparagraph shall be in addition to any fees required by
subparagraph (A). Fees under this subparagraph shall be due
20 days before any DTC advertisement is submitted by such
person to the Secretary for prebroadcast advisory review.
``(b) Advisory Review Fee Revenue Amounts.--Fees under
subsection (a)(1) shall be established to generate revenue
amounts of $6,250,000 for each of fiscal years 2008 through
2012, as adjusted pursuant to subsections (c) and (g)(4).
``(c) Adjustments.--
``(1) Inflation adjustment.--Beginning with fiscal year
2009, the revenues established in subsection (b) shall be
adjusted by the Secretary by notice, published in the Federal
Register, for a fiscal year to reflect the greater of--
``(A) the total percentage change that occurred in the
Consumer Price Index for all urban consumers (all items; U.S.
city average), for the 12-month period ending June 30
preceding the fiscal year for which fees are being
established;
``(B) the total percentage change for the previous fiscal
year in basic pay under the General Schedule in accordance
with section 5332 of title 5, United States Code, as adjusted
by any locality-based comparability payment pursuant to
section 5304 of such title for Federal employees stationed in
the District of Columbia; or
``(C) the average annual change in the cost, per full-time
equivalent position of the Food and Drug Administration, of
all personnel compensation and benefits paid with respect to
such positions for the first 5 fiscal years of the previous 6
fiscal years.
The adjustment made each fiscal year by this subsection will
be added on a compounded basis to the sum of all adjustments
made each fiscal year after fiscal year 2008 under this
subsection.
``(2) Workload adjustment.--Beginning with fiscal year
2009, after the fee revenues established in subsection (b)
are adjusted for a fiscal year for inflation in accordance
with paragraph (1), the fee revenues shall be adjusted
further for such fiscal year to reflect changes in the
workload of the Secretary with respect to the submission of
DTC advertisements for advisory review prior to initial
broadcast. With respect to such adjustment:
``(A) The adjustment shall be determined by the Secretary
based upon the number of DTC advertisements identified
pursuant to subsection (a)(1)(C) for the upcoming fiscal
year, excluding allowable previously paid carry over
submissions. The adjustment shall be determined by
multiplying the number of such advertisements projected for
that fiscal year that exceeds 150 by $27,600 (adjusted each
year beginning with fiscal year 2009 for inflation in
accordance with paragraph (1)). The Secretary shall publish
in the Federal Register the fee revenues and fees resulting
from the adjustment and the supporting methodologies.
``(B) Under no circumstances shall the adjustment result in
fee revenues for a fiscal year that are less than the fee
revenues established for the prior fiscal year.
``(3) Annual fee setting for advisory review.--
``(A) In general.--Not later than August 1 of each fiscal
year, the Secretary shall establish for the next fiscal year
the DTC advertisement advisory review fee under subsection
(a)(1), based on the revenue amounts established under
subsection (b), the adjustments provided under paragraphs (1)
and (2), and the number of DTC advertisements identified
pursuant to subsection (a)(1)(C), excluding allowable
previously-paid carry over submissions. The annual advisory
review fee shall be established by dividing the fee revenue
for a fiscal year (as adjusted pursuant to this subsection)
by the number of DTC advertisements so identified, excluding
allowable previously-paid carry over submissions.
``(B) Fiscal year 2008 fee limit.--Notwithstanding
subsection (b) and the adjustments pursuant to this
subsection, the fee established under subparagraph (A) for
fiscal year 2008 may not be more than $83,000 per submission
for advisory review.
``(C) Annual fee limit.--Notwithstanding subsection (b) and
the adjustments pursuant to this subsection, the fee
established under subparagraph (A) for a fiscal year after
fiscal year 2008 may not be more than 50 percent more than
the fee established for the prior fiscal year.
``(D) Limit.--The total amount of fees obligated for a
fiscal year may not exceed the total costs for such fiscal
year for the resources allocated for the process for the
advisory review of prescription drug advertising.
``(d) Operating Reserves.--
``(1) In general.--The Secretary shall establish in the
Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation a
Direct-to-Consumer Advisory Review Operating Reserve, of at
least $6,250,000 in fiscal year 2008, to continue the program
under this section in the event the fees collected in any
subsequent fiscal year pursuant to subsection (a)(1) do not
generate the fee revenue amount established for that fiscal
year.
``(2) Fee setting.--The Secretary shall establish the
operating reserve fee under subsection (a)(2)(A) for each
person required to pay the fee by multiplying the number of
DTC advertisements identified by that person pursuant to
subsection (a)(1)(C) by the advisory review fee established
pursuant to subsection (c)(3) for that fiscal year, except
[[Page H7572]]
that in no case shall the operating reserve fee assessed be
less than the operating reserve fee assessed if the person
had first participated in the program under this section in
fiscal year 2008.
``(3) Use of operating reserve.--The Secretary may use
funds from the reserves only to the extent necessary in any
fiscal year to make up the difference between the fee revenue
amount established for that fiscal year under subsections (b)
and (c) and the amount of fees actually collected for that
fiscal year pursuant to subsection (a)(1), or to pay costs of
ending the program under this section if it is terminated
pursuant to subsection (f) or not reauthorized beyond fiscal
year 2012.
``(4) Refund of operating reserves.--Within 120 days of the
end of fiscal year 2012, or if the program under this section
ends early pursuant to subsection (f), the Secretary, after
setting aside sufficient operating reserve amounts to
terminate the program under this section, shall refund all
amounts remaining in the operating reserve on a pro rata
basis to each person that paid an operating reserve fee
assessment. In no event shall the refund to any person exceed
the total amount of operating reserve fees paid by such
person pursuant to subsection (a)(2).
``(e) Effect of Failure To Pay Fees.--Notwithstanding any
other requirement, a submission for prebroadcast advisory
review of a DTC advertisement submitted by a person subject
to fees under subsection (a) shall be considered incomplete
and shall not be accepted for review by the Secretary until
all fees owed by such person under this section have been
paid.
``(f) Effect of Inadequate Funding of Program.--
``(1) Initial funding.--If on November 1, 2007, or 120 days
after enactment of this provision, whichever is later, the
Secretary has not received at least $11,250,000 in advisory
review fees and operating reserve fees combined, the program
under this section shall not commence and all collected fees
shall be refunded.
``(2) Later fiscal years.--Beginning in fiscal year 2009,
if, on November 1 of the fiscal year, the combination of the
operating reserves, annual fee revenues from that fiscal
year, and unobligated fee revenues from prior fiscal years
falls below $9,000,000, adjusted for inflation (as described
in subsection (c)(1)), the program under this section shall
cease to exist, and the Secretary shall notify all
participants, retain any money from the unused advisory
review fees and the operating reserves needed to close down
the program under this section, and refund the remainder of
the unused fees and operating reserves. To the extent
required to close down the program under this section, the
Secretary shall first use unobligated advisory review fee
revenues from prior fiscal years, then the operating
reserves, and finally, unused advisory review fees from the
relevant fiscal year.
``(g) Crediting and Availability of Fees.--
``(1) In general.--Fees authorized under subsection (a) of
this section shall be collected and available for obligation
only to the extent and in the amount provided in advance in
appropriations Acts. Such fees are authorized to remain
available until expended. Such sums as may be necessary may
be transferred from the Food and Drug Administration salaries
and expenses appropriation account without fiscal year
limitation to such appropriation account for salaries and
expenses with such fiscal year limitation. The sums
transferred shall be available solely for the process for the
advisory review of prescription drug advertising.
``(2) Collections and appropriation acts.--
``(A) In general.--The fees authorized by this section--
``(i) shall be retained in each fiscal year in an amount
not to exceed the amount specified in appropriation Acts, or
otherwise made available for obligation for such fiscal year;
and
``(ii) shall be available for obligation only if the
amounts appropriated as budget authority for such fiscal year
are sufficient to support a number of full-time equivalent
review employees that is not fewer than the number of such
employees supported in fiscal year 2007.
``(B) Review employees.--For purposes of subparagraph
(A)(ii), the term `full-time equivalent review employees'
means the total combined number of full-time equivalent
employees in--
``(i) the Center for Drug Evaluation and Research, Division
of Drug Marketing, Advertising, and Communications, Food and
Drug Administration; and
``(ii) the Center for Biologics Evaluation and Research,
Advertising and Promotional Labeling Branch, Food and Drug
Administration.
``(3) Authorization of appropriations.--For each of the
fiscal years 2008 through 2012, there is authorized to be
appropriated for fees under this section an amount equal to
the total revenue amount determined under subsection (b) for
the fiscal year, as adjusted pursuant to subsection (c) and
paragraph (4) of this subsection, plus amounts collected for
the reserve fund under subsection (d).
``(4) Offset.--Any amount of fees collected for a fiscal
year under this section that exceeds the amount of fees
specified in appropriation Acts for such fiscal year shall be
credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
collected under this section pursuant to appropriation Acts
for a subsequent fiscal year.
``(h) Definitions.--For purposes of this subchapter:
``(1) The term `advisory review' means reviewing and
providing advisory comments on a proposed advertisement prior
to its initial public broadcast.
``(2) The term `advisory review fee' has the meaning
indicated for such term in subsection (a)(1)(D).
``(3) The term `carry over submission' means a submission
for an advisory review for which a fee was paid in one fiscal
year that is submitted for review in the following fiscal
year.
``(4) The term `direct-to-consumer television
advertisement' means an advertisement for a prescription drug
product as defined in section 735(3) intended to be displayed
on any television channel for less than 3 minutes.
``(5) The term `DTC advertisement' has the meaning
indicated for such term in subsection (a)(1)(A).
``(6) The term `operating reserve fee' has the meaning
indicated for such term in subsection (a)(2)(A).
``(7) The term `person' includes an individual,
partnership, corporation, and association, and any affiliate
thereof or successor in interest.
``(8) The term `prebroadcast advisory review' has the
meaning indicated for such term in subsection (a)(1)(A).
``(9) The term `process for the advisory review of
prescription drug advertising' means the activities necessary
to review and provide advisory comments on DTC advertisements
prior to public broadcast and, to the extent the Secretary
has additional staff resources available under the program
under this section that are not necessary for the advisory
review of DTC advertisements, the activities necessary to
review and provide advisory comments on other proposed
advertisements and promotional material prior to public
broadcast.
``(10) The term `resources allocated for the process for
the advisory review of prescription drug advertising' means
the expenses incurred in connection with the process for the
advisory review of prescription drug advertising for--
``(A) officers and employees of the Food and Drug
Administration, contractors of the Food and Drug
Administration, advisory committees, and costs related to
such officers, employees, and committees, and to contracts
with such contractors;
``(B) management of information, and the acquisition,
maintenance, and repair of computer resources;
``(C) leasing, maintenance, renovation, and repair of
facilities and acquisition, maintenance, and repair of
fixtures, furniture, scientific equipment, and other
necessary materials and supplies;
``(D) collection of fees under this section and accounting
for resources allocated for the advisory review of
prescription drug advertising; and
``(E) closing down the program under this section pursuant
to subsection (f)(2) if that becomes necessary.
``(11) The term `resubmission' means a subsequent
submission for advisory review of a direct-to-consumer
television advertisement that has been revised in response to
the Secretary's comments on an original submission. A
resubmission may not introduce significant new concepts or
creative themes into the television advertisement.
``(12) The term `submission for advisory review' means an
original submission of a direct-to-consumer television
advertisement for which the sponsor voluntarily requests
advisory comments before the advertisement is publicly
disseminated.''.
SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Report.--Beginning with fiscal year 2008,
not later than 120 days after the end of each fiscal year for
which fees are collected under part 2 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379g et seq.), the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall prepare and submit to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Health, Education, Labor, and Pensions of the Senate a report
concerning the progress of the Food and Drug Administration
in achieving the goals identified in the letters described in
section 502(4) of the Prescription Drug User Fee Amendments
of 2002 (Subtitle A of title V of Public Law 107-188) during
such fiscal year and the future plans of the Food and Drug
Administration for meeting the goals.
(b) Fiscal Report.--Beginning with fiscal year 2008, not
later than 120 days after the end of each fiscal year for
which fees are collected under the part described in
subsection (a), the Secretary shall prepare and submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of 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 such fiscal year.
(c) Reauthorization.--
(1) Consultation.--In developing recommendations to present
to the Congress
[[Page H7573]]
with respect to the goals, and plans for meeting the goals,
for the process for the review of human drug applications for
the first 5 fiscal years after fiscal year 2012, and for the
reauthorization of this part for such fiscal years, the
Secretary shall consult with--
(A) the Committee on Energy and Commerce of the House of
Representatives;
(B) the Committee on Health, Education, Labor, and Pensions
of the Senate;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer advocacy
groups; and
(F) the regulated industry.
(2) Public review of recommendations.--After negotiations
with the regulated industry and representatives of patient
and consumer advocacy groups, the Secretary shall--
(A) present the recommendations developed under paragraph
(1) to the congressional committees specified in such
paragraph;
(B) publish such recommendations in the Federal Register;
(C) provide for a period of 30 days for the public to
provide written comments on such recommendations;
(D) hold a meeting at which the public may present its
views on such recommendations; and
(E) after consideration of such public views and comments,
revise such recommendations as necessary.
(3) Transmittal of recommendations.--Not later than January
15, 2012, the Secretary shall transmit to Congress the
revised recommendations under paragraph (2), a summary of the
views and comments received under such paragraph, and any
changes made to the recommendations in response to such views
and comments.
(4) Public availability of minutes.--Before presenting the
recommendations developed under paragraphs (1) and (2) to the
Congress, the Secretary shall make publicly available, on the
public website of the Food and Drug Administration, the
minutes of all negotiations conducted under paragraph (1) or
(2), as applicable, between the Food and Drug Administration
and the regulated industry and representatives of patient and
consumer advocacy groups.
SEC. 106. SUNSET DATES.
The amendments made by sections 102, 103, and 104 cease to
be effective October 1, 2012.
TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
SEC. 201. SHORT TITLE; REFERENCES IN TITLE.
(a) Short Title.--This title may be cited as the ``Medical
Device User Fee Amendments of 2007''.
(b) References in Act.--Except as otherwise specified,
amendments made by this title to a section or other provision
of law are amendments to such section or other provision of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.).
Subtitle A--Fees Related to Medical Devices
SEC. 211. DEFINITIONS.
Section 737 (21 U.S.C. 379i) is amended--
(1) in paragraph (4)--
(A) in subparagraph (A), by striking ``or an efficacy
supplement,'' and inserting ``an efficacy supplement, or a
30-day notice,''; and
(B) by adding after subparagraph (E) the following:
``(F) The term `30-day notice' means a supplement to an
approved premarket application or premarket report under
section 515 that is limited to a request to make
modifications to manufacturing procedures or methods of
manufacture affecting the safety and effectiveness of the
device.'';
(2) by redesignating paragraphs (5), (6), (7), and (8) as
paragraphs (7), (8), (9), and (11), respectively;
(3) by inserting after paragraph (4), as amended by
paragraph (1) of this section, the following:
``(5) The term `request for classification information'
means a request made under section 513(g) for information
respecting the class in which a device has been classified or
the requirements applicable to a device.
``(6) The term `annual fee', with respect to periodic
reporting concerning a class III device, means the annual fee
associated with periodic reports required by a PMA approval
order (as described in section 814.82(a)(7) of title 21, Code
of Federal Regulations (or any successor regulation)).'';
(4) in paragraph (9), as so redesignated--
(A) by striking ``April of the preceding fiscal year'' and
inserting ``October of the preceding fiscal year''; and
(B) by striking ``April 2002'' and inserting ``October
2001'';
(5) by inserting after paragraph (9), as so amended, the
following:
``(10) The term `person' includes an affiliate thereof.'';
and
(6) by inserting after paragraph (11), as redesignated by
paragraph (2) of this section, the following:
``(12) The term `establishment subject to registration'
means an establishment that is required to register with the
Secretary under section 510 and is one of the following types
of establishments:
``(A) Manufacturer.--An establishment that makes by any
means any article that is a device, as defined in section
201(h), including an establishment that sterilizes or
otherwise makes such article for or on behalf of a
specification developer or any other person.
``(B) Single-use device reprocessor.--An establishment that
performs manufacturing operations on a single-use device.
``(C) Specification developer.--An establishment that
develops specifications for a device that is distributed
under the establishment's name but which performs no
manufacturing, including an establishment that, in addition
to developing specifications, also arranges for the
manufacturing of devices labeled with another establishment's
name by a contract manufacturer.''.
SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES.
(a) Types of Fees.--
(1) In general.--The designation and heading of paragraph
(2) of section 738(a) (21 U.S.C. 379j(a)(2)) are amended to
read as follows:
``(2) Premarket application, premarket report, supplement,
and submission fee, and annual fee for periodic reporting
concerning a class iii device.--''.
(2) Fee amounts.--Section 738(a)(2)(A) (21 U.S.C.
379j(a)(2)(A)) is amended--
(A) in clause (iii), by striking ``a fee equal to the fee
that applies'' and inserting ``a fee equal to 75 percent of
the fee that applies'';
(B) in clause (iv), by striking ``21.5 percent'' and
inserting ``15 percent'';
(C) in clause (v), by striking ``7.2 percent'' and
inserting ``7 percent'';
(D) by redesignating clauses (vi) and (vii) as clauses
(vii) and (viii), respectively;
(E) by inserting after clause (v), as amended by this
paragraph, the following:
``(vi) For a 30-day notice, a fee equal to 1.6 percent of
the fee that applies under clause (i).'';
(F) in clause (viii), as so redesignated, by striking
``1.42 percent'' and inserting ``1.84 percent''; and
(G) by inserting after such clause (viii) the following:
``(ix) For a request for classification information, a fee
equal to 1.35 percent of the fee that applies under clause
(i).
``(x) For periodic reporting concerning a class III device,
the annual fee shall be equal to 3.5 percent of the fee that
applies under clause (i).''.
(3) Payment.--Section 738(a)(2)(C) (21 U.S.C.
379j(a)(2)(C)) is amended to read as follows:
``(C) Payment.--The fee required by subparagraph (A) shall
be due upon submission of the premarket application,
premarket report, supplement, premarket notification
submission, 30-day notice, request for classification
information, or periodic reporting concerning a class III
device. Applicants submitting portions of applications
pursuant to section 515(c)(3) shall pay such fees upon
submission of the first portion of such applications.''.
(4) Refunds.--Section 738(a)(2)(D) (21 U.S.C.
379j(a)(2)(D)) is amended by adding after clause (iii) the
following:
``(iv) Modular applications withdrawn before first
action.--The Secretary shall refund 75 percent of the
application fee paid for a modular application submitted
under section 515(c)(4) that is withdrawn before a second
module is submitted and before a first action on the first
module. If the modular application is withdrawn after a
second or subsequent module is submitted but before any first
action, the Secretary may return a portion of the fee. The
amount of refund, if any, shall be based on the level of
effort already expended on the review of the modules
submitted.''.
(5) Annual establishment registration fee.--Section 738(a)
(21 U.S.C. 379j(a)) is amended by adding after paragraph (2)
the following:
``(3) Annual establishment registration fee.--
``(A) In general.--Except as provided in subparagraph (B),
each establishment subject to registration shall be subject
to a fee for each initial or annual registration under
section 510 beginning with its registration for fiscal year
2008.
``(B) Exception.--No fee shall be required under
subparagraph (A) for an establishment operated by a State or
Federal governmental entity or an Indian tribe (as defined in
the Indian Self Determination and Educational Assistance
Act), unless a device manufactured by the establishment is to
be distributed commercially.
``(C) Payment.--The fee required under subparagraph (A)
shall be due once each fiscal year, upon the initial
registration of the establishment or upon the annual
registration under section 510.''.
(b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is
amended to read as follows:
``(b) Fee amounts.--Except as provided in subsections (c),
(d), and (e), the fees under subsection (a) shall be based on
the following fee amounts:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
Fee Type Year 2008 Year 2009 Year 2010 Year 2011 Year 2012
----------------------------------------------------------------------------------------------------------------
Premarket Application................................... $185,000 $200,725 $217,787 $236,298 $256,384
[[Page H7574]]
Establishment Registration.............................. $1,706 $1,851 $2,008 $2,179 $2,364.''.
----------------------------------------------------------------------------------------------------------------
(c) Annual Fee Setting.--
(1) In general.--Section 738(c) (21 U.S.C. 379j(c)(1)) is
amended--
(A) in the subsection heading, by striking ``Annual Fee
Setting'' and inserting ``Annual Fee Setting''; and
(B) in paragraph (1), by striking the last sentence.
(2) Adjustment of annual establishment fee.--Section 738(c)
(21 U.S.C. 379j(c)), as amended by paragraph (1), is further
amended--
(A) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively;
(B) by inserting after paragraph (1) the following:
``(2) Adjustment.--
``(A) In general.--When setting fees for fiscal year 2010,
the Secretary may increase the fee under subsection (a)(3)(A)
(applicable to establishments subject to registration) only
if the Secretary estimates that the number of establishments
submitting fees for fiscal year 2009 is less than 12,250. The
percentage increase shall be the percentage by which the
estimate of establishments submitting fees in fiscal year
2009 is less than 12,750, but in no case may the percentage
increase be more than 8.5 percent over that specified in
subsection (b) for fiscal year 2010. If the Secretary makes
any adjustment to the fee under subsection (a)(3)(A) for
fiscal year 2010, then such fee for fiscal years 2011 and
2012 shall be adjusted so that such fee for fiscal year 2011
is equal to the adjusted fee for fiscal year 2010 increased
by 8.5 percent, and such fee for fiscal year 2012 is equal to
the adjusted fee for fiscal year 2011 increased by 8.5
percent.
``(B) Publication.--For any adjustment made under
subparagraph (A), the Secretary shall publish in the Federal
Register the Secretary's determination to make the adjustment
and the rationale for the determination.''; and
(C) in paragraph (4), as redesignated by this paragraph, in
subparagraph (A)--
(i) by striking ``For fiscal years 2006 and 2007, the
Secretary'' and inserting ``The Secretary''; and
(ii) by striking ``for the first month of fiscal year
2008'' and inserting ``for the first month of the next fiscal
year''.
(d) Small Businesses; Fee Waiver and Fee Reduction
Regarding Premarket Approval.--
(1) In general.--Section 738(d)(1) (21 U.S.C. 379j(d)(1))
is amended--
(A) by striking ``, partners, and parent firms''; and
(B) by striking ``clauses (i) through (vi) of subsection
(a)(2)(A)'' and inserting ``clauses (i) through (v) and
clauses (vii), (ix), and (x) of subsection (a)(2)(A)''.
(2) Rules relating to premarket approval fees.--
(A) Definition.--Section 738(d)(2)(A) (21 U.S.C.
379j(d)(2)(A)) is amended by striking ``, partners, and
parent firms''.
(B) Evidence of qualification.--Section 738(d)(2)(B) (21
U.S.C. 379j(d)(2)(B)) is amended--
(i) by striking ``(B) Evidence of qualification.--An
applicant'' and inserting the following:
``(B) Evidence of qualification.--
``(i) In general.--An applicant'';
(ii) by striking ``The applicant shall support its claim''
and inserting the following:
``(ii) Firms submitting tax returns to the united states
internal revenue service.--The applicant shall support its
claim'';
(iii) by striking ``, partners, and parent firms'' each
place it appears;
(iv) by striking the last sentence and inserting ``If no
tax forms are submitted for any affiliate, the applicant
shall certify that the applicant has no affiliates.''; and
(v) by adding at the end the following:
``(iii) Firms not submitting tax returns to the united
states internal revenue service.--In the case of an applicant
that has not previously submitted a Federal income tax
return, the applicant and each of its affiliates shall
demonstrate that it meets the definition under subparagraph
(A) by submission of a signed certification, in such form as
the Secretary may direct through a notice published in the
Federal Register, that the applicant or affiliate meets the
criteria for a small business and a certification, in
English, from the national taxing authority of the country in
which the applicant or, if applicable, affiliate is
headquartered. The certification from such taxing authority
shall bear the official seal of such taxing authority and
shall provide the applicant's or affiliate's gross receipts
and sales for the most recent year in both the local currency
of such country and in United States dollars, the exchange
rate used in converting such local currency to dollars, and
the dates during which these receipts and sales were
collected. The applicant shall also submit a statement signed
by the head of the applicant's firm or by its chief financial
officer that the applicant has submitted certifications for
all of its affiliates, or that the applicant has no
affiliates.''.
(3) Reduced fees.--Section 738(d)(2)(C) (21 U.S.C.
379j(d)(2)(C)) is amended to read as follows:
``(C) Reduced fees.--Where the Secretary finds that the
applicant involved meets the definition under subparagraph
(A), the fees established under subsection (c)(1) may be paid
at a reduced rate of--
``(i) 25 percent of the fee established under such
subsection for a premarket application, a premarket report, a
supplement (other than a 30-day notice), or periodic
reporting concerning a class III device; and
``(ii) 50 percent of the fee established under such
subsection for a 30-day notice or a request for
classification information.''.
(e) Small Businesses; Fee Reduction Regarding Premarket
Notification Submissions.--
(1) In general.--Section 738(e)(1) (21 U.S.C. 379j(e)(1))
is amended--
(A) by striking ``2004'' and inserting ``2008''; and
(B) by striking ``(a)(2)(A)(vii)'' and inserting
``(a)(2)(A)(viii)''.
(2) Rules relating to premarket notification submissions.--
(A) Definition.--Section 738(e)(2)(A) (21 U.S.C.
379j(e)(2)(A)) is amended by striking ``, partners, and
parent firms''.
(B) Evidence of qualification.--Section 738(e)(2)(B) (21
U.S.C. 379j(e)(2)(A)) is amended--
(i) by striking ``(B) Evidence of qualification.--An
applicant'' and inserting the following:
``(B) Evidence of qualification.--
``(i) In general.--An applicant'';
(ii) by striking ``The applicant shall support its claim''
and inserting the following:
``(ii) Firms submitting tax returns to the united states
internal revenue service.--The applicant shall support its
claim'';
(iii) by striking ``, partners, and parent firms'' each
place it appears;
(iv) by striking the last sentence and inserting ``If no
tax forms are submitted for any affiliate, the applicant
shall certify that the applicant has no affiliates.''; and
(v) by adding at the end the following:
``(iii) Firms not submitting tax returns to the united
states internal revenue service.--In the case of an applicant
that has not previously submitted a Federal income tax
return, the applicant and each of its affiliates shall
demonstrate that it meets the definition under subparagraph
(A) by submission of a signed certification, in such form as
the Secretary may direct through a notice published in the
Federal Register, that the applicant or affiliate meets the
criteria for a small business and a certification, in
English, from the national taxing authority of the country in
which the applicant or, if applicable, affiliate is
headquartered. The certification from such taxing authority
shall bear the official seal of such taxing authority and
shall provide the applicant's or affiliate's gross receipts
and sales for the most recent year in both the local currency
of such country and in United States dollars, the exchange
rate used in converting such local currency to dollars, and
the dates during which these receipts and sales were
collected. The applicant shall also submit a statement signed
by the head of the applicant's firm or by its chief financial
officer that the applicant has submitted certifications for
all of its affiliates, or that the applicant has no
affiliates.''.
(3) Reduced fees.--Section 738(e)(2)(C) (21 U.S.C.
379j(e)(2)(C)) is amended to read as follows:
``(C) Reduced fees.--For fiscal year 2008 and each
subsequent fiscal year, where the Secretary finds that the
applicant involved meets the definition under subparagraph
(A), the fee for a premarket notification submission may be
paid at 50 percent of the fee that applies under subsection
(a)(2)(A)(viii), and as established under subsection
(c)(1).''.
(f) Effect of Failure To Pay Fees.--Section 738(f) (21
U.S.C. 379j(f)) is amended to read as follows:
``(f) Effect of Failure To Pay Fees.--
``(1) No acceptance of submissions.--A premarket
application, premarket report, supplement, premarket
notification submission, 30-day notice, request for
classification information, or periodic reporting concerning
a class III device submitted by a person subject to fees
under subsection (a)(2) and (a)(3) shall be considered
incomplete and shall not be accepted by the Secretary until
all fees owed by such person have been paid.
``(2) No registration.--Registration information submitted
under section 510 by an establishment subject to registration
shall be considered incomplete and shall not be accepted by
the Secretary until the registration fee under subsection
(a)(3) owed for the establishment has been paid. Until the
fee is paid and the registration is complete, the
establishment is deemed to have failed to register in
accordance with section 510.''.
(g) Conditions.--Section 738(g) (21 U.S.C. 379j(g)) is
amended--
(1) in paragraph (1)(D)--
(A) in the matter preceding clause (i), by striking ``For
fiscal year 2007'' and inserting ``For fiscal year 2007 and
for each subsequent year'';
[[Page H7575]]
(B) in clause (i), by striking ``applicable to fiscal year
2007'' and inserting ``applicable to such fiscal year''; and
(C) in clause (ii)--
(i) by striking ``subparagraph (C)'' and inserting ``this
subparagraph''; and
(ii) by striking ``for fiscal year 2006'' and inserting
``for the previous fiscal year''; and
(2) by amending paragraph (2) to read as follows:
``(2) Authority.--If the Secretary does not assess fees
under subsection (a) during any portion of a fiscal year
because of subparagraph (C) or (D) of paragraph (1) and if at
a later date in such fiscal year the Secretary may assess
such fees, the Secretary may assess and collect such fees,
without any modification in the rate for premarket
applications, supplements, premarket reports, premarket
notification submissions, 30-day notices, requests for
classification information, periodic reporting concerning a
class III device, and establishment registrations at any time
in such fiscal year, notwithstanding the provisions of
subsection (a) relating to the date fees are to be paid.''.
(h) Crediting and Availability of Fees.--
(1) Authorization of appropriations.--Section 738(h)(3) (21
U.S.C. 379j(h)(3)) is amended to read as follows:
``(3) Authorizations of appropriations.--There are
authorized to be appropriated for fees under this section--
``(A) $48,431,000 for fiscal year 2008;
``(B) $52,547,000 for fiscal year 2009;
``(C) $57,014,000 for fiscal year 2010;
``(D) $61,860,000 for fiscal year 2011; and
``(E) $67,118,000 for fiscal year 2012.''.
(2) Offset.--Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is
amended to read as follows:
``(4) Offset.--If the cumulative amount of fees collected
during fiscal years 2008, 2009, and 2010, added to the amount
estimated to be collected for fiscal year 2011, which
estimate shall be based upon the amount of fees received by
the Secretary through June 30, 2011, exceeds the amount of
fees specified in aggregate in paragraph (3) for these four
fiscal years, the aggregate amount in excess shall be
credited to the appropriation account of the Food and Drug
Administration as provided in paragraph (1), and shall be
subtracted from the amount of fees that would otherwise be
authorized to be collected under this section pursuant to
appropriation Acts for fiscal year 2012.''.
SEC. 213. ANNUAL REPORTS.
Beginning with fiscal year 2008, the Secretary shall
prepare and submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report
concerning--
(1) the progress of the Food and Drug Administration in
achieving the goals identified in the letters from the
Secretary of Health and Human Services to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate, as set forth in the Congressional Record during such
fiscal year, and the future plans of the Food and Drug
Administration for meeting the goals, not later than 60 days
after the end of each fiscal year during which fees are
collected under part 3 of chapter VII of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379i et seq.); and
(2) 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 during such fiscal year
(including a description of the use of such fees for
postmarket safety activities), not later than 120 days after
the end of each fiscal year during which fees are collected
under the medical device user-fee program reauthorized by
this title.
SEC. 214. CONSULTATION.
(a) In General.--In developing recommendations to the
Congress for the goals and plans for meeting the goals for
the process for the review of medical device applications for
fiscal years after fiscal year 2012, and for the
reauthorization of sections 737 and 738 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379i, 379j), the Secretary
of Health and Human Services (referred to in this section as
the ``Secretary'') shall consult with the Committee on Energy
and Commerce of the House of Representatives, the Committee
on Health, Education, Labor, and Pensions of the Senate,
appropriate scientific and academic experts, health care
professionals, representatives of patient and consumer
advocacy groups, and the regulated industry.
(b) Recommendations.--The Secretary shall publish in the
Federal Register recommendations under subsection (a), after
negotiations with the regulated industry and patient and
consumer advocacy groups; shall present such recommendations
to the congressional committees specified in such subsection;
shall hold a meeting at which the public may present its
views on such recommendations; and shall provide for a period
of 30 days for the public to provide written comments on such
recommendations.
SEC. 215. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS FOR
POSTMARKET SAFETY INFORMATION.
For the purpose of collecting, developing, reviewing, and
evaluating postmarket safety information on medical devices,
there are authorized to be appropriated to the Food and Drug
Administration, in addition to the amounts authorized by
other provisions of law for such purpose, $7,100,000 for
fiscal year 2008, and for each of the fiscal years 2009
through 2012, $7,100,000 increased by the amount necessary to
offset the effects of inflation occurring after October 1,
2007.
SEC. 216. EFFECTIVE DATE.
The amendments made by this title shall take effect on the
date of the enactment of this title, except that fees shall
be assessed for all premarket applications, premarket
reports, supplements, and premarket notification submissions
received on or after October 1, 2007, regardless of the date
of enactment.
SEC. 217. SUNSET CLAUSE.
The amendments made by this title cease to be effective
October 1, 2012, except that section 213 (regarding annual
reports) ceases to be effective January 31, 2013.
Subtitle B--Amendments Regarding Regulation of Medical Devices
SEC. 221. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF
PREMARKET NOTIFICATION.
Section 523(c) (21 U.S.C. 360m(c)) is amended by striking
``2007'' and inserting ``2012''.
SEC. 222. REGISTRATION.
(a) Annual Registration of Producers of Drugs and
Devices.--Section 510(b) (21 U.S.C. 360(b)) is amended--
(1) by striking ``On or before'' and inserting ``(1) On or
before'';
(2) by striking ``or a device or devices''; and
(3) by adding at the end the following:
``(2) During the period beginning on October 1 and ending
on December 31 of each year, every person who owns or
operates any establishment in any State engaged in the
manufacture, preparation, propagation, compounding, or
processing of a device or devices shall register with the
Secretary his name, places of business, and all such
establishments.''.
(b) Registration of Foreign Establishments.--Section
510(i)(1) (21 U.S.C. 360(i)(1)) is amended by striking ``On
or before December 31'' and all that follows and inserting
the following: ``Any establishment within any foreign country
engaged in the manufacture, preparation, propagation,
compounding, or processing of a drug or device that is
imported or offered for import into the United States shall,
through electronic means in accordance with the criteria of
the Secretary--
``(A) upon first engaging in any such activity, immediately
register with the Secretary the name and place of business of
the establishment, the name of the United States agent for
the establishment, the name of each importer of such drug or
device in the United States that is known to the
establishment, and the name of each person who imports or
offers for import such drug or device to the United States
for purposes of importation; and
``(B) each establishment subject to the requirements of
subparagraph (A) shall thereafter--
``(i) with respect to drugs, register with the Secretary on
or before December 31 of each year; and
``(ii) with respect to devices, register with the Secretary
during the period beginning on October 1 and ending on
December 31 of each year.''.
SEC. 223. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED,
PREPARED, PROPAGATED, AND COMPOUNDED BY
REGISTRANTS; STATEMENTS; ACCOMPANYING
DISCLOSURES.
Section 510(j)(2) (21 U.S.C. 360(j)(2)) is amended, in the
matter preceding subparagraph (A), by striking ``Each
person'' and all that follows through ``the following
information:'' and inserting ``Each person who registers with
the Secretary under this section shall report to the
Secretary, with regard to drugs once during the month of June
of each year and once during the month of December of each
year, and with regard to devices once each year during the
period beginning on October 1 and ending on December 31, the
following information:''.
SEC. 224. ELECTRONIC REGISTRATION AND LISTING.
Section 510(p) (21 U.S.C. 360(p)) is amended to read as
follows:
``(p)(1) Registrations and listings under this section
(including the submission of updated information) shall be
submitted to the Secretary by electronic means unless the
Secretary grants a request for waiver of such requirement
because use of electronic means is not reasonable for the
person requesting such waiver.
``(2) With regard to any establishment engaged in the
manufacture, preparation, propagation, compounding, or
processing of a device, the registration and listing
information required by this section shall be submitted to
the Secretary by electronic means, unless the Secretary
grants a waiver because electronic registration and listing
is not reasonable for the person requesting such waiver.''.
SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.
(a) In General.--The Comptroller General of the United
States shall conduct a study on the appropriate use of the
process under section 510(k) of the Federal Food, Drug, and
Cosmetic Act as part of the device classification process to
determine whether a new device is as safe and effective as a
classified device.
(b) Consideration.--In determining the effectiveness of the
premarket notification and classification authority under
section 510(k) and subsections (f) and (i) of section 513,
the study under subsection (a) shall consider the Secretary's
evaluation of the respective intended uses and technologies
of such devices, including the effectiveness of the
Secretary's comparative assessment of technological
characteristics such as device
[[Page H7576]]
materials, principles of operations, and power sources.
(c) Report.--Not later than 1 year after the date of the
enactment of this Act, the Comptroller General shall complete
the study under subsection (a) and submit to the Congress a
report on the results of such study.
SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM.
Section 519 (21 U.S.C. 360i) is amended--
(1) by redesignating subsection (f) as subsection (g); and
(2) by inserting after subsection (e) the following:
``Unique Device Identification System
``(f) The Secretary shall promulgate regulations
establishing a unique device identification system for
medical devices requiring the labeling of devices to bear a
unique identifier.''.
SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DEVICES.
Subparagraph (B) of section 519(a)(1) (21 U.S.C.
360i(a)(1)) is amended by striking ``were to recur;'' and
inserting the following: ``were to recur, which report under
this subparagraph--
``(i) shall be submitted in accordance with part 803 of
title 21, Code of Federal Regulations (or successor
regulations), if the device involved is--
``(I) a class III device;
``(II) a class II device that is permanently implantable,
is life supporting, or is life sustaining; or
``(III) a type of device that the Secretary has by
regulation determined should be subject to such part 803 in
order to protect the public health; or
``(ii) shall, if the device is not subject to clause (i),
be submitted in accordance with criteria established by the
Secretary for reports made pursuant to this clause, which
criteria shall require the reports to be in summary form and
made on a quarterly basis;''.
SEC. 228. INSPECTIONS BY ACCREDITED PERSONS.
Section 704(g) (21 U.S.C. 374(g)) is amended--
(1) in paragraph (1), by striking ``Not later than one year
after the date of the enactment of this subsection, the
Secretary'' and inserting ``The Secretary'';
(2) in paragraph (2), by--
(A) striking ``Not later than 180 days after the date of
enactment of this subsection, the Secretary'' and inserting
``The Secretary''; and
(B) striking the fifth sentence;
(3) in paragraph (3), by adding at the end the following:
``(F) Such person shall notify the Secretary of any
withdrawal, suspension, restriction, or expiration of
certificate of conformance with the quality systems standard
referred to in paragraph (7) for any device establishment
that such person inspects under this subsection not later
than 30 days after such withdrawal, suspension, restriction,
or expiration.
``(G) Such person may conduct audits to establish
conformance with the quality systems standard referred to in
paragraph (7).'';
(4) by amending paragraph (6) to read as follows:
``(6)(A) Subject to subparagraphs (B) and (C), a device
establishment is eligible for inspection by persons
accredited under paragraph (2) if the following conditions
are met:
``(i) The Secretary classified the results of the most
recent inspection of the establishment as `no action
indicated' or `voluntary action indicated'.
``(ii) With respect to inspections of the establishment to
be conducted by an accredited person, the owner or operator
of the establishment submits to the Secretary a notice that--
``(I) provides the date of the last inspection of the
establishment by the Secretary and the classification of that
inspection;
``(II) states the intention of the owner or operator to use
an accredited person to conduct inspections of the
establishment;
``(III) identifies the particular accredited person the
owner or operator intends to select to conduct such
inspections; and
``(IV) includes a certification that, with respect to the
devices that are manufactured, prepared, propagated,
compounded, or processed in the establishment--
``(aa) at least 1 of such devices is marketed in the United
States; and
``(bb) at least 1 of such devices is marketed, or is
intended to be marketed, in 1 or more foreign countries, 1 of
which countries certifies, accredits, or otherwise recognizes
the person accredited under paragraph (2) and identified
under subclause (III) as a person authorized to conduct
inspections of device establishments.
``(B)(i) Except with respect to the requirement of
subparagraph (A)(i), a device establishment is deemed to have
clearance to participate in the program and to use the
accredited person identified in the notice under subparagraph
(A)(ii) for inspections of the establishment unless the
Secretary, not later than 30 days after receiving such
notice, issues a response that--
``(I) denies clearance to participate as provided under
subparagraph (C); or
``(II) makes a request under clause (ii).
``(ii) The Secretary may request from the owner or operator
of a device establishment in response to the notice under
subparagraph (a)(ii) with respect to the establishment, or
from the particular accredited person identified in such
notice--
``(I) compliance data for the establishment in accordance
with clause (iii)(I); or
``(II) information concerning the relationship between the
owner or operator of the establishment and the accredited
person identified in such notice in accordance with clause
(iii)(II).
The owner or operator of the establishment, or such
accredited person, as the case may be, shall respond to such
a request not later than 60 days after receiving such
request.
``(iii)(I) The compliance data to be submitted by the owner
or operation of a device establishment in response to a
request under clause (ii)(I) are data describing whether the
quality controls of the establishment have been sufficient
for ensuring consistent compliance with current good
manufacturing practice within the meaning of section 501(h)
and with other applicable provisions of this Act. Such data
shall include complete reports of inspectional findings
regarding good manufacturing practice or other quality
control audits that, during the preceding 2-year period, were
conducted at the establishment by persons other than the
owner or operator of the establishment, together with all
other compliance data the Secretary deems necessary. Data
under the preceding sentence shall demonstrate to the
Secretary whether the establishment has facilitated
consistent compliance by promptly correcting any compliance
problems identified in such inspections.
``(II) A request to an accredited person under clause
(ii)(II) may not seek any information that is not required to
be maintained by such person in records under subsection
(f)(1).
``(iv) A device establishment is deemed to have clearance
to participate in the program and to use the accredited
person identified in the notice under subparagraph (A)(ii)
for inspections of the establishment unless the Secretary,
not later than 60 days after receiving the information
requested under clause (ii), issues a response that denies
clearance to participate as provided under subparagraph (C).
``(C)(i) The Secretary may deny clearance to a device
establishment if the Secretary has evidence that the
certification under subparagraph (A)(ii)(IV) is untrue and
the Secretary provides to the owner or operator of the
establishment a statement summarizing such evidence.
``(ii) The Secretary may deny clearance to a device
establishment if the Secretary determines that the
establishment has failed to demonstrate consistent compliance
for purposes of subparagraph (B)(iii)(I) and the Secretary
provides to the owner or operator of the establishment a
statement of the reasons for such determination.
``(iii)(I) The Secretary may reject the selection of the
accredited person identified in the notice under subparagraph
(A)(ii) if the Secretary provides to the owner or operator of
the establishment a statement of the reasons for such
rejection. Reasons for the rejection may include that the
establishment or the accredited person, as the case may be,
has failed to fully respond to the request, or that the
Secretary has concerns regarding the relationship between the
establishment and such accredited person.
``(II) If the Secretary rejects the selection of an
accredited person by the owner or operator of a device
establishment, the owner or operator may make an additional
selection of an accredited person by submitting to the
Secretary a notice that identifies the additional selection.
Clauses (i) and (ii) of subparagraph (B), and subclause (I)
of this clause, apply to the selection of an accredited
person through a notice under the preceding sentence in the
same manner and to the same extent as such provisions apply
to a selection of an accredited person through a notice under
subparagraph (A)(ii).
``(iv) In the case of a device establishment that is denied
clearance under clause (i) or (ii) or with respect to which
the selection of the accredited person is rejected under
clause (iii), the Secretary shall designate a person to
review the statement of reasons, or statement summarizing
such evidence, as the case may be, of the Secretary under
such clause if, during the 30-day period beginning on the
date on which the owner or operator of the establishment
receives such statement, the owner or operator requests the
review. The review shall commence not later than 30 days
after the owner or operator requests the review, unless the
Secretary and the owner or operator otherwise agree.'';
(5) in paragraph (7)--
(A) in subparagraph (A), by striking ``(A) Persons'' and
all that follows through the end and inserting the following:
``(A) Persons accredited under paragraph (2) to conduct
inspections shall record in writing their inspection
observations and shall present the observations to the device
establishment's designated representative and describe each
observation. Additionally, such accredited person shall
prepare an inspection report in a form and manner designated
by the Secretary to conduct inspections, taking into
consideration the goals of international harmonization of
quality systems standards. Any official classification of the
inspection shall be determined by the Secretary.''; and
(B) by adding at the end the following:
``(F) For the purpose of setting risk-based inspectional
priorities, the Secretary shall accept voluntary submissions
of reports of audits assessing conformance with appropriate
quality systems standards set by the International
Organization for Standardization (ISO) and identified by the
Secretary in
[[Page H7577]]
public notice. If the owner or operator of an establishment
elects to submit audit reports under this subparagraph, the
owner or operator shall submit all such audit reports with
respect to the establishment during the preceding 2-year
periods.''; and
(6) in paragraph (10)(C)(iii), by striking ``based'' and
inserting ``base''.
SEC. 229. STUDY OF NOSOCOMIAL INFECTIONS RELATING TO MEDICAL
DEVICES.
(a) In General.--The Comptroller General of the United
States shall conduct a study on--
(1) the number of nosocomial infections attributable to new
and reused medical devices; and
(2) the causes of such nosocomial infections, including the
following:
(A) Reprocessed single use devices.
(B) Handling of sterilized medical devices.
(C) In-hospital sterilization of medical devices.
(D) Health care professionals' practices for patient
examination and treatment.
(E) Hospital-based policies and procedures for infection
control and prevention.
(F) Hospital-based practices for handling of medical waste.
(G) Other causes.
(b) Report.--Not later than 1 year after the date of the
enactment of this Act, the Comptroller General shall complete
the study under subsection (a) and submit to the Congress a
report on the results of such study.
(c) Definition.--In this section, the term ``nosocomial
infection'' means an infection that is acquired while an
individual is a patient at a hospital and was neither present
nor incubating in the patient prior to receiving services in
the hospital.
TITLE III--PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007
SEC. 301. SHORT TITLE.
This title may be cited as the ``Pediatric Medical Device
Safety and Improvement Act of 2007''.
SEC. 302. TRACKING PEDIATRIC DEVICE APPROVALS.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by inserting after section 515
the following:
``SEC. 515A. PEDIATRIC USES OF DEVICES.
``(a) New Devices.--
``(1) In general.--A person that submits to the Secretary
an application under section 520(m), or an application (or
supplement to an application) or a product development
protocol under section 515, shall include in the application
or protocol the information described in paragraph (2).
``(2) Required information.--The application or protocol
described in paragraph (1) shall include, with respect to the
device for which approval is sought and if readily
available--
``(A) a description of any pediatric subpopulations that
suffer from the disease or condition that the device is
intended to treat, diagnose, or cure; and
``(B) the number of affected pediatric patients.
``(3) Annual report.--Not later than 18 months after the
date of enactment of this section, and annually thereafter,
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 includes--
``(A) the number of devices approved in the year preceding
the year in which the report is submitted, for which there is
a pediatric subpopulation that suffers from the disease or
condition that the device is intended to treat, diagnose, or
cure;
``(B) the number of devices approved in the year preceding
the year in which the report is submitted, labeled for use in
pediatric patients;
``(C) the number of pediatric devices approved in the year
preceding the year in which the report is submitted, exempted
from a fee pursuant to section 738(a)(2)(B)(v); and
``(D) the review time for each device described in
subparagraphs (A), (B), and (C).
``(b) Determination of Pediatric Effectiveness Based on
Similar Course of Disease or Condition or Similar Effect of
Device on Adults.--
``(1) In general.--If the course of the disease or
condition and the effects of the device are sufficiently
similar in adults and pediatric patients, the Secretary may
conclude that adult data may be used to support a
determination of a reasonable assurance of effectiveness in
pediatric populations, as appropriate.
``(2) Extrapolation between subpopulations.--A study may
not be needed in each pediatric subpopulation if data from
one subpopulation can be extrapolated to another
subpopulation.
``(c) Pediatric Subpopulation.--For purposes of this
section, the term `pediatric subpopulation' has the meaning
given the term in section 520(m)(6)(E)(ii).''.
SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.
(a) In General.--Section 520(m) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (3), by striking ``No'' and inserting
``Except as provided in paragraph (6), no'';
(2) in paragraph (5)--
(A) by inserting ``, if the Secretary has reason to believe
that the requirements of paragraph (6) are no longer met,''
after ``public health''; and
(B) by adding at the end the following: ``If the person
granted an exemption under paragraph (2) fails to demonstrate
continued compliance with the requirements of this
subsection, the Secretary may suspend or withdraw the
exemption from the effectiveness requirements of sections 514
and 515 for a humanitarian device only after providing notice
and an opportunity for an informal hearing.''; and
(3) by striking paragraph (6) and inserting after paragraph
(5) the following new paragraphs:
``(6)(A) Except as provided in subparagraph (D), the
prohibition in paragraph (3) shall not apply with respect to
a person granted an exemption under paragraph (2) if each of
the following conditions apply:
``(i)(I) The device with respect to which the exemption is
granted is intended for the treatment or diagnosis of a
disease or condition that occurs in pediatric patients or in
a pediatric subpopulation, and such device is labeled for use
in pediatric patients or in a pediatric subpopulation in
which the disease or condition occurs.
``(II) The device was not previously approved under this
subsection for the pediatric patients or the pediatric
subpopulation described in subclause (I) prior to the date of
enactment of the Pediatric Medical Device Safety and
Improvement Act of 2007.
``(ii) During any calendar year, the number of such devices
distributed during that year does not exceed the annual
distribution number specified by the Secretary when the
Secretary grants such exemption. The annual distribution
number shall be based on the number of individuals affected
by the disease or condition that such device is intended to
treat, diagnose, or cure, and of that number, the number of
individuals likely to use the device, and the number of
devices reasonably necessary to treat such individuals. In no
case shall the annual distribution number exceed the number
identified in paragraph (2)(A).
``(iii) Such person immediately notifies the Secretary if
the number of such devices distributed during any calendar
year exceeds the annual distribution number referred to in
clause (ii).
``(iv) The request for such exemption is submitted on or
before October 1, 2013.
``(B) The Secretary may inspect the records relating to the
number of devices distributed during any calendar year of a
person granted an exemption under paragraph (2) for which the
prohibition in paragraph (3) does not apply.
``(C) A person may petition the Secretary to modify the
annual distribution number specified by the Secretary under
subparagraph (A)(ii) with respect to a device if additional
information on the number of individuals affected by the
disease or condition arises, and the Secretary may modify
such number but in no case shall the annual distribution
number exceed the number identified in paragraph (2)(A).
``(D) If a person notifies the Secretary, or the Secretary
determines through an inspection under subparagraph (B), that
the number of devices distributed during any calendar year
exceeds the annual distribution number, as required under
subparagraph (A)(iii), and modified under subparagraph (C),
if applicable, then the prohibition in paragraph (3) shall
apply with respect to such person for such device for any
sales of such device after such notification.
``(E)(i) In this subsection, the term `pediatric patients'
means patients who are 21 years of age or younger at the time
of the diagnosis or treatment.
``(ii) In this subsection, the term `pediatric
subpopulation' means 1 of the following populations:
``(I) Neonates.
``(II) Infants.
``(III) Children.
``(IV) Adolescents.
``(7) The Secretary shall refer any report of an adverse
event regarding a device for which the prohibition under
paragraph (3) does not apply pursuant to paragraph (6)(A)
that the Secretary receives to the Office of Pediatric
Therapeutics, established under section 6 of the Best
Pharmaceuticals for Children Act (Public Law 107-109). In
considering the report, the Director of the Office of
Pediatric Therapeutics, in consultation with experts in the
Center for Devices and Radiological Health, shall provide for
periodic review of the report by the Pediatric Advisory
Committee, including obtaining any recommendations of such
committee regarding whether the Secretary should take action
under this Act in response to the report.
``(8) In consultation with the Office of Pediatric
Therapeutics and the Center for Devices and Radiological
Health, the Secretary shall provide for an annual review by
the Pediatric Advisory Committee of all devices described in
paragraph (6) to ensure that the exemption under paragraph
(2) remains appropriate for the pediatric populations for
which it is granted.''.
(b) Report.--Not later than January 1, 2012, the
Comptroller General of the United States 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 on the impact of allowing persons
granted an exemption under section 520(m)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with
respect to a device to profit from such device pursuant to
section 520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as
amended by subsection (a)), including--
[[Page H7578]]
(1) an assessment of whether such section 520(m)(6) (as
amended by subsection (a)) has increased the availability of
pediatric devices for conditions that occur in small numbers
of children, including any increase or decrease in the number
of--
(A) exemptions granted under such section 520(m)(2) for
pediatric devices; and
(B) applications approved under section 515 of such Act (21
U.S.C. 360e) for devices intended to treat, diagnose, or cure
conditions that occur in pediatric patients or for devices
labeled for use in a pediatric population;
(2) the conditions or diseases the pediatric devices were
intended to treat or diagnose and the estimated size of the
pediatric patient population for each condition or disease;
(3) the costs of the pediatric devices, based on a survey
of children's hospitals;
(4) the extent to which the costs of such devices are
covered by health insurance;
(5) the impact, if any, of allowing profit on access to
such devices for patients;
(6) the profits made by manufacturers for each device that
receives an exemption;
(7) an estimate of the extent of the use of the pediatric
devices by both adults and pediatric populations for a
condition or disease other than the condition or disease on
the label of such devices;
(8) recommendations of the Comptroller General of the
United States regarding the effectiveness of such section
520(m)(6) (as amended by subsection (a)) and whether any
modifications to such section 520(m)(6) (as amended by
subsection (a)) should be made;
(9) existing obstacles to pediatric device development; and
(10) an evaluation of the demonstration grants described in
section 305.
(c) Guidance.--Not later than 180 days after the date of
enactment of this Act, the Commissioner of Food and Drugs
shall issue guidance for institutional review committees on
how to evaluate requests for approval for devices for which a
humanitarian device exemption under section 520(m)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2))
has been granted.
SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.
(a) Access to Funding.--The Director of the National
Institutes of Health shall designate a contact point or
office at the National Institutes of Health to help
innovators and physicians access funding for pediatric
medical device development.
(b) Plan for Pediatric Medical Device Research.--
(1) In general.--Not later than 180 days after the date of
enactment of this Act, the Commissioner of Food and Drugs, in
collaboration with the Director of the National Institutes of
Health and the Director of the Agency for Healthcare Research
and Quality, 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 plan for expanding pediatric medical device
research and development. In developing such plan, the
Commissioner of Food and Drugs shall consult with individuals
and organizations with appropriate expertise in pediatric
medical devices.
(2) Contents.--The plan under paragraph (1) shall include--
(A) the current status of federally funded pediatric
medical device research;
(B) any gaps in such research, which may include a survey
of pediatric medical providers regarding unmet pediatric
medical device needs, as needed; and
(C) a research agenda for improving pediatric medical
device development and Food and Drug Administration clearance
or approval of pediatric medical devices, and for evaluating
the short- and long-term safety and effectiveness of
pediatric medical devices.
SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE
AVAILABILITY.
(a) In General.--
(1) Request for proposals.--Not later than 90 days after
the date of enactment of this Act, the Secretary of Health
and Human Services shall issue a request for proposals for 1
or more grants or contracts to nonprofit consortia for
demonstration projects to promote pediatric device
development.
(2) Determination on grants or contracts.--Not later than
180 days after the date the Secretary of Health and Human
Services issues a request for proposals under paragraph (1),
the Secretary shall make a determination on the grants or
contracts under this section.
(b) Application.--A nonprofit consortium that desires to
receive a grant or contract under this section shall submit
an application to the Secretary of Health and Human Services
at such time, in such manner, and containing such information
as the Secretary may require.
(c) Use of Funds.--A nonprofit consortium that receives a
grant or contract under this section shall--
(1) encourage innovation by connecting qualified
individuals with pediatric device ideas with potential
manufacturers;
(2) mentor and manage pediatric device projects through the
development process, including product identification,
prototype design, device development, and marketing;
(3) connect innovators and physicians to existing Federal
resources, including resources from the Food and Drug
Administration, the National Institutes of Health, the Small
Business Administration, the Department of Energy, the
Department of Education, the National Science Foundation, the
Department of Veterans Affairs, the Agency for Healthcare
Research and Quality, and the National Institute of Standards
and Technology;
(4) assess the scientific and medical merit of proposed
pediatric device projects;
(5) assess business feasibility and provide business
advice;
(6) provide assistance with prototype development; and
(7) provide assistance with postmarket needs, including
training, logistics, and reporting.
(d) Coordination.--
(1) National institutes of health.--Each consortium that
receives a grant or contract under this section shall--
(A) coordinate with the National Institutes of Health's
pediatric device contact point or office, designated under
section 304; and
(B) provide to the National Institutes of Health any
identified pediatric device needs that the consortium lacks
sufficient capacity to address or those needs in which the
consortium has been unable to stimulate manufacturer
interest.
(2) Food and drug administration.--Each consortium that
receives a grant or contract under this section shall
coordinate with the Commissioner of Food and Drugs and device
companies to facilitate the application for approval or
clearance of devices labeled for pediatric use.
(e) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section $6,000,000 for
each of fiscal years 2008 through 2012.
SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND
PEDIATRIC ADVISORY COMMITTEE.
(a) Office of Pediatric Therapeutics.--Section 6(b) of the
Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is
amended by inserting ``, including increasing pediatric
access to medical devices'' after ``pediatric issues''.
(b) Pediatric Advisory Committee.--Section 14 of the Best
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is
amended--
(1) in subsection (a), by inserting ``(including drugs and
biological products) and medical devices'' after
``therapeutics''; and
(2) in subsection (b)--
(A) in paragraph (1), by inserting ``(including drugs and
biological products) and medical devices'' after
``therapeutics''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking ``and 505B'' and
inserting ``505B, 510(k), 515, and 520(m)'';
(ii) by striking subparagraph (B) and inserting the
following:
``(B) identification of research priorities related to
therapeutics (including drugs and biological products) and
medical devices for pediatric populations and the need for
additional diagnostics and treatments for specific pediatric
diseases or conditions;''; and
(iii) in subparagraph (C), by inserting ``(including drugs
and biological products) and medical devices'' after
``therapeutics''.
SEC. 307. POSTMARKET STUDIES.
Section 522 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360l) is amended--
(1) in subsection (a)--
(A) by inserting ``, or as a condition to approval of an
application (or a supplement to an application) or a product
development protocol under section 515 or as a condition to
clearance of a premarket notification under section 510(k),
for a pediatric population or pediatric subpopulation,''
after ``The Secretary may by order''; and
(B) by inserting ``, or that is indicated for pediatric
populations or subpopulations or is expected to have
significant use in pediatric populations,'' after ``health
consequences''; and
(2) in subsection (b)--
(A) by striking ``(b) Surveillance Approval.--Each'' and
inserting the following:
``(b) Surveillance Approval.--
``(1) In general.--Each'';
(B) by striking ``The Secretary, in consultation'' and
inserting ``Except as provided in paragraph (2), the
Secretary, in consultation'';
(C) by striking ``Any determination'' and inserting
``Except as provided in paragraph (2), any determination'';
and
(D) by adding at the end the following:
``(2) Longer studies for pediatric devices.--The Secretary
may by order require a prospective surveillance period of
more than 36 months with respect to a device that is expected
to have significant use in pediatric populations if such
period of more than 36 months is necessary in order to assess
the impact of the device on growth and development, or the
effects of growth, development, activity level, or other
factors on the safety or efficacy of the device.
``(c) Dispute Resolution.--A manufacturer may request
review under section 562 of any order or condition requiring
postmarket surveillance under this section. During the
pendency of such review, the device subject to such a
postmarket surveillance order or condition shall not be
deemed misbranded under section 502(t) or otherwise in
violation of such order or condition or a related requirement
of this Act unless deemed necessary to protect the public
health.''.
TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007
SEC. 401. SHORT TITLE.
This title may be cited as the ``Pediatric Research Equity
Act of 2007''.
[[Page H7579]]
SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT.
(a) In General.--Section 505B of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355c) is amended to read as
follows:
``SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND
BIOLOGICAL PRODUCTS.
``(a) New Drugs and Biological Products.--
``(1) In general.--A person that submits, on or after the
date of enactment of the Pediatric Research Equity Act of
2007, an application (or supplement to an application)--
``(A) under section 505 for a new active ingredient, new
indication, new dosage form, new dosing regimen, or new route
of administration, or
``(B) under section 351 of the Public Health Service Act
(42 U.S.C. 262) for a new active ingredient, new indication,
new dosage form, new dosing regimen, or new route of
administration,
shall submit with the application the assessments described
in paragraph (2).
``(2) Assessments.--
``(A) In general.--The assessments referred to in paragraph
(1) shall contain data, gathered using appropriate
formulations for each age group for which the assessment is
required, that are adequate--
``(i) to assess the safety and effectiveness of the drug or
the biological product for the claimed indications in all
relevant pediatric subpopulations; and
``(ii) to support dosing and administration for each
pediatric subpopulation for which the drug or the biological
product is safe and effective.
``(B) Similar course of disease or similar effect of drug
or biological product.--
``(i) In general.--If the course of the disease and the
effects of the drug are sufficiently similar in adults and
pediatric patients, the Secretary may conclude that pediatric
effectiveness can be extrapolated from adequate and well-
controlled studies in adults, usually supplemented with other
information obtained in pediatric patients, such as
pharmacokinetic studies.
``(ii) Extrapolation between age groups.--A study may not
be needed in each pediatric age group if data from one age
group can be extrapolated to another age group.
``(iii) Information on extrapolation.--A brief
documentation of the scientific data supporting the
conclusion under clauses (i) and (ii) shall be included in
the medical review that is collected as part of the
application under section 505 of this Act or section 351 of
the Public Health Service Act (42 U.S.C. 262).
``(3) Deferral.--
``(A) In general.--On the initiative of the Secretary or at
the request of the applicant, the Secretary may defer
submission of some or all assessments required under
paragraph (1) until a specified date after approval of the
drug or issuance of the license for a biological product if--
``(i) the Secretary finds that--
``(I) the drug or biological product is ready for approval
for use in adults before pediatric studies are complete;
``(II) pediatric studies should be delayed until additional
safety or effectiveness data have been collected; or
``(III) there is another appropriate reason for deferral;
and
``(ii) the applicant submits to the Secretary--
``(I) certification of the grounds for deferring the
assessments;
``(II) a description of the planned or ongoing studies;
``(III) evidence that the studies are being conducted or
will be conducted with due diligence and at the earliest
possible time; and
``(IV) a timeline for the completion of such studies.
``(B) Annual review.--
``(i) In general.--On an annual basis following the
approval of a deferral under subparagraph (A), the applicant
shall submit to the Secretary the following information:
``(I) Information detailing the progress made in conducting
pediatric studies.
``(II) If no progress has been made in conducting such
studies, evidence and documentation that such studies will be
conducted with due diligence and at the earliest possible
time.
``(ii) Public availability.--The information submitted
through the annual review under clause (i) shall promptly be
made available to the public in an easily accessible manner,
including through the website of the Food and Drug
Administration.
``(4) Waivers.--
``(A) Full waiver.--On the initiative of the Secretary or
at the request of an applicant, the Secretary shall grant a
full waiver, as appropriate, of the requirement to submit
assessments for a drug or biological product under this
subsection if the applicant certifies and the Secretary finds
that--
``(i) necessary studies are impossible or highly
impracticable (because, for example, the number of patients
is so small or the patients are geographically dispersed);
``(ii) there is evidence strongly suggesting that the drug
or biological product would be ineffective or unsafe in all
pediatric age groups; or
``(iii) The drug or biological product--
``(I) does not represent a meaningful therapeutic benefit
over existing therapies for pediatric patients; and
``(II) is not likely to be used in a substantial number of
pediatric patients.
``(B) Partial waiver.--On the initiative of the Secretary
or at the request of an applicant, the Secretary shall grant
a partial waiver, as appropriate, of the requirement to
submit assessments for a drug or biological product under
this subsection with respect to a specific pediatric age
group if the applicant certifies and the Secretary finds
that--
``(i) necessary studies are impossible or highly
impracticable (because, for example, the number of patients
in that age group is so small or patients in that age group
are geographically dispersed);
``(ii) there is evidence strongly suggesting that the drug
or biological product would be ineffective or unsafe in that
age group;
``(iii) the drug or biological product--
``(I) does not represent a meaningful therapeutic benefit
over existing therapies for pediatric patients in that age
group; and
``(II) is not likely to be used by a substantial number of
pediatric patients in that age group; or
``(iv) the applicant can demonstrate that reasonable
attempts to produce a pediatric formulation necessary for
that age group have failed.
``(C) Pediatric formulation not possible.--If a waiver is
granted on the ground that it is not possible to develop a
pediatric formulation, the waiver shall cover only the
pediatric groups requiring that formulation. An applicant
seeking either a full or partial waiver shall submit to the
Secretary documentation detailing why a pediatric formulation
cannot be developed and, if the waiver is granted, the
applicant's submission shall promptly be made available to
the public in an easily accessible manner, including through
posting on the website of the Food and Drug Administration.
``(D) Labeling requirement.--If the Secretary grants a full
or partial waiver because there is evidence that a drug or
biological product would be ineffective or unsafe in
pediatric populations, the information shall be included in
the labeling for the drug or biological product.
``(b) Marketed Drugs and Biological Products.--
``(1) In general.--Beginning on the date of enactment of
the Pediatric Research Equity Act of 2007, after providing
notice in the form of a letter and an opportunity for written
response and a meeting, which may include an advisory
committee meeting, the Secretary may (by order in the form of
a letter) require the sponsor or holder of an approved
application for a drug under section 505 or the holder of a
license for a biological product under section 351 of the
Public Health Service Act to submit by a specified date the
assessments described in subsection (a)(2), if the Secretary
finds that--
``(A)(i) the drug or biological product is used for a
substantial number of pediatric patients for the labeled
indications; and
``(ii) adequate pediatric labeling could confer a benefit
on pediatric patients;
``(B) there is reason to believe that the drug or
biological product would represent a meaningful therapeutic
benefit over existing therapies for pediatric patients for 1
or more of the claimed indications; or
``(C) the absence of adequate pediatric labeling could pose
a risk to pediatric patients.
``(2) Waivers.--
``(A) Full waiver.--At the request of an applicant, the
Secretary shall grant a full waiver, as appropriate, of the
requirement to submit assessments under this subsection if
the applicant certifies and the Secretary finds that--
``(i) necessary studies are impossible or highly
impracticable (because, for example, the number of patients
in that age group is so small or patients in that age group
are geographically dispersed); or
``(ii) there is evidence strongly suggesting that the drug
or biological product would be ineffective or unsafe in all
pediatric age groups.
``(B) Partial waiver.--At the request of an applicant, the
Secretary shall grant a partial waiver, as appropriate, of
the requirement to submit assessments under this subsection
with respect to a specific pediatric age group if the
applicant certifies and the Secretary finds that--
``(i) necessary studies are impossible or highly
impracticable (because, for example, the number of patients
in that age group is so small or patients in that age group
are geographically dispersed);
``(ii) there is evidence strongly suggesting that the drug
or biological product would be ineffective or unsafe in that
age group;
``(iii)(I) the drug or biological product--
``(aa) does not represent a meaningful therapeutic benefit
over existing therapies for pediatric patients in that age
group; and
``(bb) is not likely to be used in a substantial number of
pediatric patients in that age group; and
``(II) the absence of adequate labeling could not pose
significant risks to pediatric patients; or
``(iv) the applicant can demonstrate that reasonable
attempts to produce a pediatric formulation necessary for
that age group have failed.
``(C) Pediatric formulation not possible.--If a waiver is
granted on the ground that it is not possible to develop a
pediatric formulation, the waiver shall cover only the
pediatric groups requiring that formulation. An applicant
seeking either a full or partial waiver shall submit to the
Secretary documentation detailing why a pediatric formulation
cannot be developed and, if the waiver is granted, the
applicant's submission shall
[[Page H7580]]
promptly be made available to the public in an easily
accessible manner, including through posting on the website
of the Food and Drug Administration.
``(D) Labeling requirement.--If the Secretary grants a full
or partial waiver because there is evidence that a drug or
biological product would be ineffective or unsafe in
pediatric populations, the information shall be included in
the labeling for the drug or biological product.
``(c) Meaningful Therapeutic Benefit.--For the purposes of
paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a)
and paragraphs (1)(B)(I) and (2)(B)(iii)(I)(aa) of subsection
(b), a drug or biological product shall be considered to
represent a meaningful therapeutic benefit over existing
therapies if the Secretary determines that--
``(1) if approved, the drug or biological product could
represent an improvement in the treatment, diagnosis, or
prevention of a disease, compared with marketed products
adequately labeled for that use in the relevant pediatric
population; or
``(2) the drug or biological product is in a class of
products or for an indication for which there is a need for
additional options.
``(d) Submission of Assessments.--If a person fails to
submit an assessment described in subsection (a)(2), or a
request for approval of a pediatric formulation described in
subsection (a) or (b), in accordance with applicable
provisions of subsections (a) and (b)--
``(1) the drug or biological product that is the subject of
the assessment or request may be considered misbranded solely
because of that failure and subject to relevant enforcement
action (except that the drug or biological product shall not
be subject to action under section 303); but
``(2) the failure to submit the assessment or request shall
not be the basis for a proceeding--
``(A) to withdraw approval for a drug under section 505(e);
or
``(B) to revoke the license for a biological product under
section 351 of the Public Health Service Act.
``(e) Meetings.--Before and during the investigational
process for a new drug or biological product, the Secretary
shall meet at appropriate times with the sponsor of the new
drug or biological product to discuss--
``(1) information that the sponsor submits on plans and
timelines for pediatric studies; or
``(2) any planned request by the sponsor for waiver or
deferral of pediatric studies.
``(f) Review of Pediatric Plans, Deferrals, and Waivers.--
``(1) Review.--Beginning not later than 30 days after the
date of enactment of the Pediatric Research Equity Act of
2007, the Secretary shall utilize an internal committee to
provide consultation to reviewing divisions on all pediatric
plans and assessments prior to approval of an application or
supplement for which a pediatric assessment is required under
this section and all deferral and waiver requests granted
pursuant to this section. Such internal committee shall
include employees of the Food and Drug Administration, with
expertise in pediatrics (including representation from the
Office of Pediatric Therapeutics), biopharmacology,
statistics, chemistry, legal issues, pediatric ethics, and
the appropriate expertise pertaining to the pediatric product
under review, and other individuals designated by the
Secretary.
``(2) Activity by committee.--The committee referred to in
paragraph (1) may operate using appropriate members of such
committee and need not convene all members of the committee.
``(3) Documentation of committee action.--For each drug or
biological product, the committee referred to in paragraph
(1) shall document, for each activity described in paragraph
(4), which members of the committee participated in such
activity.
``(4) Review of pediatric plans, deferrals and waivers.--
Consultation on pediatric plans and assessments by the
internal committee pursuant to this section shall occur prior
to approval of an application or supplement for which a
pediatric assessment is required under this section. The
internal committee shall review all requests for deferrals
and waivers from the requirement to submit a pediatric
assessment granted under this section and shall provide
recommendations as needed to reviewing divisions.
``(5) Retrospective review of pediatric plans, deferrals
and waivers.--Within one year after enactment of the
Pediatric Research Equity Act of 2007, the committee shall
conduct a retrospective review and analysis of a
representative sample of assessments submitted and deferrals
and waivers approved under this section since enactment of
the Pediatric Research Equity Act of 2003. Such review shall
include an analysis of the quality and consistency of
pediatric information in pediatric assessments and the
appropriateness of waivers and deferrals granted. Based on
such review, the Secretary shall issue recommendations to the
review divisions for improvements and initiate guidance to
industry related to the scope of pediatric studies required
under this section.
``(6) Tracking of assessments and labeling changes.--
Beginning on the date of enactment of the Pediatric Research
Equity Act of 2007, the Secretary shall track and make
available to the public in an easily accessible manner,
including through posting on the website of the Food and Drug
Administration--
``(A) the number of assessments conducted under this
section;
``(B) the specific drugs and biological products and their
uses assessed under this section;
``(C) the types of assessments conducted under this
section, including trial design, the number of pediatric
patients studied, and the number of centers and countries
involved;
``(D) the total number of deferrals requested and granted
under this section and, if granted, the reasons for such
deferrals, the timeline for completion, and the number
completed and pending by the specified date, as outlined in
subsection (a)(3);
``(E) the number of waivers requested and granted under
this section and, if granted, the reasons for the waivers;
``(F) the number of pediatric formulations developed and
the number of pediatric formulations not developed and the
reasons any such formulation was not developed;
``(G) the labeling changes made as a result of assessments
conducted under this section;
``(H) an annual summary of labeling changes made as a
result of assessments conducted under this section for
distribution pursuant to subsection (h)(2); and
``(I) an annual summary of information submitted pursuant
to subsection (a)(3)(B).
``(7) Committee.--The committee utilized under paragraph
(1) shall be the committee established under section
505A(f)(1).
``(g) Labeling Changes.--
``(1) Priority status for pediatric applications.--Any
supplement to an application under section 505 and section
351 of the Public Health Service Act proposing a labeling
change as a result of any pediatric assessments conducted
pursuant to this section--
``(A) shall be considered a priority application or
supplement; and
``(B) shall be subject to the performance goals established
by the Commissioner for priority drugs.
``(2) Dispute resolution.--
``(A) Request for labeling change and failure to agree.--
If, on or after the date of enactment of the Pediatric
Research Equity Act of 2007, the Commissioner determines that
a sponsor and the Commissioner have been unable to reach
agreement on appropriate changes to the labeling for the drug
that is the subject of the application or supplement, not
later than 180 days after the date of the submission of the
application or supplement--
``(i) the Commissioner shall request that the sponsor of
the application make any labeling change that the
Commissioner determines to be appropriate; and
``(ii) if the sponsor does not agree within 30 days after
the Commissioner's request to make a labeling change
requested by the Commissioner, the Commissioner shall refer
the matter to the Pediatric Advisory Committee.
``(B) Action by the pediatric advisory committee.--Not
later than 90 days after receiving a referral under
subparagraph (A)(ii), the Pediatric Advisory Committee
shall--
``(i) review the pediatric study reports; and
``(ii) make a recommendation to the Commissioner concerning
appropriate labeling changes, if any.
``(C) Consideration of recommendations.--The Commissioner
shall consider the recommendations of the Pediatric Advisory
Committee and, if appropriate, not later than 30 days after
receiving the recommendation, make a request to the sponsor
of the application to make any labeling changes that the
Commissioner determines to be appropriate.
``(D) Misbranding.--If the sponsor of the application,
within 30 days after receiving a request under subparagraph
(C), does not agree to make a labeling change requested by
the Commissioner, the Commissioner may deem the drug that is
the subject of the application to be misbranded.
``(E) No effect on authority.--Nothing in this subsection
limits the authority of the United States to bring an
enforcement action under this Act when a drug lacks
appropriate pediatric labeling. Neither course of action (the
Pediatric Advisory Committee process or an enforcement action
referred to in the preceding sentence) shall preclude, delay,
or serve as the basis to stay the other course of action.
``(3) Other labeling changes.--If, on or after the date of
enactment of the Pediatric Research Equity Act of 2007, the
Secretary makes a determination that a pediatric assessment
conducted under this section does or does not demonstrate
that the drug that is the subject of such assessment is safe
and effective in pediatric populations or subpopulations,
including whether such assessment results are inconclusive,
the Secretary shall order the label of such product to
include information about the results of the assessment and a
statement of the Secretary's determination.
``(h) Dissemination of Pediatric Information.--
``(1) In general.--Not later than 180 days after the date
of submission of a pediatric assessment under this section,
the Secretary shall make available to the public in an easily
accessible manner the medical, statistical, and clinical
pharmacology reviews of such pediatric assessments, and shall
post such assessments on the website of the Food and Drug
Administration.
``(2) Dissemination of information regarding labeling
changes.--Beginning on the date of enactment of the Pediatric
Research Equity Act of 2007, the Secretary shall require that
the sponsors of the assessments that result in labeling
changes that
[[Page H7581]]
are reflected in the annual summary developed pursuant to
subsection (f)(6)(H) distribute such information to
physicians and other health care providers.
``(3) Effect of subsection.--Nothing in this subsection
shall alter or amend Section 301(j) of this Act or section
552 of title 5 or section 1905 of title 18, United States
Code.
``(i) Adverse Event Reporting.--
``(1) Reporting in year one.--Beginning on the date of
enactment of the Pediatric Research Equity Act of 2007,
during the one-year period beginning on the date a labeling
change is made pursuant to subsection (g), the Secretary
shall ensure that all adverse event reports that have been
received for such drug (regardless of when such report was
received) are referred to the Office of Pediatric
Therapeutics. In considering the report, the Director of such
Office shall provide for the review of the report by the
Pediatric Advisory Committee, including obtaining any
recommendations of such committee regarding whether the
Secretary should take action under this Act in response to
such report.
``(2) Reporting in subsequent years.--Following the one-
year period described in paragraph (1), the Secretary shall,
as appropriate, refer to the Office of Pediatric Therapeutics
all pediatric adverse event reports for a drug for which a
pediatric study was conducted under this section. In
considering the report, the Director of such Office may
provide for the review of the report by the Pediatric
Advisory Committee, including obtaining any recommendation of
such Committee regarding whether the Secretary should take
action in response to such report.
``(3) Effect.--The requirements of this subsection shall
supplement, not supplant, other review of such adverse event
reports by the Secretary.
``(j) Scope of Authority.--Nothing in this section provides
to the Secretary any authority to require a pediatric
assessment of any drug or biological product, or any
assessment regarding other populations or uses of a drug or
biological product, other than the pediatric assessments
described in this section.
``(k) Orphan Drugs.--Unless the Secretary requires
otherwise by regulation, this section does not apply to any
drug for an indication for which orphan designation has been
granted under section 526.
``(l) Institute of Medicine Study.--
``(1) In general.--Not later than three years after the
date of the enactment of the Pediatric Research Equity Act of
2007, the Secretary shall contract with the Institute of
Medicine to conduct a study and report to Congress regarding
the pediatric studies conducted pursuant to this section
since 1997 and labeling changes made as a result of such
studies.
``(2) Content of study.--The study under paragraph (1)
shall review and assess the use of extrapolation for
pediatric subpopulations, the use of alternative endpoints
for pediatric populations, neonatal assessment tools, the
number and type of pediatric adverse events, and ethical
issues in pediatric clinical trials.
``(3) Representative sample.--The Institute of Medicine may
devise an appropriate mechanism to review a representative
sample of studies conducted pursuant to this section from
each review division within the Center for Drug Evaluation
and Research in order to make the requested assessment.''.
(b) Applicability.--The amendment made in subsection (a)
applies to assessments required under section 505B on or
after the date of enactment of this Act.
SEC. 403. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.
Not later than September 1, 2011, the Comptroller General
of the United States, in consultation with the Secretary of
Health and Human Services, shall submit to the Congress a
report that addresses the effectiveness of sections 505A and
505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a, 355c) and section 409I of the Public Health Service Act
(42 U.S.C. 284m) in ensuring that medicines used by children
are tested and properly labeled. Such report shall include--
(1) the number and importance of drugs and biological
products for children that are being tested as a result of
the amendments made by this title and title V and the
importance for children, health care providers, parents, and
others of labeling changes made as a result of such testing;
(2) the number and importance of drugs and biological
products for children that are not being tested for their use
notwithstanding the provisions of this title and title V and
possible reasons for the lack of testing, including whether
the number of written requests declined by sponsors or
holders of drugs subject to section 505A(g)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a(g)(2)) has
increased or decreased as a result of the amendments made by
this title;
(3) the number of drugs and biological products for which
testing is being done and labeling changes required,
including the date labeling changes are made and which
labeling changes required the use of the dispute resolution
process established pursuant to the amendments made by this
title, together with a description of the outcomes of such
process, including a description of the disputes and the
recommendations of the Pediatric Advisory Committee;
(4) any recommendations for modifications to the programs
established under sections 505A and 505B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I of
the Public Health Service Act (42 U.S.C. 284m) that the
Secretary determines to be appropriate, including a detailed
rationale for each recommendation; and
(5)(A) the efforts made by the Secretary to increase the
number of studies conducted in the neonate population; and
(B) the results of those efforts, including efforts made to
encourage the conduct of appropriate studies in neonates by
companies with products that have sufficient safety and other
information to make the conduct of the studies ethical and
safe.
TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007
SEC. 501. SHORT TITLE.
This title may be cited as the ``Best Pharmaceuticals for
Children Act of 2007''.
SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR
CHILDREN ACT.
(a) Pediatric Studies of Drugs.--
(1) In general.--Section 505A of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a) is amended to read as
follows:
``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
``(a) Definitions.--As used in this section, the term
`pediatric studies' or `studies' means at least one clinical
investigation (that, at the Secretary's discretion, may
include pharmacokinetic studies) in pediatric age groups
(including neonates in appropriate cases) in which a drug is
anticipated to be used, and at the discretion of the
Secretary, may include preclinical studies.
``(b) Market Exclusivity for New Drugs.--
``(1) In general.--Except as provided in paragraph (2), if,
prior to approval of an application that is submitted under
section 505(b)(1), the Secretary determines that information
relating to the use of a new drug in the pediatric population
may produce health benefits in that population, the Secretary
makes a written request for pediatric studies (which shall
include a timeframe for completing such studies), the
applicant agrees to the request, such studies are completed
using appropriate formulations for each age group for which
the study is requested within any such timeframe, and the
reports thereof are submitted and accepted in accordance with
subsection (d)(3), and if the Secretary has determined that
labeling changes are appropriate, such changes are approved
within the timeframe requested by the Secretary--
``(A)(i)(I) the period referred to in subsection
(c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii)
of such section, is deemed to be five years and six months
rather than five years, and the references in subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four
years, to forty-eight months, and to seven and one-half years
are deemed to be four and one-half years, fifty-four months,
and eight years, respectively; or
``(II) the period referred to in clauses (iii) and (iv) of
subsection (c)(3)(E) of such section, and in clauses (iii)
and (iv) of subsection (j)(5)(F) of such section, is deemed
to be three years and six months rather than three years; and
``(ii) if the drug is designated under section 526 for a
rare disease or condition, the period referred to in section
527(a) is deemed to be seven years and six months rather than
seven years; and
``(B)(i) if the drug is the subject of--
``(I) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(ii) or
(j)(2)(A)(vii)(II) of section 505 and for which pediatric
studies were submitted prior to the expiration of the patent
(including any patent extensions); or
``(II) a listed patent for which a certification has been
submitted under subsections (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of section 505,
the period during which an application may not be approved
under section 505(c)(3) or section 505(j)(5)(B) shall be
extended by a period of six months after the date the patent
expires (including any patent extensions); or
``(ii) if the drug is the subject of a listed patent for
which a certification has been submitted under subsection
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in
the patent infringement litigation resulting from the
certification the court determines that the patent is valid
and would be infringed, the period during which an
application may not be approved under section 505(c)(3) or
section 505(j)(5)(B) shall be extended by a period of six
months after the date the patent expires (including any
patent extensions).
``(2) Exception.--The Secretary shall not extend the period
referred to in paragraph (1)(A) or (1)(B) if the
determination is made later than one year prior to the
expiration of such period.
``(c) Market Exclusivity for Already-Marketed Drugs.--
``(1) In general.--Except as provided in paragraph (2), if
the Secretary determines that information relating to the use
of an approved drug in the pediatric population may produce
health benefits in that population and makes a written
request to the holder of an approved application under
section 505(b)(1) for pediatric studies (which shall include
a timeframe for completing such studies), the holder agrees
to the request, such studies are completed using appropriate
formulations for each age group for which the study is
requested within any such
[[Page H7582]]
timeframe and the reports thereof are submitted and accepted
in accordance with subsection (d)(3), and if the Secretary
determines that labeling changes are appropriate and such
changes are approved within the timeframe requested by the
Secretary--
``(A)(i)(I) the period referred to in subsection
(c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii)
of such section, is deemed to be five years and six months
rather than five years, and the references in subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four
years, to forty-eight months, and to seven and one-half years
are deemed to be four and one-half years, fifty-four months,
and eight years, respectively; or
``(II) the period referred to in clauses (iii) and (iv) of
subsection (c)(3)(D) of such section, and in clauses (iii)
and (iv) of subsection (j)(5)(F) of such section, is deemed
to be three years and six months rather than three years; and
``(ii) if the drug is designated under section 526 for a
rare disease or condition, the period referred to in section
527(a) is deemed to be seven years and six months rather than
seven years; and
``(B)(i) if the drug is the subject of--
``(I) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(ii) or
(j)(2)(A)(vii)(II) of section 505 and for which pediatric
studies were submitted prior to the expiration of the patent
(including any patent extensions); or
``(II) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of section 505,
the period during which an application may not be approved
under section 505(c)(3) or section 505(j)(5)(B)(ii) shall be
extended by a period of six months after the date the patent
expires (including any patent extensions); or
``(ii) if the drug is the subject of a listed patent for
which a certification has been submitted under subsection
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in
the patent infringement litigation resulting from the
certification the court determines that the patent is valid
and would be infringed, the period during which an
application may not be approved under section 505(c)(3) or
section 505(j)(5)(B) shall be extended by a period of six
months after the date the patent expires (including any
patent extensions)
``(2) Exception.--The Secretary shall not extend the period
referred to in paragraph (1)(A) or (1)(B) if the
determination is made later than one year prior to the
expiration of such period.
``(d) Conduct of Pediatric Studies.--
``(1) Request for studies.--
``(A) In general.--The Secretary may, after consultation
with the sponsor of an application for an investigational new
drug under section 505(i), the sponsor of an application for
a new drug under section 505(b)(1), or the holder of an
approved application for a drug under section 505(b)(1) issue
to the sponsor or holder a written request for the conduct of
pediatric studies for such drug. In issuing such request, the
Secretary shall take into account adequate representation of
children of ethnic and racial minorities. Such request to
conduct pediatric studies shall be in writing and shall
include a timeframe for such studies and a request to the
sponsor or holder to propose pediatric labeling resulting
from such studies.
``(B) Single written request.--A single written request--
``(i) may relate to more than one use of a drug; and
``(ii) may include uses that are both approved and
unapproved.
``(2) Written request for pediatric studies.--
``(A) Request and response.--
``(i) In general.--If the Secretary makes a written request
for pediatric studies (including neonates, as appropriate)
under subsection (b) or (c), the applicant or holder, not
later than 180 days after receiving the written request,
shall respond to the Secretary as to the intention of the
applicant or holder to act on the request by--
``(I) indicating when the pediatric studies will be
initiated, if the applicant or holder agrees to the request;
or
``(II) indicating that the applicant or holder does not
agree to the request and stating the reasons for declining
the request.
``(ii) Disagree with request.--If, on or after the date of
the enactment of the Best Pharmaceuticals for Children Act of
2007, the applicant or holder does not agree to the request
on the grounds that it is not possible to develop the
appropriate pediatric formulation, the applicant or holder
shall submit to the Secretary the reasons such pediatric
formulation cannot be developed.
``(B) Adverse event reports.--An applicant or holder that,
on or after the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007, agrees to the
request for such studies shall provide the Secretary, at the
same time as the submission of the reports of such studies,
with all postmarket adverse event reports regarding the drug
that is the subject of such studies and are available prior
to submission of such reports.
``(3) Meeting the studies requirement.--Not later than 180
days after the submission of the reports of the studies, the
Secretary shall accept or reject such reports and so notify
the sponsor or holder. The Secretary's only responsibility in
accepting or rejecting the reports shall be to determine,
within the 180-day period, whether the studies fairly respond
to the written request, have been conducted in accordance
with commonly accepted scientific principles and protocols,
and have been reported in accordance with the requirements of
the Secretary for filing.
``(4) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.
``(e) Notice of Determinations on Studies Requirement.--
``(1) In general.--The Secretary shall publish a notice of
any determination, made on or after the date of the enactment
of the Best Pharmaceuticals for Children Act of 2007, that
the requirements of subsection (d) have been met and that
submissions and approvals under subsection (b)(2) or (j) of
section 505 for a drug will be subject to the provisions of
this section. Such notice shall be published not later than
30 days after the date of the Secretary's determination
regarding market exclusivity and shall include a copy of the
written request made under subsection (b) or (c).
``(2) Identification of certain drugs.--The Secretary shall
publish a notice identifying any drug for which, on or after
the date of the enactment of the Best Pharmaceuticals for
Children Act of 2007, a pediatric formulation was developed,
studied, and found to be safe and effective in the pediatric
population (or specified subpopulation) if the pediatric
formulation for such drug is not introduced onto the market
within one year after the date that the Secretary publishes
the notice described in paragraph (1). Such notice
identifying such drug shall be published not later than 30
days after the date of the expiration of such one year
period.
``(f) Internal Review of Written Requests and Pediatric
Studies.--
``(1) Internal review.--
``(A) In general.--The Secretary shall establish an
internal review committee to review all written requests
issued on or after the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007, in accordance with
paragraph (2).
``(B) Members.--The committee established under
subparagraph (A) shall include individuals with expertise in
pediatrics, biopharmacology, statistics, drugs and drug
formulations, legal issues, pediatric ethics, the appropriate
expertise, such as expertise in child and adolescent
psychiatry, pertaining to the pediatric product under review,
one or more experts from the Office of Pediatric
Therapeutics, and other individuals designated by the
Secretary.
``(2) Review of written requests.--The committee
established under paragraph (1) shall review all written
requests issued pursuant to this section prior to being
issued.
``(3) Tracking pediatric studies and labeling changes.--The
Secretary shall track and make available to the public, in an
easily accessible manner, including through posting on the
website of the Food and Drug Administration--
``(A) the number of studies conducted under this section
and under section 409I of the Public Health Service Act;
``(B) the specific drugs and biological products and their
uses, including labeled and off-labeled indications, studied
under such sections;
``(C) the types of studies conducted under such sections,
including trial design, the number of pediatric patients
studied, and the number of centers and countries involved;
``(D) the number of pediatric formulations developed and
the number of pediatric formulations not developed and the
reasons such formulations were not developed;
``(E) the labeling changes made as a result of studies
conducted under such sections;
``(F) an annual summary of labeling changes made as a
result of studies conducted under such sections for
distribution pursuant to subsection (k)(2); and
``(G) information regarding reports submitted on or after
the date of the enactment of the Best Pharmaceuticals for
Children Act of 2007.
``(4) Committee.--The committee established under paragraph
(1) shall be the committee utilized under section 505B(f)(1).
``(g) Limitations.--Notwithstanding subsection (c)(2), a
drug to which the six-month period under subsection (b) or
(c) has already been applied--
``(1) may receive an additional six-month period under
subsection (c)(1)(A)(i)(II) for a supplemental application if
all other requirements under this section are satisfied; and
``(2) may not receive any additional such period under
subsection (c)(1)(A)(ii).
``(h) Relationship to Pediatric Research Requirements.--
Notwithstanding any other provision of law, if any pediatric
study is required by a provision of law (including a
regulation) other than this section and such study meets the
completeness, timeliness, and other requirements of this
section, such study shall be deemed to satisfy the
requirement for market exclusivity pursuant to this section.
``(i) Labeling Changes.--
``(1) Priority status for pediatric applications and
supplements.--Any application or supplement to an application
under section 505 proposing a labeling change as a result of
any pediatric study conducted pursuant to this section--
``(A) shall be considered to be a priority application or
supplement; and
``(B) shall be subject to the performance goals established
by the Commissioner for priority drugs.
``(2) Dispute resolution.--
[[Page H7583]]
``(A) Request for labeling change and failure to agree.--
If, on or after the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007, the Commissioner
determines that the sponsor and the Commissioner have been
unable to reach agreement on appropriate changes to the
labeling for the drug that is the subject of the application,
not later than 180 days after the date of submission of the
application--
``(i) the Commissioner shall request that the sponsor of
the application make any labeling change that the
Commissioner determines to be appropriate; and
``(ii) if the sponsor of the application does not agree
within 30 days after the Commissioner's request to make a
labeling change requested by the Commissioner, the
Commissioner shall refer the matter to the Pediatric Advisory
Committee.
``(B) Action by the pediatric advisory committee.--Not
later than 90 days after receiving a referral under
subparagraph (A)(ii), the Pediatric Advisory Committee
shall--
``(i) review the pediatric study reports; and
``(ii) make a recommendation to the Commissioner concerning
appropriate labeling changes, if any.
``(C) Consideration of recommendations.--The Commissioner
shall consider the recommendations of the Pediatric Advisory
Committee and, if appropriate, not later than 30 days after
receiving the recommendation, make a request to the sponsor
of the application to make any labeling change that the
Commissioner determines to be appropriate.
``(D) Misbranding.--If the sponsor of the application,
within 30 days after receiving a request under subparagraph
(C), does not agree to make a labeling change requested by
the Commissioner, the Commissioner may deem the drug that is
the subject of the application to be misbranded.
``(E) No effect on authority.--Nothing in this subsection
limits the authority of the United States to bring an
enforcement action under this Act when a drug lacks
appropriate pediatric labeling. Neither course of action (the
Pediatric Advisory Committee process or an enforcement action
referred to in the preceding sentence) shall preclude, delay,
or serve as the basis to stay the other course of action.
``(j) Other Labeling Changes.--If, on or after the date of
the enactment of the Best Pharmaceuticals for Children Act of
2007, the Secretary determines that a pediatric study
conducted under this section does or does not demonstrate
that the drug that is the subject of the study is safe and
effective in pediatric populations or subpopulations,
including whether such study results are inconclusive, the
Secretary shall order the labeling of such product to include
information about the results of the study and a statement of
the Secretary's determination.
``(k) Dissemination of Pediatric Information.--
``(1) In general.--Not later than 180 days after the date
of submission of a report on a pediatric study under this
section, the Secretary shall make available to the public the
medical, statistical, and clinical pharmacology reviews of
pediatric studies conducted under subsection (b) or (c).
``(2) Dissemination of information regarding labeling
changes.--Beginning on the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007, the Secretary shall
include as a requirement of a written request that the
sponsors of the studies that result in labeling changes that
are reflected in the annual summary developed pursuant to
subsection (f)(3)(F) distribute, at least annually (or more
frequently if the Secretary determines that it would be
beneficial to the public health), such information to
physicians and other health care providers.
``(3) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.
``(l) Adverse Event Reporting.--
``(1) Reporting in year one.--Beginning on the date of the
enactment of the Best Pharmaceuticals for Children Act of
2007, during the one-year period beginning on the date a
labeling change is approved pursuant to subsection (i), the
Secretary shall ensure that all adverse event reports that
have been received for such drug (regardless of when such
report was received) are referred to the Office of Pediatric
Therapeutics established under section 6 of the Best
Pharmaceuticals for Children Act (Public Law 107-109). In
considering the reports, the Director of such Office shall
provide for the review of the reports by the Pediatric
Advisory Committee, including obtaining any recommendations
of such Committee regarding whether the Secretary should take
action under this Act in response to such reports.
``(2) Reporting in subsequent years.--Following the one-
year period described in paragraph (1), the Secretary shall,
as appropriate, refer to the Office of Pediatric Therapeutics
all pediatric adverse event reports for a drug for which a
pediatric study was conducted under this section. In
considering such reports, the Director of such Office may
provide for the review of such reports by the Pediatric
Advisory Committee, including obtaining any recommendation of
such Committee regarding whether the Secretary should take
action in response to such reports.
``(3) Effect.--The requirements of this subsection shall
supplement, not supplant, other review of such adverse event
reports by the Secretary.
``(m) Clarification of Interaction of Market Exclusivity
Under This Section and Market Exclusivity Awarded to An
Applicant for Approval of A Drug Under Section 505(j).--If a
180-day period under section 505(j)(5)(B)(iv) overlaps with a
6-month exclusivity period under this section, so that the
applicant for approval of a drug under section 505(j)
entitled to the 180-day period under that section loses a
portion of the 180-day period to which the applicant is
entitled for the drug, the 180-day period shall be extended
from--
``(1) the date on which the 180-day period would have
expired by the number of days of the overlap, if the 180-day
period would, but for the application of this subsection,
expire after the 6-month exclusivity period; or
``(2) the date on which the 6-month exclusivity period
expires, by the number of days of the overlap if the 180-day
period would, but for the application of this subsection,
expire during the six-month exclusivity period.
``(n) Referral if Pediatric Studies Not Completed.--
``(1) In general.--Beginning on the date of the enactment
of the Best Pharmaceuticals for Children Act of 2007, if
pediatric studies have not been completed under subsection
(d) and if the Secretary, through the committee established
under subsection (f), determines that there is a continuing
need for information relating to the use of the drug in the
pediatric population (including neonates, as appropriate),
the Secretary shall--
``(A) for a drug for which listed patents have not expired,
make a determination regarding whether an assessment shall be
required to be submitted under section 505B; or
``(B) for a drug that has no listed patents or has 1 or
more listed patents that have expired, determine whether
there are funds available under section 736 to award a grant
to conduct the requested studies pursuant to paragraph (2).
``(2) Funding of studies.--If, pursuant to paragraph (1),
the Secretary determines that there are funds available under
section 736 to award a grant to conduct the requested
pediatric studies, then the Secretary shall issue a proposal
to award a grant to conduct the requested studies. If the
Secretary determines that funds are not available under
section 736, the Secretary shall refer the drug for inclusion
on the list established under section 409I of the Public
Health Service Act or the conduct of studies.
``(3) Public notice.--The Secretary shall give the public
notice of--
``(A) a decision under paragraph (1)(A) not to require an
assessment under section 505B and the basis for such
decision;
``(B) the name of any drug, its manufacturer, and the
indications to be studied pursuant to a grant made under
paragraph (2); and
``(C) any decision under paragraph (2) to include a drug on
the list established under section 409I of the Public Health
Service Act.
``(4) Effect of subsection.--Nothing in this subsection
alters or amends section 301(j) of this Act or section 552 of
title 5 or section 1905 of title 18, United States Code.
``(o) Prompt Approval of Drugs Under Section 505(j) When
Pediatric Information Is Added to Labeling.--
``(1) General rule.--A drug for which an application has
been submitted or approved under section 505(j) shall not be
considered ineligible for approval under that section or
misbranded under section 502 on the basis that the labeling
of the drug omits a pediatric indication or any other aspect
of labeling pertaining to pediatric use when the omitted
indication or other aspect is protected by patent or by
exclusivity under clause (iii) or (iv) of section
505(j)(5)(F).
``(2) Labeling.--Notwithstanding clauses (iii) and (iv) of
section 505(j)(5)(F), the Secretary may require that the
labeling of a drug approved under section 505(j) that omits a
pediatric indication or other aspect of labeling as described
in paragraph (1) include--
``(A) a statement that, because of marketing exclusivity
for a manufacturer--
``(i) the drug is not labeled for pediatric use; or
``(ii) in the case of a drug for which there is an
additional pediatric use not referred to in paragraph (1),
the drug is not labeled for the pediatric use under paragraph
(1); and
``(B) a statement of any appropriate pediatric
contraindications, warnings, or precautions that the
Secretary considers necessary.
``(3) Preservation of pediatric exclusivity and other
provisions.--This subsection does not affect--
``(A) the availability or scope of exclusivity under this
section;
``(B) the availability or scope of exclusivity under
section 505 for pediatric formulations;
``(C) the question of the eligibility for approval of any
application under section 505(j) that omits any other
conditions of approval entitled to exclusivity under clause
(iii) or (iv) of section 505(j)(5)(F); or
``(D) except as expressly provided in paragraphs (1) and
(2), the operation of section 505.
``(p) Institute of Medicine Study.--Not later than 3 years
after the date of the enactment of the Best Pharmaceuticals
for Children Act of 2007, the Secretary shall enter into a
contract with the Institute of Medicine to conduct a study
and report to Congress regarding the written requests made
and the studies conducted pursuant to this section. The
Institute of Medicine may devise an appropriate mechanism to
review a
[[Page H7584]]
representative sample of requests made and studies conducted
pursuant to this section in order to conduct such study. Such
study shall--
``(1) review such representative written requests issued by
the Secretary since 1997 under subsections (b) and (c);
``(2) review and assess such representative pediatric
studies conducted under subsections (b) and (c) since 1997
and labeling changes made as a result of such studies;
``(3) review the use of extrapolation for pediatric
subpopulations, the use of alternative endpoints for
pediatric populations, neonatal assessment tools, and ethical
issues in pediatric clinical trials; and
``(4) make recommendations regarding appropriate incentives
for encouraging pediatric studies of biologics.
``(q) Sunset.--A drug may not receive any 6-month period
under subsection (b) or (c) unless--
``(1) on or before October 1, 2012, the Secretary makes a
written request for pediatric studies of the drug;
``(2) on or before October 1, 2012, an application for the
drug is accepted for filing under section 505(b); and
``(3) all requirements of this section are met.''.
(2) Effective date.--The amendment made by this subsection
shall apply to written requests under section 505A of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) made
after the date of the enactment of this Act.
(b) Program for Pediatric Studies of Drugs.--Section 409I
of the Public Health Service Act (42 U.S.C. 284m) is amended
to read as follows:
``SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.
``(a) List of Priority Issues in Pediatric Therapeutics.--
``(1) In general.--Not later than one year after the date
of the enactment of the Best Pharmaceuticals for Children Act
of 2007, the Secretary, acting through the Director of the
National Institutes of Health and in consultation with the
Commissioner of Food and Drugs and experts in pediatric
research, shall develop and publish a priority list of needs
in pediatric therapeutics, including drugs or indications
that require study. The list shall be revised every three
years.
``(2) Consideration of available information.--In
developing and prioritizing the list under paragraph (1), the
Secretary shall consider--
``(A) therapeutic gaps in pediatrics that may include
developmental pharmacology, pharmacogenetic determinants of
drug response, metabolism of drugs and biologics in children,
and pediatric clinical trials;
``(B) particular pediatric diseases, disorders or
conditions where more complete knowledge and testing of
therapeutics, including drugs and biologics, may be
beneficial in pediatric populations; and
``(C) the adequacy of necessary infrastructure to conduct
pediatric pharmacological research, including research
networks and trained pediatric investigators.
``(b) Pediatric Studies and Research.--The Secretary,
acting through the National Institutes of Health, shall award
funds to entities that have the expertise to conduct
pediatric clinical trials or other research (including
qualified universities, hospitals, laboratories, contract
research organizations, practice groups, federally funded
programs such as pediatric pharmacology research units, other
public or private institutions, or individuals) to enable the
entities to conduct the drug studies or other research on the
issues described in subsection (a). The Secretary may use
contracts, grants, or other appropriate funding mechanisms to
award funds under this subsection.
``(c) Process for Proposed Pediatric Study Requests and
Labeling Changes.--
``(1) Submission of proposed pediatric study request.--The
Director of the National Institutes of Health shall, as
appropriate, submit proposed pediatric study requests for
consideration by the Commissioner of Food and Drugs for
pediatric studies of a specific pediatric indication
identified under subsection (a). Such a proposed pediatric
study request shall be made in a manner equivalent to a
written request made under subsection (b) or (c) of section
505A of the Federal Food, Drug, and Cosmetic Act, including
with respect to the information provided on the pediatric
studies to be conducted pursuant to the request. The Director
of the National Institutes of Health may submit a proposed
pediatric study request for a drug for which--
``(A)(i) there is an approved application under section
505(j) of the Federal Food, Drug, and Cosmetic Act; or
``(ii) there is a submitted application that could be
approved under the criteria of such section; and
``(B) there is no patent protection or market exclusivity
protection for at least one form of the drug under the
Federal Food, Drug, and Cosmetic Act; and
``(C) additional studies are needed to assess the safety
and effectiveness of the use of the drug in the pediatric
population.
``(2) Written request to holders of approved applications
for drugs lacking exclusivity.--The Commissioner of Food and
Drugs, in consultation with the Director of the National
Institutes of Health, may issue a written request based on
the proposed pediatric study request for the indication or
indications submitted pursuant to paragraph (1) (which shall
include a timeframe for negotiations for an agreement) for
pediatric studies concerning a drug identified under
subsection (a) to all holders of an approved application for
the drug under section 505 of the Federal Food, Drug, and
Cosmetic Act. Such a written request shall be made in a
manner equivalent to the manner in which a written request is
made under subsection (b) or (c) of section 505A of such Act,
including with respect to information provided on the
pediatric studies to be conducted pursuant to the request and
using appropriate formulations for each age group for which
the study is requested.
``(3) Requests for proposals.--If the Commissioner of Food
and Drugs does not receive a response to a written request
issued under paragraph (2) not later than 30 days after the
date on which a request was issued, the Secretary, acting
through the Director of the National Institutes of Health and
in consultation with the Commissioner of Food and Drugs,
shall publish a request for proposals to conduct the
pediatric studies described in the written request in
accordance with subsection (b).
``(4) Disqualification.--A holder that receives a first
right of refusal shall not be entitled to respond to a
request for proposals under paragraph (3).
``(5) Contracts, grants, or other funding mechanisms.--A
contract, grant, or other funding may be awarded under this
section only if a proposal is submitted to the Secretary in
such form and manner, and containing such agreements,
assurances, and information as the Secretary determines to be
necessary to carry out this section.
``(6) Reporting of studies.--
``(A) In general.--On completion of a pediatric study in
accordance with an award under this section, a report
concerning the study shall be submitted to the Director of
the National Institutes of Health and the Commissioner of
Food and Drugs. The report shall include all data generated
in connection with the study, including a written request if
issued.
``(B) Availability of reports.--Each report submitted under
subparagraph (A) shall be considered to be in the public
domain (subject to section 505A(d)(4) of the Federal Food,
Drug, and Cosmetic Act) and shall be assigned a docket number
by the Commissioner of Food and Drugs. An interested person
may submit written comments concerning such pediatric studies
to the Commissioner of Food and Drugs, and the written
comments shall become part of the docket file with respect to
each of the drugs.
``(C) Action by commissioner.--The Commissioner of Food and
Drugs shall take appropriate action in response to the
reports submitted under subparagraph (A) in accordance with
paragraph (7).
``(7) Requests for labeling change.--During the 180-day
period after the date on which a report is submitted under
paragraph (6)(A), the Commissioner of Food and Drugs shall--
``(A) review the report and such other data as are
available concerning the safe and effective use in the
pediatric population of the drug studied;
``(B) negotiate with the holders of approved applications
for the drug studied for any labeling changes that the
Commissioner of Food and Drugs determines to be appropriate
and requests the holders to make; and
``(C)(i) place in the public docket file a copy of the
report and of any requested labeling changes; and
``(ii) publish in the Federal Register and through a
posting on the website of the Food and Drug Administration a
summary of the report and a copy of any requested labeling
changes.
``(8) Dispute resolution.--
``(A) Referral to pediatric advisory committee.--If, not
later than the end of the 180-day period specified in
paragraph (7), the holder of an approved application for the
drug involved does not agree to any labeling change requested
by the Commissioner of Food and Drugs under that paragraph,
the Commissioner of Food and Drugs shall refer the request to
the Pediatric Advisory Committee.
``(B) Action by the pediatric advisory committee.--Not
later than 90 days after receiving a referral under
subparagraph (A), the Pediatric Advisory Committee shall--
``(i) review the available information on the safe and
effective use of the drug in the pediatric population,
including study reports submitted under this section; and
``(ii) make a recommendation to the Commissioner of Food
and Drugs as to appropriate labeling changes, if any.
``(9) FDA determination.--Not later than 30 days after
receiving a recommendation from the Pediatric Advisory
Committee under paragraph (8)(B)(ii) with respect to a drug,
the Commissioner of Food and Drugs shall consider the
recommendation and, if appropriate, make a request to the
holders of approved applications for the drug to make any
labeling change that the Commissioner of Food and Drugs
determines to be appropriate.
``(10) Failure to agree.--If a holder of an approved
application for a drug, within 30 days after receiving a
request to make a labeling change under paragraph (9), does
not agree to make a requested labeling change, the
Commissioner of Food and Drugs may deem the drug to be
misbranded under the Federal Food, Drug, and Cosmetic Act.
``(11) No effect on authority.--Nothing in this subsection
limits the authority of the
[[Page H7585]]
United States to bring an enforcement action under the
Federal Food, Drug, and Cosmetic Act when a drug lacks
appropriate pediatric labeling. Neither course of action (the
Pediatric Advisory Committee process or an enforcement action
referred to in the preceding sentence) shall preclude, delay,
or serve as the basis to stay the other course of action.
``(d) Dissemination of Pediatric Information.--Not later
than one year after the date of the enactment of the Best
Pharmaceuticals for Children Act of 2007, the Secretary,
acting through the Director of the National Institutes of
Health, shall study the feasibility of establishing a
compilation of information on pediatric drug use and report
the findings to Congress.
``(e) Authorization of Appropriations.--
``(1) In general.--There are authorized to be appropriated
to carry out this section--
``(A) $200,000,000 for fiscal year 2008; and
``(B) such sums as are necessary for each of the four
succeeding fiscal years.
``(2) Availability.--Any amount appropriated under
paragraph (1) shall remain available to carry out this
section until expended.''.
(c) Fees Relating to Drugs.--Section 735(6) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379(6)) is amended by
adding at the end the following new subparagraph:
``(G) Activities relating to the support of studies of
drugs on pediatric populations under section 505A(n)(1).''.
(d) Foundation for the National Institutes of Health.--
Section 499(c)(1)(C) of the Public Health Service Act (42
U.S.C. 290b(c)(1)(C)) is amended by striking ``and studies
listed by the Secretary pursuant to section 409I(a)(1)(A) of
this Act and referred under section 505A(d)(4)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(a)(d)(4)(C))''.
(e) Continuation of Operation of Committee.--Section 14 of
the Best Pharmaceuticals for Children Act (42 U.S.C. 284m
note) is amended by adding at the end the following new
subsection:
``(d) Continuation of Operation of Committee.--
Notwithstanding section 14 of the Federal Advisory Committee
Act, the advisory committee shall continue to operate during
the five-year period beginning on the date of the enactment
of the Best Pharmaceuticals for Children Act of 2007.''.
(f) Pediatric Subcommittee of the Oncologic Drugs Advisory
Committee.--Section 15 of the Best Pharmaceuticals for
Children Act (42 U.S.C. 284m note) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) in subparagraph (B), by striking ``and'' after the
semicolon;
(ii) in subparagraph (C), by striking the period at the end
and inserting ``; and''; and
(iii) by adding at the end the following new subparagraph:
``(D) provide recommendations to the internal review
committee created under section 505A(f) of the Federal Food,
Drug, and Cosmetic Act regarding the implementation of
amendments to sections 505A and 505B of the Federal Food,
Drug, and Cosmetic Act with respect to the treatment of
pediatric cancers.''; and
(B) by adding at the end the following new paragraph:
``(3) Continuation of operation of subcommittee.--
Notwithstanding section 14 of the Federal Advisory Committee
Act, the Subcommittee shall continue to operate during the
five-year period beginning on the date of the enactment of
the Best Pharmaceuticals for Children Act of 2007.''; and
(2) in subsection (d), by striking ``2003'' and inserting
``2009''.
(g) Effective Date and Limitation for Rule Relating to
Toll-Free Number for Adverse Events on Labeling for Human
Drug Products.--
(1) In general.--Notwithstanding subchapter II of chapter
5, and chapter 7, of title 5, United States Code (commonly
known as the ``Administrative Procedure Act'') and any other
provision of law, the proposed rule issued by the
Commissioner of Food and Drugs entitled ``Toll-Free Number
for Reporting Adverse Events on Labeling for Human Drug
Products,'' 69 Fed. Reg. 21778, (April 22, 2004) shall take
effect on January 1, 2008, unless such Commissioner issues
the final rule before such date.
(2) Limitation.--The proposed rule that takes effect under
subsection (a), or the final rule described under subsection
(a), shall, notwithstanding section 17(a) of the Best
Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not
apply to a drug--
(A) for which an application is approved under section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
(B) that is not described under section 503(b)(1) of such
Act (21 U.S.C. 353(b)(1)); and
(C) the packaging of which includes a toll-free number
through which consumers can report complaints to the
manufacturer or distributor of the drug.
TITLE VI--REAGAN-UDALL FOUNDATION
SEC. 601. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG
ADMINISTRATION.
(a) In General.--Chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at
the end the following:
``Subchapter I--Reagan-Udall Foundation for the Food and Drug
Administration
``SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION.
``(a) In General.--A nonprofit corporation to be known as
the Reagan-Udall Foundation for the Food and Drug
Administration (referred to in this subchapter as the
`Foundation') shall be established in accordance with this
section. The Foundation shall be headed by an Executive
Director, appointed by the members of the Board of Directors
under subsection (e). The Foundation shall not be an agency
or instrumentality of the United States Government.
``(b) Purpose of Foundation.--The purpose of the Foundation
is to advance the mission of the Food and Drug Administration
to modernize medical, veterinary, food, food ingredient, and
cosmetic product development, accelerate innovation, and
enhance product safety.
``(c) Duties of the Foundation.--The Foundation shall--
``(1) taking into consideration the Critical Path reports
and priorities published by the Food and Drug Administration,
identify unmet needs in the development, manufacture, and
evaluation of the safety and effectiveness, including
postapproval, of devices, including diagnostics, biologics,
and drugs, and the safety of food, food ingredients, and
cosmetics, and including the incorporation of more sensitive
and predictive tools and devices to measure safety;
``(2) establish goals and priorities in order to meet the
unmet needs identified in paragraph (1);
``(3) in consultation with the Secretary, identify existing
and proposed Federal intramural and extramural research and
development programs relating to the goals and priorities
established under paragraph (2), coordinate Foundation
activities with such programs, and minimize Foundation
duplication of existing efforts;
``(4) award grants to, or enter into contracts, memoranda
of understanding, or cooperative agreements with, scientists
and entities, which may include the Food and Drug
Administration, university consortia, public-private
partnerships, institutions of higher education, entities
described in section 501(c)(3) of the Internal Revenue Code
(and exempt from tax under section 501(a) of such Code), and
industry, to efficiently and effectively advance the goals
and priorities established under paragraph (2);
``(5) recruit meeting participants and hold or sponsor (in
whole or in part) meetings as appropriate to further the
goals and priorities established under paragraph (2);
``(6) release and publish information and data and, to the
extent practicable, license, distribute, and release
material, reagents, and techniques to maximize, promote, and
coordinate the availability of such material, reagents, and
techniques for use by the Food and Drug Administration,
nonprofit organizations, and academic and industrial
researchers to further the goals and priorities established
under paragraph (2);
``(7) ensure that--
``(A) action is taken as necessary to obtain patents for
inventions developed by the Foundation or with funds from the
Foundation;
``(B) action is taken as necessary to enable the licensing
of inventions developed by the Foundation or with funds from
the Foundation; and
``(C) executed licenses, memoranda of understanding,
material transfer agreements, contracts, and other such
instruments, promote, to the maximum extent practicable, the
broadest conversion to commercial and noncommercial
applications of licensed and patented inventions of the
Foundation to further the goals and priorities established
under paragraph (2);
``(8) provide objective clinical and scientific information
to the Food and Drug Administration and, upon request, to
other Federal agencies to assist in agency determinations of
how to ensure that regulatory policy accommodates scientific
advances and meets the agency's public health mission;
``(9) conduct annual assessments of the unmet needs
identified in paragraph (1); and
``(10) carry out such other activities consistent with the
purposes of the Foundation as the Board determines
appropriate.
``(d) Board of Directors.--
``(1) Establishment.--
``(A) In general.--The Foundation shall have a Board of
Directors (referred to in this subchapter as the `Board'),
which shall be composed of ex officio and appointed members
in accordance with this subsection. All appointed members of
the Board shall be voting members.
``(B) Ex officio members.--The ex officio members of the
Board shall be the following individuals or their designees:
``(i) The Commissioner.
``(ii) The Director of the National Institutes of Health.
``(iii) The Director of the Centers for Disease Control and
Prevention.
``(iv) The Director of the Agency for Healthcare Research
and Quality.
``(C) Appointed members.--
``(i) In general.--The ex officio members of the Board
under subparagraph (B) shall, by majority vote, appoint to
the Board 12 individuals, from a list of candidates to be
provided by the National Academy of Sciences. Of such
appointed members--
``(I) 4 shall be representatives of the general
pharmaceutical, device, food, cosmetic, and biotechnology
industries;
``(II) 3 shall be representatives of academic research
organizations;
``(III) 2 shall be representatives of Government agencies,
including the Food and Drug
[[Page H7586]]
Administration and the National Institutes of Health;
``(IV) 2 shall be representatives of patient or consumer
advocacy organizations; and
``(V) 1 shall be a representative of health care providers.
``(ii) Requirement.--The ex officio members shall ensure
the Board membership includes individuals with expertise in
areas including the sciences of developing, manufacturing,
and evaluating the safety and effectiveness of devices,
including diagnostics, biologics, and drugs, and the safety
of food, food ingredients, and cosmetics.
``(D) Initial meeting.--
``(i) In general.--Not later than 30 days after the date of
the enactment of this Act, the Secretary shall convene a
meeting of the ex officio members of the Board to--
``(I) incorporate the Foundation; and
``(II) appoint the members of the Board in accordance with
subparagraph (C).
``(ii) Service of ex officio members.--Upon the appointment
of the members of the Board under clause (i)(II), the terms
of service of the ex officio members of the Board as members
of the Board shall terminate.
``(iii) Chair.--The ex officio members of the Board under
subparagraph (B) shall designate an appointed member of the
Board to serve as the Chair of the Board.
``(2) Duties of board.--The Board shall--
``(A) establish bylaws for the Foundation that--
``(i) are published in the Federal Register and available
for public comment;
``(ii) establish policies for the selection of the
officers, employees, agents, and contractors of the
Foundation;
``(iii) establish policies, including ethical standards,
for the acceptance, solicitation, and disposition of
donations and grants to the Foundation and for the
disposition of the assets of the Foundation, including
appropriate limits on the ability of donors to designate, by
stipulation or restriction, the use or recipient of donated
funds;
``(iv) establish policies that would subject all employees,
fellows, and trainees of the Foundation to the conflict of
interest standards under section 208 of title 18, United
States Code;
``(v) establish licensing, distribution, and publication
policies that support the widest and least restrictive use by
the public of information and inventions developed by the
Foundation or with Foundation funds to carry out the duties
described in paragraphs (6) and (7) of subsection (c), and
may include charging cost-based fees for published material
produced by the Foundation;
``(vi) specify principles for the review of proposals and
awarding of grants and contracts that include peer review and
that are consistent with those of the Foundation for the
National Institutes of Health, to the extent determined
practicable and appropriate by the Board;
``(vii) specify a cap on administrative expenses for
recipients of a grant, contract, or cooperative agreement
from the Foundation;
``(viii) establish policies for the execution of memoranda
of understanding and cooperative agreements between the
Foundation and other entities, including the Food and Drug
Administration;
``(ix) establish policies for funding training fellowships,
whether at the Foundation, academic or scientific
institutions, or the Food and Drug Administration, for
scientists, doctors, and other professionals who are not
employees of regulated industry, to foster greater
understanding of and expertise in new scientific tools,
diagnostics, manufacturing techniques, and potential barriers
to translating basic research into clinical and regulatory
practice;
``(x) specify a process for annual Board review of the
operations of the Foundation; and
``(xi) establish specific duties of the Executive Director;
``(B) prioritize and provide overall direction to the
activities of the Foundation;
``(C) evaluate the performance of the Executive Director;
and
``(D) carry out any other necessary activities regarding
the functioning of the Foundation.
``(3) Terms and vacancies.--
``(A) Term.--The term of office of each member of the Board
appointed under paragraph (1)(C) shall be 4 years, except
that the terms of offices for the initial appointed members
of the Board shall expire on a staggered basis as determined
by the ex officio members.
``(B) Vacancy.--Any vacancy in the membership of the
Board--
``(i) shall not affect the power of the remaining members
to execute the duties of the Board; and
``(ii) shall be filled by appointment by the appointed
members described in paragraph (1)(C) by majority vote.
``(C) Partial term.--If a member of the Board does not
serve the full term applicable under subparagraph (A), the
individual appointed under subparagraph (B) to fill the
resulting vacancy shall be appointed for the remainder of the
term of the predecessor of the individual.
``(D) Serving past term.--A member of the Board may
continue to serve after the expiration of the term of the
member until a successor is appointed.
``(4) Compensation.--Members of the Board may not receive
compensation for service on the Board. Such members may be
reimbursed for travel, subsistence, and other necessary
expenses incurred in carrying out the duties of the Board, as
set forth in the bylaws issued by the Board.
``(e) Incorporation.--The ex officio members of the Board
shall serve as incorporators and shall take whatever actions
necessary to incorporate the Foundation.
``(f) Nonprofit Status.--The Foundation shall be considered
to be a corporation under section 501(c) of the Internal
Revenue Code of 1986, and shall be subject to the provisions
of such section.
``(g) Executive Director.--
``(1) In general.--The Board shall appoint an Executive
Director who shall serve at the pleasure of the Board. The
Executive Director shall be responsible for the day-to-day
operations of the Foundation and shall have such specific
duties and responsibilities as the Board shall prescribe.
``(2) Compensation.--The compensation of the Executive
Director shall be fixed by the Board but shall not be greater
than the compensation of the Commissioner.
``(h) Administrative Powers.--In carrying out this
subchapter, the Board, acting through the Executive Director,
may--
``(1) adopt, alter, and use a corporate seal, which shall
be judicially noticed;
``(2) hire, promote, compensate, and discharge 1 or more
officers, employees, and agents, as may be necessary, and
define their duties;
``(3) prescribe the manner in which--
``(A) real or personal property of the Foundation is
acquired, held, and transferred;
``(B) general operations of the Foundation are to be
conducted; and
``(C) the privileges granted to the Board by law are
exercised and enjoyed;
``(4) with the consent of the applicable executive
department or independent agency, use the information,
services, and facilities of such department or agencies in
carrying out this section;
``(5) enter into contracts with public and private
organizations for the writing, editing, printing, and
publishing of books and other material;
``(6) hold, administer, invest, and spend any gift, devise,
or bequest of real or personal property made to the
Foundation under subsection (i);
``(7) enter into such other contracts, leases, cooperative
agreements, and other transactions as the Board considers
appropriate to conduct the activities of the Foundation;
``(8) modify or consent to the modification of any contract
or agreement to which it is a party or in which it has an
interest under this subchapter;
``(9) take such action as may be necessary to obtain
patents and licenses for devices and procedures developed by
the Foundation and its employees;
``(10) sue and be sued in its corporate name, and complain
and defend in courts of competent jurisdiction;
``(11) appoint other groups of advisors as may be
determined necessary to carry out the functions of the
Foundation; and
``(12) exercise other powers as set forth in this section,
and such other incidental powers as are necessary to carry
out its powers, duties, and functions in accordance with this
subchapter.
``(i) Acceptance of Funds From Other Sources.--The
Executive Director may solicit and accept on behalf of the
Foundation, any funds, gifts, grants, devises, or bequests of
real or personal property made to the Foundation, including
from private entities, for the purposes of carrying out the
duties of the Foundation.
``(j) Service of Federal Employees.--Federal Government
employees may serve on committees advisory to the Foundation
and otherwise cooperate with and assist the Foundation in
carrying out its functions, so long as such employees do not
direct or control Foundation activities.
``(k) Detail of Government Employees; Fellowships.--
``(1) Detail from federal agencies.--Federal Government
employees may be detailed from Federal agencies with or
without reimbursement to those agencies to the Foundation at
any time, and such detail shall be without interruption or
loss of civil service status or privilege. Each such employee
shall abide by the statutory, regulatory, ethical, and
procedural standards applicable to the employees of the
agency from which such employee is detailed and those of the
Foundation.
``(2) Voluntary service; acceptance of federal employees.--
``(A) Foundation.--The Executive Director of the Foundation
may accept the services of employees detailed from Federal
agencies with or without reimbursement to those agencies.
``(B) Food and drug administration.--The Commissioner may
accept the uncompensated services of Foundation fellows or
trainees. Such services shall be considered to be undertaking
an activity under contract with the Secretary as described in
section 708.
``(l) Annual Reports.--
``(1) Reports to foundation.--Any recipient of a grant,
contract, fellowship, memorandum of understanding, or
cooperative agreement from the Foundation under this section
shall submit to the Foundation a report on an annual basis
for the duration of such grant, contract, fellowship,
memorandum of understanding, or cooperative agreement, that
describes the activities carried out under such grant,
contract, fellowship, memorandum of understanding, or
cooperative agreement.
[[Page H7587]]
``(2) Report to congress and the fda.--Beginning with
fiscal year 2009, the Executive Director shall submit to
Congress and the Commissioner an annual report that--
``(A) describes the activities of the Foundation and the
progress of the Foundation in furthering the goals and
priorities established under subsection (c)(2), including the
practical impact of the Foundation on regulated product
development;
``(B) provides a specific accounting of the source and use
of all funds used by the Foundation to carry out such
activities; and
``(C) provides information on how the results of Foundation
activities could be incorporated into the regulatory and
product review activities of the Food and Drug
Administration.
``(m) Separation of Funds.--The Executive Director shall
ensure that the funds received from the Treasury are held in
separate accounts from funds received from entities under
subsection (i).
``(n) Funding.--From amounts appropriated to the Food and
Drug Administration for each fiscal year, the Commissioner
shall transfer not less than $500,000 and not more than
$1,250,000, to the Foundation to carry out subsections (a),
(b), and (d) through (m).''.
(b) Other Foundation Provisions.--Chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.)
(as amended by subsection (a)) is amended by adding at the
end the following:
``SEC. 771. LOCATION OF FOUNDATION.
``The Foundation shall, if practicable, be located not more
than 20 miles from the District of Columbia.
``SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.
``(a) In General.--The Commissioner shall receive and
assess the report submitted to the Commissioner by the
Executive Director of the Foundation under section 770(l)(2).
``(b) Report to Congress.--Beginning with fiscal year 2009,
the Commissioner shall submit to Congress an annual report
summarizing the incorporation of the information provided by
the Foundation in the report described under section
770(l)(2) and by other recipients of grants, contracts,
memoranda of understanding, or cooperative agreements into
regulatory and product review activities of the Food and Drug
Administration.
``(c) Extramural Grants.--The provisions of this subchapter
shall have no effect on any grant, contract, memorandum of
understanding, or cooperative agreement between the Food and
Drug Administration and any other entity entered into before,
on, or after the date of enactment of this subchapter.''.
(c) Conforming Amendment.--Section 742(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379l(b)) is amended
by adding at the end the following: ``Any such fellowships
and training programs under this section or under section
770(d)(2)(A)(ix) may include provision by such scientists and
physicians of services on a voluntary and uncompensated
basis, as the Secretary determines appropriate. Such
scientists and physicians shall be subject to all legal and
ethical requirements otherwise applicable to officers or
employees of the Department of Health and Human Services.''.
SEC. 602. OFFICE OF THE CHIEF SCIENTIST.
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 391 et seq.) is amended by adding at the end the
following:
``SEC. 910. OFFICE OF THE CHIEF SCIENTIST.
``(a) Establishment; Appointment.--The Secretary shall
establish within the Office of the Commissioner an office to
be known as the Office of the Chief Scientist. The Secretary
shall appoint a Chief Scientist to lead such Office.
``(b) Duties of the Office.--The Office of the Chief
Scientist shall--
``(1) oversee, coordinate, and ensure quality and
regulatory focus of the intramural research programs of the
Food and Drug Administration;
``(2) track and, to the extent necessary, coordinate
intramural research awards made by each center of the
Administration or science-based office within the Office of
the Commissioner, and ensure that there is no duplication of
research efforts supported by the Reagan-Udall Foundation for
the Food and Drug Administration;
``(3) develop and advocate for a budget to support
intramural research;
``(4) develop a peer review process by which intramural
research can be evaluated; and
``(5) identify and solicit intramural research proposals
from across the Food and Drug Administration through an
advisory board composed of employees of the Administration
that shall include--
``(A) representatives of each of the centers and the
science-based offices within the Office of the Commissioner;
and
``(B) experts on trial design, epidemiology, demographics,
pharmacovigilance, basic science, and public health.''.
SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding
at the end the following:
``SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
``(a) Establishment.--The Secretary, acting through the
Commissioner of Food and Drugs, shall enter into
collaborative agreements, to be known as Critical Path
Public-Private Partnerships, with one or more eligible
entities to implement the Critical Path Initiative of the
Food and Drug Administration by developing innovative,
collaborative projects in research, education, and outreach
for the purpose of fostering medical product innovation,
enabling the acceleration of medical product development, and
enhancing medical product safety.
``(b) Eligible Entity.--In this section, the term `eligible
entity' means an entity that meets each of the following:
``(1) The entity is--
``(A) an institution of higher education (as such term is
defined in section 101 of the Higher Education Act of 1965);
or
``(B) an organization described in section 501(c)(3) of the
Internal Revenue Code of 1986 and exempt from tax under
section 501(a) of such Code.
``(2) The entity has experienced personnel and clinical and
other technical expertise in the biomedical sciences.
``(3) The entity demonstrates to the Secretary's
satisfaction that the entity is capable of--
``(A) developing and critically evaluating tools, methods,
and processes--
``(i) to increase efficiency, predictability, and
productivity of medical product development; and
``(ii) to more accurately identify the benefits and risks
of new and existing medical products;
``(B) establishing partnerships, consortia, and
collaborations with health care practitioners and other
providers of health care goods or services; pharmacists;
pharmacy benefit managers and purchasers; health maintenance
organizations and other managed health care organizations;
health care insurers; government agencies; patients and
consumers; manufacturers of prescription drugs, biological
products, diagnostic technologies, and devices; and academic
scientists; and
``(C) securing funding for the projects of a Critical Path
Public-Private Partnership from Federal and nonfederal
governmental sources, foundations, and private individuals.
``(c) Funding.--The Secretary may not enter into a
collaborative agreement under subsection (a) unless the
eligible entity involved provides an assurance that the
entity will not accept funding for a Critical Path Public-
Private Partnership project from any organization that
manufactures or distributes products regulated by the Food
and Drug Administration unless--
``(1) the entity accepts such funding for such project from
2 or more such organizations; and
``(2) the entity provides assurances in its agreement with
the Food and Drug Administration that the results of the
Critical Path Public-Private Partnership project will not be
influenced by any source of funding.
``(d) Annual Report.--Not later than 18 months after the
date of the enactment of this section, and annually
thereafter, the Secretary, in collaboration with the parties
to each Critical Path Public-Private Partnership, shall
submit a report to the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives--
``(1) reviewing the operations and activities of the
Partnerships in the previous year; and
``(2) addressing such other issues relating to this section
as the Secretary determines to be appropriate.
``(e) Definition.--In this section, the term `medical
product' includes a drug, a biological product, a device, and
any combination of such products.
``(f) Authorization of Appropriations.--To carry out this
section, there are authorized to be appropriated $5,000,000
for fiscal year 2008 and such sums as may be necessary for
each of fiscal years 2009 through 2012.''.
TITLE VII--CONFLICTS OF INTEREST
SEC. 701. CONFLICTS OF INTEREST.
(a) In General.--Subchapter A of chapter VII of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is
amended by inserting at the end the following:
``SEC. 712. CONFLICTS OF INTEREST.
``(a) Definitions.--For purposes of this section:
``(1) Advisory committee.--The term `advisory committee'
means an advisory committee under the Federal Advisory
Committee Act that provides advice or recommendations to the
Secretary regarding activities of the Food and Drug
Administration.
``(2) Financial interest.--The term `financial interest'
means a financial interest under section 208(a) of title 18,
United States Code.
``(b) Appointments to Advisory Committees.--
``(1) Recruitment.--
``(A) In general.--Given the importance of advisory
committees to the review process at the Food and Drug
Administration, the Secretary, through the Office of Women's
Health, the Office of Orphan Product Development, the Office
of Pediatric Therapeutics, and other offices within the Food
and Drug Administration with relevant expertise, shall
develop and implement strategies on effective outreach to
potential members of advisory committees at universities,
colleges, other academic research centers, professional and
medical societies, and patient and consumer groups. The
Secretary shall
[[Page H7588]]
seek input from professional medical and scientific societies
to determine the most effective informational and recruitment
activities. The Secretary shall also take into account the
advisory committees with the greatest number of vacancies.
``(B) Recruitment activities.--The recruitment activities
under subparagraph (A) may include--
``(i) advertising the process for becoming an advisory
committee member at medical and scientific society
conferences;
``(ii) making widely available, including by using existing
electronic communications channels, the contact information
for the Food and Drug Administration point of contact
regarding advisory committee nominations; and
``(iii) developing a method through which an entity
receiving funding from the National Institutes of Health, the
Agency for Healthcare Research and Quality, the Centers for
Disease Control and Prevention, or the Veterans Health
Administration can identify a person who the Food and Drug
Administration can contact regarding the nomination of
individuals to serve on advisory committees.
``(2) Evaluation and criteria.--When considering a term
appointment to an advisory committee, the Secretary shall
review the expertise of the individual and the financial
disclosure report filed by the individual pursuant to the
Ethics in Government Act of 1978 for each individual under
consideration for the appointment, so as to reduce the
likelihood that an appointed individual will later require a
written determination as referred to in section 208(b)(1) of
title 18, United States Code, a written certification as
referred to in section 208(b)(3) of title 18, United States
Code, or a waiver as referred to in subsection (c)(3) of this
section for service on the committee at a meeting of the
committee.
``(3) Participation of guest expert with financial
interest.--Notwithstanding any other provision of this
section, an individual with a financial interest with respect
to any matter considered by an advisory committee may be
allowed to participate in a meeting of an advisory committee
as a guest expert if the Secretary determines that the
individual has particular expertise required for the meeting.
An individual participating as a guest expert may provide
information and expert opinion, but shall not participate in
the discussion or voting by the members of the advisory
committee.
``(c) Granting and Disclosure of Waivers.--
``(1) In general.--Prior to a meeting of an advisory
committee regarding a `particular matter' (as that term is
used in section 208 of title 18, United States Code), each
member of the committee who is a full-time Government
employee or special Government employee shall disclose to the
Secretary financial interests in accordance with subsection
(b) of such section 208.
``(2) Financial interest of advisory committee member or
family member.--No member of an advisory committee may vote
with respect to any matter considered by the advisory
committee if such member (or an immediate family member of
such member) has a financial interest that could be affected
by the advice given to the Secretary with respect to such
matter, excluding interests exempted in regulations issued by
the Director of the Office of Government Ethics as too remote
or inconsequential to affect the integrity of the services of
the Government officers or employees to which such
regulations apply.
``(3) Waiver.--The Secretary may grant a waiver of the
prohibition in paragraph (2) if such waiver is necessary to
afford the advisory committee essential expertise.
``(4) Limitations.--
``(A) One waiver per committee meeting.--Notwithstanding
any other provision of this section, with respect to each
advisory committee, the Secretary shall not grant more than 1
waiver under paragraph (3) per committee meeting.
``(B) Scientific work.--The Secretary may not grant a
waiver under paragraph (3) for a member of an advisory
committee when the member's own scientific work is involved.
``(5) Disclosure of waiver.--Notwithstanding section
107(a)(2) of the Ethics in Government Act (5 U.S.C. App.),
the following shall apply:
``(A) 15 or more days in advance.--As soon as practicable,
but in no case later than 15 days prior to a meeting of an
advisory committee to which a written determination as
referred to in section 208(b)(1) of title 18, United States
Code, a written certification as referred to in section
208(b)(3) of title 18, United States Code, or a waiver as
referred to in paragraph (3) applies, the Secretary shall
disclose (other than information exempted from disclosure
under section 552 of title 5, United States Code, and section
552a of title 5, United States Code (popularly known as the
Freedom of Information Act and the Privacy Act of 1974,
respectively)) on the Internet website of the Food and Drug
Administration--
``(i) the type, nature, and magnitude of the financial
interests of the advisory committee member to which such
determination, certification, or waiver applies; and
``(ii) the reasons of the Secretary for such determination,
certification, or waiver.
``(B) Less than 30 days in advance.--In the case of a
financial interest that becomes known to the Secretary less
than 30 days prior to a meeting of an advisory committee to
which a written determination as referred to in section
208(b)(1) of title 18, United States Code, a written
certification as referred to in section 208(b)(3) of title
18, United States Code, or a waiver as referred to in
paragraph (3) applies, the Secretary shall disclose (other
than information exempted from disclosure under section 552
of title 5, United States Code, and section 552a of title 5,
United States Code) on the Internet website of the Food and
Drug Administration, the information described in clauses (i)
and (ii) of subparagraph (A) as soon as practicable after the
Secretary makes such determination, certification, or waiver,
but in no case later than the date of such meeting.
``(d) Public Record.--The Secretary shall ensure that the
public record and transcript of each meeting of an advisory
committee includes the disclosure required under subsection
(c)(5) (other than information exempted from disclosure under
section 552 of title 5, United States Code, and section 552a
of title 5, United States Code).
``(e) Annual Report.--Not later than February 1 of each
year, the Secretary shall submit to the Committee on
Appropriations and the Committee on Health, Education, Labor,
and Pensions of the Senate, and the Committee on
Appropriations and the Committee on Energy and Commerce of
the House of Representatives a report that describes--
``(1) with respect to the fiscal year that ended on
September 30 of the previous year, the number of vacancies on
each advisory committee, the number of nominees received for
each committee, and the number of such nominees willing to
serve;
``(2) with respect to such year, the aggregate number of
disclosures required under subsection (c)(5) for each meeting
of each advisory committee and the percentage of individuals
to whom such disclosures did not apply who served on such
committee for each such meeting;
``(3) with respect to such year, the number of times the
disclosures required under subsection (c)(5) occurred under
subparagraph (B) of such subsection; and
``(4) how the Secretary plans to reduce the number of
vacancies reported under paragraph (1) during the fiscal year
following such year, and mechanisms to encourage the
nomination of individuals for service on an advisory
committee, including those who are classified by the Food and
Drug Administration as academicians or practitioners.
``(f) Periodic Review of Guidance.--Not less than once
every 5 years, the Secretary shall review guidance of the
Food and Drug Administration regarding conflict of interest
waiver determinations with respect to advisory committees and
update such guidance as necessary.''.
(b) Conforming Amendment.--Section 505(n) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended--
(1) by striking paragraph (4); and
(2) by redesignating paragraphs (5), (6), (7), and (8) as
paragraphs (4), (5), (6), and (7), respectively.
(c) Effective Date.--The amendments made by this section
shall take effect on October 1, 2007.
TITLE VIII--CLINICAL TRIAL DATABASES
SEC. 801. CLINICAL TRIAL REGISTRY DATABASE AND CLINICAL TRIAL
RESULTS DATABASE.
(a) In General.--Title IV of the Public Health Service Act
(42 U.S.C. 281 et seq.) is amended--
(1) in section 402, by striking subsection (i); and
(2) by inserting after section 492B the following new
section:
``SEC. 492C. CLINICAL TRIAL REGISTRY DATABASE; CLINICAL TRIAL
RESULTS DATABASE.
``(a) Definitions.--In this section:
``(1) Applicable clinical trial.--The term `applicable
clinical trial'--
``(A) means a clinical trial that is conducted to test the
safety or effectiveness (including comparative effectiveness)
of a drug or device (irrespective of whether the clinical
trial is federally or privately funded, and whether the
clinical trial involves an approved or unapproved drug or
device);
``(B) includes such a clinical trial that is conducted
outside of the United States if--
``(i) there is an application or premarket notification
pending before the Food and Drug Administration for approval
or clearance of the drug or device involved under section
505, 510(k), or 515 of the Federal Food, Drug, and Cosmetic
Act or section 351 of this Act; or
``(ii) the drug or device involved is so approved or
cleared; and
``(C) notwithstanding subparagraphs (A) and (B), excludes--
``(i) a clinical trial to determine the safety of a use of
a drug that is designed solely to detect major toxicities in
the drug or to investigate pharmacokinetics, unless the
clinical trial is designed to investigate pharmacokinetics in
a special population or populations; and
``(ii) a small clinical trial to determine the feasibility
of a device, or a clinical trial to test prototype devices
where the primary focus is feasibility.
``(2) Clinical trial information.--The term `clinical trial
information' means those data elements that are necessary to
complete an entry in the clinical trial registry database
under subsection (b) or the clinical trial results database
under subsection (c), as applicable.
[[Page H7589]]
``(3) Completion date.--The term `completion date' means
the date of the final collection of data from subjects in the
clinical trial for the primary and secondary outcomes to be
examined in the trial.
``(4) Device.--The term `device' has the meaning given to
that term in section 201(h) of the Federal Food, Drug, and
Cosmetic Act.
``(5) Drug.--The term `drug' means a drug as defined in
section 201(g) of the Federal Food, Drug, and Cosmetic Act or
a biological product as defined in section 351 of this Act.
``(6) Responsible party.--The term `responsible party',
with respect to an applicable clinical trial, means--
``(A) the primary sponsor (as defined in the International
Clinical Trials Registry Platform trial registration data set
of the World Health Organization) of the clinical trial; or
``(B) the principal investigator of such clinical trial if
so designated by such sponsor, so long as the principal
investigator is responsible for conducting the trial, has
access to and control over the data, has the right to publish
the results of the trial, and has the responsibility to meet
all of the requirements under this section that are
applicable to responsible parties.
``(b) Clinical Trials Registry Database.--
``(1) Establishment.--To enhance patient enrollment and
provide a mechanism to track subsequent progress of clinical
trials, the Secretary, acting through the Director of NIH,
shall establish and administer a clinical trial registry
database in accordance with this section (referred to in this
section as the `registry database'). The Director of NIH
shall ensure that the registry database is made publicly
available through the Internet.
``(2) Content.--The Secretary shall promulgate regulations
for the submission to the registry database of clinical trial
information that--
``(A) conforms to the International Clinical Trials
Registry Platform trial registration data set of the World
Health Organization;
``(B) includes the city, State, and zip code for each
clinical trial location or a toll free number through which
such location information may be accessed;
``(C) includes a statement of the estimated completion date
for the clinical trial;
``(D) includes the identity and contact information of the
responsible party;
``(E) if the drug is not approved under section 505 of the
Federal Food, Drug, and Cosmetic Act or licensed under
section 351 of this Act, or the device is not cleared under
section 510(k) or approved under section 515 of the Federal
Food, Drug, and Cosmetic Act, specifies whether or not there
is expanded access to the drug or device under section 561 of
the Federal Food, Drug, and Cosmetic Act for those who do not
qualify for enrollment in the clinical trial and how to
obtain information about such access;
``(F) includes, with respect to any individual who is not
an employee of the responsible party for the clinical trial
or of the manufacturer of the drug or device involved,
information on whether the responsible party or manufacturer
has entered into any agreement with such individual that
restricts in any manner the ability of the individual--
``(i) to discuss the results of the trial at a scientific
meeting or any other public or private forum; or
``(ii) to publish the results of the trial, or a
description or discussion of the results of the trial, in a
scientific or academic journal; and
``(G) requires the inclusion of such other data elements to
the registry database as appropriate.
``(3) Format and structure.--
``(A) Searchable categories.--The Director of NIH shall
ensure that the public may search the entries in the registry
database by 1 or more of the following criteria:
``(i) The indication being studied in the clinical trial,
using Medical Subject Headers (MeSH) descriptors.
``(ii) The safety issue being studied in the clinical
trial.
``(iii) The enrollment status of the clinical trial.
``(iv) The sponsor of the clinical trial.
``(B) Format.--The Director of the NIH shall ensure that
the registry database is easily used by patients, and that
entries are easily compared.
``(4) Data submission.--The responsible party for an
applicable clinical trial shall submit to the Director of NIH
for inclusion in the registry database the clinical trial
information described in paragraph (2).
``(5) Truthful clinical trial information.--
``(A) In general.--The clinical trial information submitted
by a responsible party under this subsection shall not be
false or misleading.
``(B) Effect.--Subparagraph (A) shall not have the effect
of requiring clinical trial information to include
information from any source other than the clinical trial
involved.
``(6) Timing of submission.--Except as provided in
paragraph (7), the clinical trial information for a clinical
trial required to be submitted under this subsection shall be
submitted not later than 14 days after the first patient is
enrolled in such clinical trial.
``(7) Updates.--The responsible party for an applicable
clinical trial shall submit to the Director of NIH for
inclusion in the registry database periodic updates to
reflect changes to the clinical trial information submitted
under this subsection. Such updates--
``(A) shall be provided not less than once every 6 months
until information on the results of the trial is submitted
under subsection (c);
``(B) shall include identification of the dates of any such
changes;
``(C) not later than 30 days after the enrollment status of
such clinical trial changes, shall include an update of the
enrollment status; and
``(D) not later than 30 days after the completion date of
the clinical trial, shall include a report to the Director
that such clinical trial is complete.
``(8) Applicability of device trials.--In the case of an
applicable clinical trial regarding a device, the responsible
person for the trial shall submit to the Director of NIH the
clinical trial information as required in paragraph (4), but
the Director may not make the information publicly available
through the registry database until the device is approved or
cleared (as the case may be).
``(c) Clinical Trials Results Database.--
``(1) Establishment.--To ensure that results of clinical
trials are made public and that patients and providers have
current information regarding the results of clinical trials,
the Secretary, acting through the Director of NIH, shall
establish and administer a clinical trial results database in
accordance with this section (referred to in this section as
the `results database'). The Director of NIH shall ensure
that the results database is made publicly available through
the Internet.
``(2) Searchable categories.--The Director of NIH shall
ensure that the public may search the entries in the results
database by 1 or more of the following:
``(A) The indication studied in the clinical trial, using
Medical Subject Headers (MeSH) descriptors.
``(B) The safety issue studied in the clinical trial.
``(C) Whether an application for the tested indication is
approved, pending approval, withdrawn, or not submitted.
``(D) The phase of the clinical trial.
``(E) The name of the drug or device that is the subject of
the clinical trial.
``(F) Within the documents described in clauses (i) and
(ii) of paragraph (3)(B), the following information, as
applicable:
``(i) The sponsor of the clinical trial.
``(ii) Each financial sponsor of the clinical trial.
``(3) Contents.--
``(A) In general.--The responsible party for an applicable
clinical trial shall submit to the Director of NIH for
inclusion in the results database the clinical trial
information described in subparagraph (B).
``(B) Required elements.--In submitting clinical trial
information for a clinical trial to the Director of NIH for
inclusion in the results database, the responsible party
shall include, with respect to such clinical trial, the
following information:
``(i) The information described in subparagraphs (A)
through (E) of subsection (b)(2).
``(ii) A summary that is written in non-technical,
understandable language for patients that includes the
following:
``(I) The purpose of the clinical trial.
``(II) The sponsor of the clinical trial.
``(III) A point of contact for information about the
clinical trial.
``(IV) A description of the patient population tested in
the clinical trial.
``(V) A general description of the clinical trial and
results, including a description of and the reasons for any
changes in the clinical trial design that occurred since the
date of submission of clinical trial information for
inclusion in the registry database established under
subsection (b) and a description of any significant safety
information.
``(iii) A summary that is technical in nature that includes
the following:
``(I) The purpose of the clinical trial.
``(II) The sponsor of the clinical trial.
``(III) Each financial sponsor of the clinical trial.
``(IV) A point of contact for scientific information about
the clinical trial.
``(V) A description of the patient population tested in the
clinical trial.
``(VI) A general description of the clinical trial and
results, including a description of and the reasons for any
changes in the clinical trial design that occurred since the
date of submission of clinical trial information for the
clinical trial in the registry database established under
subsection (b).
``(VII) Summary data describing the results, including--
``(aa) whether the primary endpoint was achieved, including
relevant statistics;
``(bb) an assessment of any secondary endpoints, if
applicable, including relevant statistics; and
``(cc) any significant safety information, including a
summary of the incidence of serious adverse events observed
in the clinical trial and a summary of the most common
adverse events observed in the clinical trial and the
frequencies of such events.
``(iv) With respect to the group of subjects receiving the
drug or device involved, and each comparison group of
subjects, the percentage of individuals who ceased
participation as subjects and the reasons for ceasing
participation.
``(v) With respect to an individual who is not an employee
of the responsible party for the clinical trial or of the
manufacturer of the drug or device involved, information (to
the extent not submitted under subsection (b)(2)(F)) on any
agreement that the responsible party or manufacturer has
entered into
[[Page H7590]]
with such individual that restricts in any manner the ability
of the individual--
``(I) to discuss the results of the trial at a scientific
meeting or any other public or private forum; or
``(II) to publish the results of the trial, or a
description or discussion of the results of the trial, in a
scientific or academic journal.
``(vi) The completion date of the clinical trial.
``(vii) A link to the Internet web posting of any adverse
regulatory actions taken by the Food and Drug Administration,
such as a warning letter, that was substantively based on the
clinical trial design, outcome, or representation made by the
applicant about the design or outcome of the clinical trial.
``(C) Links in database.--The Director of NIH shall ensure
that the results database includes the following:
``(i) Links to Medline citations to publications reporting
results from each applicable drug clinical trial and
applicable device clinical trial.
``(ii) Links to the entry for the product that is the
subject of an applicable drug clinical trial in the National
Library of Medicine database of structured product labels, if
available.
``(iii) Links described in clauses (i) and (ii) for data
bank entries for clinical trials submitted to the data bank
prior to enactment of this section, as available.
``(4) Timing.--
``(A) In general.--Except as provided in subparagraphs (B)
and (C), a responsible party shall submit to the Director of
NIH for inclusion in the results database clinical trial
information for an applicable clinical trial not later than 1
year after the earlier of--
``(i) the estimated completion date of the trial, as
submitted under subsection (b)(2); or
``(ii) the actual date of the completion, or termination
before completion, of the trial, as applicable.
``(B) Extensions.--The Director of NIH may provide an
extension of the deadline for submission of clinical trial
information under subparagraph (A) if the responsible party
for the trial submits to the Director a written request that
demonstrates good cause for the extension and provides an
estimate of the date on which the information will be
submitted. The Director of NIH may grant more than one such
extension for the clinical trial involved.
``(C) Updates.--The responsible party for an applicable
clinical trial shall submit to the Director of NIH for
inclusion in the results database periodic updates to reflect
changes in the clinical trial information submitted under
this subsection. Such updates--
``(i) shall be provided not less frequently than once every
6 months during the 10-year period beginning on the date on
which information is due under subparagraph (A);
``(ii) shall identify the dates on which the changes were
made; and
``(iii) shall include, not later than 30 days after any
change in the regulatory status of the drug or device
involved, an update informing the Director of NIH of such
change.
``(5) Truthful clinical trial information.--
``(A) In general.--The clinical trial information submitted
by a responsible party under this subsection shall not be
false or misleading in any particular.
``(B) Effect.--Subparagraph (A) shall not have the effect
of requiring clinical trial information with respect to a
clinical trial to include information from any source other
than such clinical trial.
``(6) Public availability of results.--
``(A) Pre-approval studies.--Except as provided in
subparagraph (E), with respect to an applicable clinical
trial that is completed before the drug is initially approved
under section 505 of the Federal Food, Drug, and Cosmetic Act
or initially licensed under section 351 of this Act, or the
device is initially cleared under section 510(k) or approved
under section 515 of the Federal Food, Drug, and Cosmetic
Act, the Director of NIH shall make publicly available on the
results database the clinical trial information submitted for
such clinical trial not later than 30 days after--
``(i) the drug or device is approved under such section
505, licensed under such section 351, cleared under such
section 510(k), or approved under such section 515, as
applicable; or
``(ii) the Secretary issues a not approvable letter or a
not substantially equivalent letter for the drug or device
under such section 505, 351, 510(k), or 515, as applicable.
``(B) Medical and clinical pharmacology reviews of pre-
approval studies.--Not later than 90 days after the date
applicable under clause (i) or (ii) of subparagraph (A) with
respect to an applicable clinical trial, the Director of NIH
shall make publicly available on the results database a
summary of the available medical and clinical pharmacology
reviews conducted by the Food and Drug Administration for
such trial.
``(C) Post-approval studies.--Except as provided in
subparagraphs (D) and (E), with respect to an applicable
clinical trial that is completed after the drug is initially
approved under such section 505 or licensed under such
section 351, or the device is initially cleared under such
section 510(k) or approved under such section 515, the
Director of NIH shall make publicly available on the results
database the clinical trial information submitted for such
clinical trial not later than 30 days after the date of such
submission.
``(D) Seeking approval of a new use for the drug or
device.--
``(i) In general.--If the manufacturer of the drug or
device is the sponsor or a financial sponsor of an applicable
clinical trial, and such manufacturer certifies to the
Director of NIH that such manufacturer has filed, or will
file within 1 year, an application seeking approval under
such section 505, licensing under such section 351, clearance
under such section 510(k), or approval under such section 515
for the use studied in such clinical trial (which use is not
included in the labeling of the approved drug or device),
then the Director of NIH shall make publicly available on the
results database the clinical trial information submitted for
such clinical trial on the earlier of the date that is 30
days after the date--
``(I) the new use of the drug or device is approved under
such section 505, licensed under such section 351, cleared
under such section 510(k), or approved under such section
515;
``(II) the Secretary issues a not approvable letter or a
not substantially equivalent letter for the new use of the
drug or device under such section 505, 351, 510(k), or 515;
or
``(III) the application or premarket notification under
such section 505, 351, 510(k), or 515 is withdrawn.
``(ii) Limitation on certification.--If a manufacturer
makes a certification under clause (i) with respect to a
clinical trial, the manufacturer shall make such a
certification with respect to each applicable clinical trial
that is required to be submitted in an application for
approval of the use studied in the clinical trial.
``(iii) 2-year limitation.--The clinical trial information
subject to clause (i) shall be made publicly available on the
results database on the date that is 2 years after the date
the certification referred to in clause (i) was made to the
Director of NIH, if a regulatory action referred to in
subclause (I), (II), or (III) of clause (i) has not occurred
by such date.
``(iv) Medical and clinical pharmacology reviews.--Not
later than 90 days after the date applicable under subclause
(I), (II), or (III) of clause (i) or clause (iii) with
respect to an applicable clinical trial, the Director of NIH
shall make publicly available on the results database a
summary of the available medical and clinical pharmacology
reviews conducted by the Food and Drug Administration for
such trial.
``(E) Seeking publication.--
``(i) In general.--If the principal investigator of an
applicable clinical trial is seeking publication in a peer-
reviewed biomedical journal of a manuscript based on the
results of the clinical trial and the responsible party so
certifies to the Director of NIH--
``(I) the responsible party shall notify the Director of
NIH of the publication date of such manuscript not later than
15 days after such date; and
``(II) the Director of NIH shall make publicly available on
the results database the clinical trial information submitted
for such clinical trial on the date that is 30 days after the
publication date of such manuscript.
``(ii) Limitations.--The clinical trial information subject
to clause (i)--
``(I) shall be made publicly available on the results
database on the date that is 2 years after the date that the
clinical trial information was required to be submitted to
the Director of NIH if the manuscript referred to in such
clause has not been published by such date; and
``(II) shall not be required to be made publicly available
under section 552 of title 5, United States Code (commonly
known as the `Freedom of Information Act'), prior to the date
applicable to such clinical trial information under this
subparagraph.
``(7) Verification of submission prior to public
availability.--In the case of clinical trial information that
is submitted under this subsection, but is not made publicly
available pending either regulatory action or publication
under subparagraph (D) or (E) of paragraph (6), as
applicable, the Director of NIH shall respond to inquiries
from other Federal agencies and peer-reviewed journals to
confirm that such clinical trial information has been
submitted but has not yet been made publicly available on the
results database.
``(d) Updates; Tracking of Changes in Submitted
Information.--The Director of NIH shall ensure that updates
submitted to the Director under subsections (b)(7) and (c)(4)
do not result in the removal from the registry database or
the results database of the original submissions or of any
preceding updates, and that information in such databases is
presented in a manner that enables users to readily access
each original submission and to track the changes made by the
updates.
``(e) Coordination and Compliance.--
``(1) Consultation with other federal agencies.--The
Secretary shall--
``(A) consult with other agencies that conduct human
studies in accordance with part 46 of title 45, Code of
Federal Regulations (or any successor regulations), to
determine if any such studies are applicable clinical trials;
and
``(B) develop with such agencies appropriate procedures to
ensure that clinical trial information for such applicable
clinical trials is submitted under subsection (b) and (c).
``(2) Coordination of registry database and results
database.--
[[Page H7591]]
``(A) In general.--Each entry in the registry database
under subsection (b) or the results database under subsection
(c) shall include a link to the corresponding entry in the
results database or the registry database, respectively.
``(B) Missing entries.--
``(i) In general.--If, based on a review of the entries in
the registry database under subsection (b), the Director of
NIH determines that a responsible party has failed to submit
required clinical trial information to the results database
under subsection (c), the Director of NIH shall inform the
responsible party involved of such failure and permit the
responsible party to correct the failure within 30 days.
``(ii) Failure to correct.--If the responsible party does
not correct a failure to submit required clinical trial
information within the 30-day period described under clause
(i), the Director of NIH shall report such noncompliance to
the scientific peer review committees of the Federal research
agencies and to the Office of Human Research Protections.
``(iii) Public notice of failure to correct.--The Director
of NIH shall include in the clinical trial registry database
entry and the clinical trial results database entry for each
applicable clinical trial a notice of any uncorrected failure
to submit required clinical trial information and shall
provide that the public may easily search for such entries.
``(3) Action on applications.--
``(A) Verification prior to filing.--The Secretary, acting
through the Commissioner of Food and Drugs, shall verify that
the clinical trial information required under subsections (b)
and (c) for an applicable clinical trial is submitted
pursuant to such subsections, as applicable--
``(i) when considering a drug or device for an exemption
under section 505(i) or section 520(g) of the Federal Food,
Drug, and Cosmetic Act; and
``(ii) prior to filing an application or premarket
notification under section 505, 510(k), or 515 of the Federal
Food, Drug, and Cosmetic Act or section 351 of this Act, that
includes information from such clinical trial.
``(B) Notification.--If the Secretary determines under
subparagraph (A) that clinical trial information has not been
submitted as required by subsection (b) or (c), the Secretary
shall notify the applicant and the responsible party of such
noncompliance and require submission of such information
within 30 days.
``(C) Refusal to file.--If the responsible party does not
remedy such noncompliance within 30 days of receipt of
notification under subparagraph (B), the Secretary shall
refuse to file, approve, or clear such application or
premarket notification.
``(4) Content review.--
``(A) In general.--To ensure that the summary documents
described in subsection (c)(3) are non-promotional, and are
not false or misleading in any particular under subsection
(c)(5), the Secretary shall compare such documents to the
results data of the clinical trial for a representative
sample of applicable clinical trials by--
``(i) acting through the Commissioner of Food and Drugs to
examine the results data for such clinical trials submitted
to Secretary when such data are submitted--
``(I) for review as part of an application under section
505 or 515 of the Federal Food, Drug, and Cosmetic Act or
under section 351 of this Act or a premarket notification
under section 510(k) of the Federal Food, Drug, and Cosmetic
Act; or
``(II) in an annual status report on the drug or device
under such application;
``(ii) acting with the Federal agency that funds such
clinical trial in whole or in part by a grant to examine the
results data for such clinical trials; and
``(iii) acting through inspections under section 704 of the
Federal Food, Drug, and Cosmetic Act to examine results data
for such clinical trials not described in clause (i) or (ii).
``(B) Notice of noncompliance.--If the Secretary determines
that the clinical trial information submitted in such a
summary document is false or misleading in any particular,
the Secretary shall notify the responsible party and give
such party an opportunity to remedy such noncompliance by
submitting the required revised clinical trial information
within 30 days of such notification.
``(f) Penalties for Noncompliance.--
``(1) In general.--The following acts and the causing
thereof are unlawful:
``(A) The failure to submit clinical trial information as
required by this section.
``(B) The submission of clinical trial information under
this section that is false or misleading in any particular in
violation of subsection (b)(5) or (c)(5).
``(2) Certain penalties.--Section 303(a) of the Federal
Food, Drug, and Cosmetic Act applies with respect to a
violation of paragraph (1) to the same extent and in the same
manner as such section 303(a) applies with respect to a
violation of section 301 of such Act.
``(3) Considerations.--In determining whether to apply a
penalty under paragraph (2) or under paragraph (4) for a
violation described in paragraph (1), the Secretary, acting
through the Commissioner of Food and Drugs, shall consider--
``(A) whether the responsible party promptly corrects the
noncompliance when provided notice;
``(B) whether the responsible party has engaged in a
pattern or practice of noncompliance; and
``(C) the extent to which the noncompliance involved may
have significantly misled health care providers or patients
concerning the safety or effectiveness of the drug involved.
``(4) Civil penalties.--
``(A) In general.--A person is subject to a civil penalty
in accordance with this paragraph if the person commits a
violation described in paragraph (1) and fails to correct the
violation by the end of the 30-day period described in
subparagraph (B).
``(B) Notification.--If a person is in violation of
paragraph (1), the Secretary shall notify the person of such
noncompliance and give the person a 30-day period to correct
such violation before imposing a civil penalty under this
paragraph.
``(C) Amount of penalty.--The amount of a civil penalty
under this subsection shall be not more than a total of
$15,000 for all violations adjudicated in a single proceeding
in the case of an individual, and not more than $10,000 per
day until the violation is corrected in the case of any other
person, except that if the person is a nonprofit entity the
penalty may not exceed a total of $15,000 for all violations
adjudicated in a single proceeding.
``(D) Procedures.--The provisions of paragraphs (4) through
(6) of section 303(f) of the Federal Food, Drug, and Cosmetic
Act apply to the imposition of a penalty under this
subsection to the same extent and in the same manner as such
provisions apply to a penalty imposed under such section
303(f).
``(g) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section
$10,000,000 for each fiscal year.''.
(b) Conforming Amendments.--
(1) Investigational new drugs.--Section 505(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is
amended--
(A) in paragraph (1)--
(i) in subparagraph (C), by striking ``and'' after the
semicolon;
(ii) in subparagraph (D)--
(I) by aligning the indentation of such subparagraph with
the indentation of subparagraphs (A), (B), and (C); and
(II) by striking the period at the end and inserting ``;
and''; and
(iii) by adding at the end the following:
``(E) the submission to the Director of NIH of clinical
trial information for the clinical investigation at issue
required under section 492C of the Public Health Service Act
for inclusion in the registry database and the results
database described in such section.'';
(B) in paragraph (3)(B)--
(i) in clause (i), by striking ``or'' after the semicolon;
(ii) in clause (ii), by striking the period at the end and
inserting ``; or''; and
(iii) by adding at the end the following:
``(iii) clinical trial information for the clinical
investigation at issue was not submitted in compliance with
section 492C of the Public Health Service Act.''; and
(C) in paragraph (4), by adding at the end the following:
``The Secretary shall update such regulations to require
inclusion in the informed consent form a statement that
clinical trial information for such clinical investigation
will be submitted for inclusion in the registry database and
results database, as applicable, described in section 492C of
the Public Health Service Act.''.
(2) Refusal to approve new drug application.--Section
505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(d)) is amended--
(A) in the first sentence, by inserting after ``in any
particular;'' the following: ``or (8) the applicant failed to
submit the clinical trial information for any applicable
clinical trial as required by section 492C of the Public
Health Service Act;''; and
(B) in the second sentence, by striking ``clauses (1)
through (6)'' and inserting ``paragraphs (1) through (8)''.
(3) Investigational new devices.--Subparagraph (B) of
section 520(g)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j(g)(2)) is amended--
(A) by redesignating clause (iii) as clause (iv); and
(B) by inserting after clause (ii) the following:
``(iii) A requirement that the person applying for an
exemption for a device assure that such person is in
compliance with the requirements of section 492C of the
Public Health Service Act for the submission of clinical
trial information for inclusion in the registry database and
the results database described in such section.''.
(4) Refusal to clear new device premarket notification
report.--Subsection (k) of section 510 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360) is amended--
(A) in paragraph (1), by striking ``and'' at the end; and
(B) in paragraph (2), by striking the period at the end and
inserting ``, and''; and
(C) by adding at the end the following:
``(3) action taken by such person to comply with
requirements under section 492C of the Public Health Service
Act for the submission of clinical trial information for
inclusion in the registry database and the results database
described in such section.''.
(5) Refusal to approve new device application.--Paragraph
(2) of section 515(d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e(d)) is amended--
[[Page H7592]]
(A) in subparagraph (D), by striking ``or'' at the end;
(B) in subparagraph (E), by striking the period at the end
and inserting ``; or''; and
(C) by inserting after subparagraph (E) the following:
``(F) the applicant is in violation of the requirements
under section 492C of the Public Health Service Act for the
submission of clinical trial information for inclusion in the
registry database or the results database described in such
section.''.
(c) Guidance.--Not later than 180 days after the date of
the enactment of this Act, the Commissioner of Food and
Drugs, in consultation with the Director of the National
Institutes of Health, shall issue guidance to clarify which
clinical trials are applicable clinical trials (as defined in
section 492C of the Public Health Service Act, as amended by
this section) and required to be submitted for inclusion in
the clinical trial registry database described in such
section.
(d) Preemption.--
(1) In general.--No State or political subdivision of a
State may establish or continue in effect any requirement for
the registration of clinical trials or any requirement for
the inclusion of information relating to the results of
clinical trials in a database.
(2) Rule of construction.--The fact of submission of
clinical trial information, if submitted in compliance with
section 492C of the Public Health Service Act (as amended by
this section), that relates to a use of a drug or device not
included in the official labeling of the approved drug or
device shall not be construed by the Secretary or in any
administrative or judicial proceeding, as evidence of a new
intended use of the drug or device that is different from the
intended use of the drug or device set forth in the official
labeling of the drug or device. The availability of clinical
trial information through the databases under subsections (b)
and (c) of such section 492C, if submitted in compliance with
such section 492C, shall not be considered as labeling,
adulteration, or misbranding of the drug or device under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(e) Effective Dates.--
(1) Establishment of registry database and results
database.--Not later than 1 year after the date of the
enactment of this Act, the Director of NIH shall establish
the registry database and the results database of clinical
trials of drugs and devices in accordance with section 492C
of the Public Health Service Act (as amended by subsection
(a)).
(2) Clinical trials initiated prior to operation of
registry database.--The responsible party (as defined in such
section 492C) for an applicable clinical trial (as defined in
such section 492C) that is initiated after the date of the
enactment of this Act and before the date such registry
database is established under paragraph (1) of this
subsection, shall submit required clinical trial information
not later than 120 days after the date such registry database
is established.
(3) Clinical trials initiated after operation of registry
database.--The responsible party (as defined in such section
492C) for an applicable clinical trial (as defined in such
section 492C) that is initiated after the date such registry
database is established under paragraph (1) of this
subsection shall submit required clinical trial information
in accordance with subsection (b) of such section 492C.
(4) Trials completed before operation of results
database.--
(A) In general.--Subsection (c) of such section 492C shall
take effect 90 days after the date the results database is
established under paragraph (1) of this subsection with
respect to any applicable clinical trial (as defined in such
section 492C) that--
(i) involves a drug to treat a serious or life-threatening
condition; and
(ii) is completed between the date of the enactment of this
Act and such date of establishment under paragraph (1) of
this subsection.
(B) Other trials.--Except as provided in subparagraph (A),
subsection (c) of such section 492C shall take effect 180
days after the date that the results database is established
under paragraph (1) of this subsection with respect to any
applicable clinical trial that is completed between the date
of the enactment of this Act and such date of establishment
under paragraph (1).
(5) Trials completed after establishment of results
database.--Subsection (c) of such section 492C shall apply to
any clinical trial that is completed after the date that the
results database is established under paragraph (1) of this
subsection.
(6) Retroactivity of database.--
(A) Voluntary submissions.--The Secretary of Health and
Human Services (referred to in this paragraph as the
``Secretary'') shall establish procedures and mechanisms to
allow for the voluntary submission to the Secretary--
(i) of clinical trial information for inclusion in the
registry database (as defined in such section 492C) on
applicable clinical trials (as defined in such section 492C)
initiated before the date of the enactment of this Act; and
(ii) of clinical trial information for inclusion in the
results database (as defined in such section 492C) on
applicable clinical trials (as defined in such section 492C)
completed before the date of the enactment of this Act.
(B) Required submissions.--Notwithstanding the preceding
paragraphs of this subsection, in any case in which the
Secretary determines that submission of clinical trial
information for an applicable clinical trial (as defined in
such section 492C) described in clause (i) or (ii) of
subparagraph (A) is in the interest of the public health--
(i) the Secretary may require that such information be
submitted to the Secretary in accordance with such section
492C; and
(ii) failure to comply with such a requirement shall be
treated as a violation of the corresponding requirement of
such section 492C.
(7) Status of clinicaltrials.gov website.--
(A) In general.--After receiving public comment and not
later than 90 days after the date of the enactment of this
Act, the Secretary shall publish in the Federal Register a
notice determining the more efficient approach to
establishing the registry database described in subsection
(b) of such section 492C and whether such approach is--
(i) that such registry database should expand and build
upon the data bank described in section 402(i) of the Public
Health Service Act (as in effect on the day before the date
of the enactment of this Act); or
(ii) that such registry database should supplant the data
bank described in such section 402(i) (as in effect on the
day before the date of the enactment of this Act).
(B) Clinicaltrials.gov supplanted.--If the Secretary
determines to apply the approach described under subparagraph
(A)(ii), the Secretary shall maintain an archive of the data
bank described in such section 402(i) (as in effect on the
day before the date of the enactment of this Act) on the
Internet website of the National Library of Medicine.
SEC. 802. STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE.
(a) In General.--The Comptroller General of the United
States shall conduct a study to determine whether information
on the trials registry and database is considered promotional
and to evaluate the implementation of this database.
(b) Report.--Not later than one year after the date of the
enactment of this Act, the Comptroller General shall complete
the study under subsection (a) and submit to the Congress a
report on the results of such study.
TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS
SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS REGARDING
HUMAN DRUGS; RISK EVALUATION AND MITIGATION
STRATEGIES.
(a) In General.--Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) is amended by adding at the end
the following subsections:
``(o) Postmarket Studies and Clinical Trials; Labeling.--
``(1) In general.--A responsible person may not introduce
or deliver for introduction into interstate commerce the new
drug involved if the person is in violation of a requirement
established under paragraph (3) or (4) with respect to the
drug.
``(2) Definitions.--For purposes of this subsection:
``(A) Responsible person.--The term `responsible person'
means a person who--
``(i) has submitted to the Secretary a covered application
that is pending; or
``(ii) is the holder of an approved covered application.
``(B) Covered application.--The term `covered application'
means--
``(i) an application under subsection (b) for a drug that
is subject to section 503(b); and
``(ii) an application under section 351 of the Public
Health Service Act.
``(C) New safety information; serious risk.--The terms `new
safety information', `serious risk', and `signal of a serious
risk' have the meanings given such terms in section 505-1(b).
``(3) Studies and clinical trials.--
``(A) In general.--For any or all of the purposes specified
in subparagraph (B), the Secretary may, subject to
subparagraph (C), require a responsible person for a drug to
conduct a postapproval study or studies of the drug, or a
postapproval clinical trial or trials of the drug, on the
basis of scientific information, including information
regarding chemically-related or pharmacologically-related
drugs.
``(B) Purposes of study or trial.--The purposes referred to
in this subparagraph with respect to a postapproval study or
postapproval clinical trial are the following:
``(i) To assess a known serious risk related to the use of
the drug involved.
``(ii) To assess signals of serious risk related to the use
of the drug.
``(iii) To identify a serious risk.
``(C) Establishment of requirement after approval of
covered application.--The Secretary may require a
postapproval study or studies or postapproval trial or trials
for a drug for which an approved covered application is in
effect as of the date on which the Secretary seeks to
establish such requirement only if the Secretary becomes
aware of new safety information. For each study required to
be conducted under this subparagraph, the Secretary shall
require that the applicant submit a timetable for completion
of the study and shall require the applicant to periodically
report to the Secretary on the status of the study. Unless
the applicant demonstrates good cause for failure to comply
with such timeline, the applicant shall be in violation of
this subsection.
[[Page H7593]]
The Secretary shall determine what constitutes good cause
under the preceding sentence.
``(4) Safety labeling changes requested by secretary.--
``(A) New safety information.--The Secretary shall promptly
notify the responsible person if the Secretary becomes aware
of new safety information that the Secretary believes should
be included in the labeling of the drug.
``(B) Response to notification.--Following notification
pursuant to subparagraph (A), the responsible person shall
within 30 days--
``(i) submit a supplement proposing changes to the approved
labeling to reflect the new safety information, including
changes to boxed warnings, contraindications, warnings,
precautions, or adverse reactions; or
``(ii) notify the Secretary that the responsible person
does not believe a labeling change is warranted and submit a
statement detailing the reasons why such a change is not
warranted.
``(C) Review.--Upon receipt of such supplement, the
Secretary shall promptly review and act upon such supplement.
If the Secretary disagrees with the proposed changes in the
supplement or with the statement setting forth the
responsible person's reasons why no labeling change is
necessary, the Secretary shall initiate discussions with the
responsible person to reach agreement on whether the labeling
for the drug should be modified to reflect the new safety
information, and if so, the contents of such labeling
changes.
``(D) Discussions.--Such discussions shall not extend for
more than 30 days after the response to the notification
under subparagraph (B), unless the Secretary determines an
extension of such discussion period is warranted.
``(E) Order.--Within 15 days of the conclusion of the
discussions under subparagraph (D), the Secretary may issue
an order directing the responsible person to make such a
labeling change as the Secretary deems appropriate to address
the new safety information. Within 15 days of such an order,
the responsible person shall submit a supplement containing
the labeling change.
``(F) Dispute resolution.--Within 5 days of receiving an
order under subparagraph (E), the responsible person may
appeal using the Food and Drug Administration's normal
dispute resolution procedures established by the Secretary in
regulation and guidance.
``(G) Violation.--If the change required by an order under
subparagraph (E) is not made by the date so specified, the
responsible person shall be considered to be in violation of
this section.
``(H) Serious public health threat.--Notwithstanding
subparagraphs (A) through (F), if the Secretary concludes
that failure to make such a labeling change is necessary to
protect against a serious public health threat, the Secretary
may accelerate the timelines in such subparagraphs.
``(I) Rule of construction.--This paragraph shall not be
construed to affect the responsibility of the responsible
person to maintain its label in accordance with existing
requirements, including subpart B and section 314.70 of title
21, Code of Federal Regulations (or any successor
regulations).
``(p) Risk Evaluation and Mitigation Strategy.--
``(1) In general.--A person may not introduce or deliver
for introduction into interstate commerce a new drug if--
``(A)(i) the application for such drug is approved under
subsection (b) or (j) and is subject to section 503(b); or
``(ii) the application for such drug is approved under
section 351 of the Public Health Service Act; and
``(B) a risk evaluation and mitigation strategy is required
under section 505-1 with respect to the drug and--
``(i) the person fails to maintain compliance with the
requirements of the approved strategy or with other
requirements under section 505-1, including requirements
regarding assessments of approved strategies; or
``(ii) in the case of a requirement for such a strategy
that is first established after the applicable application
referred to in subparagraph (A) was approved with respect to
the drug, the Secretary, after notice and opportunity for a
hearing, publishes in the Federal Register a statement that
the person is not cooperating with the Secretary in
developing such a strategy for the drug.
``(2) Required statement during approval process.--In the
case of an application approved under subsection (b) or (j)
for a new drug that is subject to section 503(b), or an
application approved under section 351 of the Public Health
Service Act, or a supplement to such an application that
requires substantive data, the Secretary may not approve the
application or supplement unless the person involved has
complied with the following:
``(A) The person has submitted to the Secretary a statement
that provides the following information:
``(i) Whether the person believes that a risk evaluation
and mitigation strategy should be required under section 505-
1.
``(ii) Whether a postmarket study or clinical trial should
be required under subsection (o)(3).
``(B) In making the statement under subparagraph (A), the
person took into account each of the following factors:
``(i) The estimated size of the population likely to use
the drug involved.
``(ii) The seriousness of the disease or condition that is
to be treated with the drug.
``(iii) The expected benefit of the drug with respect to
such disease or condition.
``(iv) The expected or actual duration of treatment with
the drug.
``(v) The seriousness of any known or potential adverse
events that may be related to the drug and the background
incidence of such events in the population likely to use the
drug.
``(3) Certain postmarket studies.--The failure to conduct a
postmarket study under subpart H of part 314 of title 21,
Code of Federal Regulations (or any successor regulation), is
deemed to be a violation of paragraph (1).''.
(b) Requirements Regarding Strategies.--Chapter V of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.)
is amended by inserting after section 505 the following
section:
``SEC. 505-1. RISK EVALUATION AND MITIGATION STRATEGIES.
``(a) Submission of Proposed Strategy.--
``(1) Initial approval.--A person who submits an
application referred to in section 505(p)(1)(A) (referred to
in this section as a `covered application') shall submit to
the Secretary as part of the application a proposed risk
evaluation and mitigation strategy if the Secretary
determines such a strategy is necessary to ensure that the
benefits of the drug involved outweigh the risks of the drug.
In making such a determination, the Secretary shall consider
the statement submitted by the person under section 505(p)(2)
with respect to the drug and shall consider the following
factors:
``(A) The estimated size of the population likely to use
the drug involved.
``(B) The seriousness of the disease or condition that is
to be treated with the drug.
``(C) The expected benefit of the drug with respect to such
disease or condition.
``(D) The expected or actual duration of treatment with the
drug.
``(E) The seriousness of any known or potential adverse
events that may be related to the drug and the background
incidence of such events in the population likely to use the
drug.
``(F) The availability and safety of a drug or other
treatment, if any, for such disease or condition to which the
safety of the drug may be compared.
``(G) Whether the drug is a new molecular entity.
``(2) Postapproval requirement.--
``(A) In general.--If the Secretary approves a covered
application and does not when approving the application
require a risk evaluation and mitigation strategy under
paragraph (1), the Secretary may subsequently require such a
strategy for the drug involved if the Secretary becomes aware
of new safety information and makes a determination that such
a strategy is necessary to ensure that the benefits of the
drug outweigh the risks of the drug.
``(B) Submission of proposed strategy.--Not later than 120
days after the Secretary notifies the holder of an approved
covered application that the Secretary has made a
determination under subparagraph (A) with respect to the drug
involved, or within such other time as the Secretary requires
to protect the public health, the holder shall submit to the
Secretary a proposed risk evaluation and mitigation strategy.
``(3) Approval of new indication for use.--The
applicability of paragraph (2) includes applicability to a
drug for which an approved covered application was in effect
on the day before the effective date of this section and for
which, on or after such effective date, the holder of the
approved application submits to the Secretary a supplemental
application seeking approval of a new indication for use of
the drug.
``(4) Abbreviated new drug applications.--The applicability
of this section to an application under section 505(j) is
subject to subsection (i).
``(b) Definitions.--For purposes of this section:
``(1) Adverse drug experience.--The term `adverse drug
experience' means any adverse event associated with the use
of a drug in humans, whether or not considered drug related,
including--
``(A) an adverse event occurring in the course of the use
of the drug in professional practice;
``(B) an adverse event occurring from an overdose of the
drug, whether accidental or intentional;
``(C) an adverse event occurring from abuse of the drug;
``(D) an adverse event occurring from withdrawal of the
drug; and
``(E) any failure of expected pharmacological action of the
drug.
``(2) Covered application.--The term `covered application'
has the meaning indicated for such term in subsection (a)(1).
``(3) New safety information.--The term `new safety
information' with respect to a drug means information about--
``(A) a serious risk or an unexpected serious risk
associated with use of the drug that the Secretary has become
aware of since the drug was approved, since the risk
evaluation and mitigation strategy was required, or since the
last assessment of the approved risk evaluation and
mitigation strategy for the drug; or
``(B) the effectiveness of the approved risk evaluation and
mitigation strategy for the drug obtained since the last
assessment of such strategy.
[[Page H7594]]
``(4) Serious adverse drug experience.--The term `serious
adverse drug experience' is an adverse event that--
``(A) results in--
``(i) death;
``(ii) an adverse drug experience that places the patient
at immediate risk of death from the adverse drug experience
as it occurred (not including an adverse drug experience that
might have caused death had it occurred in a more severe
form);
``(iii) inpatient hospitalization or prolongation of
existing hospitalization;
``(iv) a persistent or significant incapacity or
substantial disruption of the ability to conduct normal life
functions; or
``(v) a congenital anomaly or birth defect; or
``(B) based on appropriate medical judgment, may jeopardize
the patient and may require a medical or surgical
intervention to prevent an outcome described under
subparagraph (A).
``(5) Serious risk.--The term `serious risk' means a risk
of a serious adverse drug experience.
``(6) Signal of a serious risk.--The term `signal of a
serious risk' means information related to a serious adverse
drug experience associated with use of a drug and derived
from--
``(A) a clinical trial;
``(B) adverse event reports;
``(C) a postapproval study, including a study under section
505(o)(3);
``(D) peer-reviewed biomedical literature; or
``(E) data derived from a postmarket risk identification
and analysis system under section 505(k)(3).
``(7) Responsible person.--The term `responsible person'
has the meaning indicated for such term in subsection (e)(2).
``(8) Unexpected serious risk.--The term `unexpected
serious risk' means a serious adverse drug experience that is
not listed in the labeling of a drug, or that may be
symptomatically and pathophysiologically related to an
adverse drug experience identified in the labeling, but
differs from such adverse drug experience because of greater
severity, specificity, or prevalence.
``(c) Contents.--A proposed risk evaluation and mitigation
strategy under subsection (a) shall--
``(1) include the timetable required under subsection (d);
and
``(2) to the extent required by the Secretary, include
additional elements described in subsections (e) and (f).
``(d) Minimal Strategy.--For purposes of subsection (c)(1),
the risk evaluation and mitigation strategy for a drug shall
require a timetable for submission of assessments of the
strategy that--
``(1) is not less frequent than once annually for the first
3 years after the strategy is initially approved;
``(2) includes an assessment in the seventh year after the
strategy is so approved; and
``(3) subject to paragraph (2), for subsequent years--
``(A) is at a frequency specified in the strategy;
``(B) is increased or reduced in frequency as necessary as
provided for in subsection (g)(4)(A); and
``(C) is eliminated after the 3-year period described in
paragraph (1) if the Secretary determines that serious risks
of the drug have been adequately identified and assessed and
are being adequately managed.
``(e) Additional Potential Elements of Strategy.--
``(1) In general.--The Secretary may under subsection
(c)(2) require that the risk evaluation and mitigation
strategy for a drug include 1 or more of the additional
elements described in this subsection if the Secretary makes
the determination required with respect to the element
involved.
``(2) Medguide; patient package insert.--The risk
evaluation and mitigation strategy for a drug may require
that, as applicable, the person submitting the covered
application or the holder of the approved such application
(referred to in this section as the `responsible person')
develop for distribution to each patient when the drug is
dispensed--
``(A) a Medication Guide, as provided for under part 208 of
title 21, Code of Federal Regulations (or any successor
regulations); and
``(B) a patient package insert, if the Secretary determines
that such insert may help mitigate a serious risk of the
drug.
``(3) Communication plan.--The risk evaluation and
mitigation strategy for a drug may require that the
responsible person conduct a communication plan to health
care providers, if, with respect to such drug, the Secretary
determines that such plan may support implementation of an
element of the strategy. Such plan may include--
``(A) sending letters to health care providers;
``(B) disseminating information about the elements of the
risk evaluation and mitigation strategy to encourage
implementation by health care providers of components that
apply to such health care providers, or to explain certain
safety protocols (such as medical monitoring by periodic
laboratory tests); or
``(C) disseminating information to health care providers
through professional societies about any serious risks of the
drug and any protocol to assure safe use.
``(f) Restrictions on Distribution or Use.--
``(1) In general.--If the Secretary determines that a drug
shown to be effective can be safely used only if distribution
or use of such drug is restricted, the Secretary may under
subsection (c)(2) require as elements of the risk evaluation
and mitigation strategy such restrictions on distribution or
use as are needed to ensure safe use of the drug.
``(2) Assuring access and minimizing burden.--Elements of a
risk evaluation and mitigation strategy included under
paragraph (1) shall--
``(A) be commensurate with a specific serious risk listed
in the labeling of the drug;
``(B) be posted publicly by the Secretary with an
explanation of how such elements will mitigate the observed
safety risk, which posting shall be made within 30 days after
the date on which the Secretary requires the element
involved;
``(C) considering the risk referred to in subparagraph (A),
not be unduly burdensome on patient access to the drug,
considering in particular--
``(i) patients with serious or life-threatening diseases or
conditions; and
``(ii) patients who have difficulty accessing health care
(such as patients in rural or medically underserved areas);
and
``(D) to the extent practicable, so as to minimize the
burden on the health care delivery system--
``(i) conform with elements to assure safe use for other
drugs with similar, serious risks; and
``(ii) be designed to be compatible with established
distribution, procurement, and dispensing systems for drugs.
``(3) Elements.--The restrictions on distribution or use
described in paragraph (1) shall include 1 or more goals to
evaluate or mitigate a serious risk listed in the labeling of
the drug, and may require that--
``(A) health care providers that prescribe the drug have
special training or experience, or are specially certified,
which training or certification with respect to the drug is
available to any willing provider from a frontier area;
``(B) pharmacies, practitioners, or health care settings
that dispense the drug are specially certified, which
training or certification with respect to the drug is
available to any willing provider from a frontier area;
``(C) the drug be dispensed to patients only in certain
health care settings, such as hospitals;
``(D) the drug be dispensed to patients with evidence or
other documentation of safe-use conditions, such as
laboratory test results;
``(E) each patient using the drug be subject to certain
monitoring; or
``(F) each patient using the drug be enrolled in a
registry.
``(4) Implementation system.--The restrictions on
distribution or use described in paragraph (1) may require a
system through which the responsible person is able to--
``(A) monitor and evaluate implementation of the
restrictions by health care providers, pharmacists, patients,
and other parties in the health care system who are
responsible for implementing the restrictions;
``(B) work to improve implementation of the restrictions by
health care providers, pharmacists, patients, and other
parties in the health care system who are responsible for
implementing the restrictions; and
``(C) notify wholesalers of the drug of those health care
providers--
``(i) who are responsible for implementing the
restrictions; and
``(ii) whom the responsible person knows have failed to
meet their responsibilities for implementing the
restrictions, after the responsible person has informed such
party of such failure and such party has not remedied such
failure.
``(5) Limitation.--No holder of an approved application
shall use any restriction on distribution required by the
Secretary as necessary to assure safe use of the drug to
block or delay approval of an application under section
505(b)(2) or (j) or to prevent application of such
restriction under subsection (i)(1)(B) to a drug that is the
subject of an abbreviated new drug application.
``(6) Bioequivalence testing.--Notwithstanding any other
provisions in this subsection, the holder of an approved
application that is subject to distribution restrictions
required under this subsection that limit the ability of a
sponsor seeking approval of an application under subsection
505(b)(2) or (j) to purchase on the open market a sufficient
quantity of drug to conduct bioequivalence testing shall
provide to such a sponsor a sufficient amount of drug to
conduct bioequivalence testing if the sponsor seeking
approval under section 505(b)(2) or (j)--
``(A) agrees to such restrictions on distribution as the
Secretary finds necessary to assure safe use of the drug
during bioequivalence testing; and
``(B) pays the holder of the approved application the fair
market value of the drug purchased for bioequivalence
testing.
``(7) Letter by secretary.--Upon a showing by the sponsor
seeking approval under section 505(b)(2) or (j) that the
sponsor has agreed to such restrictions necessary to assure
safe use of the drug during bioequivalence testing, the
Secretary shall issue to the sponsor seeking to conduct
bioequivalence testing a letter that describes the
Secretary's finding which shall serve as proof that the
sponsor has satisfied the requirements of subparagraph
(6)(A).
``(8) Evaluation of elements to assure safe use.--The
Secretary, acting through
[[Page H7595]]
the Drug Safety and Risk Management Advisory Committee (or
any successor committee) of the Food and Drug Administration,
shall--
``(A) seek input from patients, physicians, pharmacists,
and other health care providers about how elements to assure
safe use under this subsection for 1 or more drugs may be
standardized so as not to be--
``(i) unduly burdensome on patient access to the drug; and
``(ii) to the extent practicable, minimize the burden on
the health care delivery system;
``(B) at least annually, evaluate, for 1 or more drugs, the
elements to assure safe use of such drug to assess whether
the elements--
``(i) assure safe use of the drug;
``(ii) are not unduly burdensome on patient access to the
drug; and
``(iii) to the extent practicable, minimize the burden on
the health care delivery system; and
``(C) considering such input and evaluations--
``(i) issue or modify agency guidance about how to
implement the requirements of this subsection; and
``(ii) modify elements under this subsection for 1 or more
drugs as appropriate.
``(9) Waiver in public health emergencies.--The Secretary
may waive any restriction on distribution or use under this
subsection during the period described in section 319(a) of
the Public Health Service Act with respect to a qualified
countermeasure described under section 319F-1(a)(2) of such
Act, to which a restriction or use under this subsection has
been applied, if the Secretary has--
``(A) declared a public health emergency under such section
319; and
``(B) determined that such waiver is required to mitigate
the effects of, or reduce the severity of, such public health
emergency.
``(g) Assessment and Modification of Approved Strategy.--
``(1) Voluntary assessments.--After the approval of a risk
evaluation and mitigation strategy under subsection (a), the
responsible person involved may, subject to paragraph (2),
submit to the Secretary an assessment of, and propose a
modification to, the approved strategy for the drug involved
at any time.
``(2) Required assessments.--A responsible person shall,
subject to paragraph (5), submit an assessment of, and may
propose a modification to, the approved risk evaluation and
mitigation strategy for a drug--
``(A) when submitting a supplemental application for a new
indication for use under section 505(b) or under section 351
of the Public Health Service Act, unless the drug is not
subject to section 503(b) and the risk evaluation and
mitigation strategy for the drug includes only the timetable
under subsection (d);
``(B) when required by the strategy, as provided for in
such timetable under subsection (d);
``(C) within a time period to be determined by the
Secretary, if the Secretary determines that new safety or
effectiveness information indicates that--
``(i) an element under subsection (d) or (e) should be
modified or included in the strategy; or
``(ii) an element under subsection (f) should be modified
or included in the strategy; or
``(D) within 15 days when ordered by the Secretary, if the
Secretary determines that there may be a cause for action by
the Secretary under section 505(e).
``(3) Requirements for assessments.--An assessment under
paragraph (1) or (2) of an approved risk evaluation and
mitigation strategy for a drug shall include--
``(A) with respect to any goal under subsection (f), an
assessment of the extent to which the restrictions on
distribution or use are meeting the goal or whether the goal
or such restrictions should be modified;
``(B) with respect to any postapproval study required under
section 505(o)(3), the status of such study, including
whether any difficulties completing the study have been
encountered; and
``(C) with respect to any postapproval clinical trial
required under section 505(o), the status of such clinical
trial, including whether enrollment has begun, the number of
participants enrolled, the expected completion date, whether
any difficulties completing the clinical trial have been
encountered, and registration information with respect to
requirements under section 492C of the Public Health Service
Act.
``(4) Modification.--A modification (whether an enhancement
or a reduction) to the approved risk evaluation and
mitigation strategy for a drug may include the addition or
modification of any element under subsection (d) or the
addition, modification, or removal of any element under
subsection (e) or (f), such as--
``(A) modifying the timetable for assessments of the
strategy under subsection (d), including to eliminate
assessments; or
``(B) adding, modifying, or removing a restriction on
distribution or use under subsection (f).
``(5) No effect on labeling changes that do not require
preapproval.--In the case of a labeling change to which
section 314.70 of title 21, Code of Federal Regulations (or
any successor regulation), applies for which the submission
of a supplemental application is not required or for which
distribution of the drug involved may commence upon the
receipt by the Secretary of a supplemental application for
the change, the submission of an assessment of the approved
risk evaluation and mitigation strategy for the drug under
paragraph (2) is not required.
``(h) Review of Proposed Strategies; Review of Assessments
of Approved Strategies.--
``(1) In general.--The Secretary shall promptly review each
proposed risk evaluation and mitigation strategy for a drug
submitted under subsection (a) and each assessment of an
approved risk evaluation and mitigation strategy for a drug
submitted under subsection (g).
``(2) Marketing plan.--
``(A) In general.--As part of a review conducted under this
subsection, the Secretary may require the applicant to submit
information regarding its marketing plan and practices for
the drug, so as to allow the Secretary to determine whether
any of the proposed or ongoing marketing activities undermine
any of the requirements of the risk evaluation and mitigation
strategy.
``(B) Rule of construction.--Subparagraph (A) may not be
construed as authorizing the Secretary to make or direct any
change in the marketing plan or practices involved. The
preceding sentence does not affect any authority of the
Secretary under this Act, other than the authority of the
Secretary under subparagraph (A).
``(3) Discussion.--The Secretary shall initiate discussions
with a responsible person for purposes of this subsection to
determine a strategy--
``(A) if the proposed strategy is submitted as part of an
application or supplemental application under subsection (a)
or subsection (g)(2)(A), not less than 60 days before the
action deadline for the application that has been agreed to
by the Secretary and that has been set forth in goals
identified in letters of the Secretary (relating to the use
of fees collected under section 736 to expedite the drug
development process and the process for the review of human
drug applications);
``(B) if the assessment is submitted under subparagraph (B)
or (C) or subsection (g)(2), not later than 20 days after
such submission;
``(C) if the assessment is submitted under subsection
(g)(1) or subsection (g)(2)(D) , not later than 30 days after
such submission; or
``(D) if the assessment is submitted under subsection
(g)(2)(D), not later than 10 days after such submission.
``(4) Action.--
``(A) In general.--Unless the responsible person requests
the dispute resolution process described under paragraph (5),
the Secretary shall approve and describe the risk evaluation
and mitigation strategy for a drug, or any modification to
the strategy--
``(i) as part of the action letter on the application, when
a proposed strategy is submitted under subsection (a) or an
assessment of the strategy is submitted under subsection
(g)(1); or
``(ii) in an order issued not later than 50 days after the
date discussions of such modification begin under paragraph
(3), when an assessment of the strategy is submitted under
subsection (g)(1) or under any of subparagraphs (B) through
(D) of subsection (g)(2).
``(B) Inaction.--An approved risk evaluation and mitigation
strategy shall remain in effect until the Secretary acts, if
the Secretary fails to act as provided under subparagraph
(A).
``(C) Public availability.--Any action letter described in
subparagraph (A)(i) or order described in subparagraph
(A)(ii) shall be made publicly available.
``(5) Dispute resolution.--
``(A) Request for review.--
``(i) In general.--Not earlier than 15 days, and not later
than 35 days, after discussions under paragraph (3) have
begun, the responsible person may request in writing that a
dispute about the strategy be reviewed by the Drug Safety
Oversight Board under subsection (j), except that the
determination of the Secretary to require a risk evaluation
and mitigation strategy is not subject to review under this
paragraph. The preceding sentence does not prohibit review
under this paragraph of the particular elements of such a
strategy.
``(ii) Scheduling.--Upon receipt of a request under clause
(i), the Secretary shall schedule the dispute involved for
review under subparagraph (B) and, not later than 5 business
days of scheduling the dispute for review, shall publish by
posting on the Internet or otherwise a notice that the
dispute will be reviewed by the Drug Safety Oversight Board.
``(B) Scheduling review.--If a responsible person requests
review under subparagraph (A), the Secretary--
``(i) shall schedule the dispute for review at 1 of the
next 2 regular meetings of the Drug Safety Oversight Board,
whichever meeting date is more practicable; or
``(ii) may convene a special meeting of the Drug Safety
Oversight Board to review the matter more promptly, including
to meet an action deadline on an application (including a
supplemental application).
``(C) Agreement after discussion or administrative
appeals.--
``(i) Further discussion or administrative appeals.--A
request for review under subparagraph (A) shall not preclude
further discussions to reach agreement on the risk evaluation
and mitigation strategy, and such a request shall not
preclude the use of administrative appeals within the Food
and
[[Page H7596]]
Drug Administration to reach agreement on the strategy,
including appeals as described in letters of the Secretary
(relating to the use of fees collected under section 736 to
expedite the drug development process and the process for the
review of human drug applications) for procedural or
scientific matters involving the review of human drug
applications and supplemental applications that cannot be
resolved at the divisional level.
``(ii) Agreement terminates dispute resolution.--At any
time before a decision and order is issued under subparagraph
(G) , the Secretary and the responsible person may reach an
agreement on the risk evaluation and mitigation strategy
through further discussion or administrative appeals,
terminating the dispute resolution process, and the Secretary
shall issue an action letter or order, as appropriate, that
describes the strategy.
``(D) Meeting of the board.--At a meeting of the Drug
Safety Oversight Board described in subparagraph (B), the
Board shall--
``(i) hear from both parties; and
``(ii) review the dispute.
``(E) Record of proceedings.--The Secretary shall ensure
that the proceedings of any such meeting are recorded,
transcribed, and made public within 30 days of the meeting.
The Secretary shall redact the transcript to protect any
trade secrets or other confidential information described in
section 552(b)(4) of title 5, United States Code.
``(F) Recommendation of the board.--Not later than 5 days
after any such meeting, the Drug Safety Oversight Board shall
provide a written recommendation on resolving the dispute to
the Secretary. Not later than 5 days after the Board provides
such written recommendation to the Secretary, the Secretary
shall make the recommendation available to the public.
``(G) Action by the secretary.--
``(i) Action letter.--With respect to a proposal or
assessment referred to in paragraph (1), the Secretary shall
issue an action letter that resolves the dispute not later
than the later of--
``(I) the action deadline referred to in paragraph (3)(A);
or
``(II) 7 days after receiving the recommendation of the
Drug Safety Oversight Board.
``(ii) Order.--With respect to an assessment of an approved
risk evaluation and mitigation strategy under subsection
(g)(1) or under any of subparagraphs (B) through (D) of
subsection (g)(2), the Secretary shall issue an order, which
shall be made public, that resolves the dispute not later
than 7 days after receiving the recommendation of the Drug
Safety Oversight Board.
``(H) Inaction.--An approved risk evaluation and mitigation
strategy shall remain in effect until the Secretary acts, if
the Secretary fails to act as provided for under subparagraph
(G).
``(I) Effect on action deadline.--With respect to a
proposal or assessment referred to in paragraph (1), the
Secretary shall be considered to have met the action deadline
referred to in paragraph (3)(A) with respect to the
application involved if the responsible person requests the
dispute resolution process described in this paragraph and if
the Secretary--
``(i) has initiated the discussions described under
paragraph (3) not less than 60 days before such action
deadline; and
``(ii) has complied with the timing requirements of
scheduling review by the Drug Safety Oversight Board,
providing a written recommendation, and issuing an action
letter under subparagraphs (B), (F), and (G), respectively.
``(J) Disqualification.--No individual who is an employee
of the Food and Drug Administration and who reviews a drug or
who participated in an administrative appeal under
subparagraph (C)(i) with respect to such drug may serve on
the Drug Safety Oversight Board at a meeting under
subparagraph (D) to review a dispute about the risk
evaluation and mitigation strategy for such drug.
``(K) Additional expertise.--The Drug Safety Oversight
Board may add members with relevant expertise from the Food
and Drug Administration, including the Office of Pediatrics,
the Office of Women's Health, or the Office of Rare Diseases,
or from other Federal public health or health care agencies,
for a meeting under subparagraph (D) of the Drug Safety
Oversight Board.
``(6) Use of advisory committees.--The Secretary may
convene a meeting of 1 or more advisory committees of the
Food and Drug Administration to--
``(A) review a concern about the safety of a drug or class
of drugs, including before an assessment of the risk
evaluation and mitigation strategy or strategies of such drug
or drugs is required to be submitted under any of
subparagraphs (B) through (D) of subsection (g)(2);
``(B) review the risk evaluation and mitigation strategy or
strategies of a drug or group of drugs; or
``(C) review a dispute under paragraph (5).
``(7) Process for addressing drug class effects.--
``(A) In general.--When a concern about a serious risk of a
drug may be related to the pharmacological class of the drug,
the Secretary may defer assessments of the approved risk
evaluation and mitigation strategies for such drugs until the
Secretary has convened 1 or more public meetings to consider
possible responses to such concern. If the Secretary defers
an assessment under this subparagraph, the Secretary shall
give notice to the public of the deferral not later than 5
days of the deferral.
``(B) Public meetings.--Such public meetings may include--
``(i) 1 or more meetings of the reviewed entities for such
drugs;
``(ii) 1 or more meetings of 1 or more advisory committees
of the Food and Drug Administration, as provided for under
paragraph (6); or
``(iii) 1 or more workshops of scientific experts and other
stakeholders.
``(C) Action.--After considering the discussions from any
meetings under subparagraph (B), the Secretary may--
``(i) announce in the Federal Register a planned regulatory
action, including a modification to each risk evaluation and
mitigation strategy, for drugs in the pharmacological class;
``(ii) seek public comment about such action; and
``(iii) after seeking such comment, issue an order
addressing such regulatory action.
``(8) International coordination.--The Secretary may
coordinate the timetable for submission of assessments under
subsection (d), or a study or clinical trial under section
505(o)(3), with efforts to identify and assess the serious
risks of such drug by the marketing authorities of other
countries whose drug approval and risk management processes
the Secretary deems comparable to the drug approval and risk
management processes of the United States. If the Secretary
takes action to coordinate such timetable, the Secretary
shall give notice to the public of the action not later than
5 days after the action.
``(9) Effect.--Use of the processes described in paragraphs
(7) and (8) shall not delay action on an application or a
supplement to an application for a drug.
``(i) Abbreviated New Drug Applications.--
``(1) In general.--A drug that is the subject of an
abbreviated new drug application under section 505(j) is
subject to only the following elements of the risk evaluation
and mitigation strategy required under subsection (a) for the
applicable listed drug:
``(A) A Medication Guide or patient package insert, if
required under subsection (e) for the applicable listed drug.
``(B) Restrictions on distribution or use, if required
under subsection (f) for the listed drug. A drug that is the
subject of an abbreviated new drug application and the listed
drug shall use a single, shared system under subsection
(f)(4). The Secretary may waive the requirement under the
preceding sentence for a drug that is the subject of an
abbreviated new drug application if the Secretary determines
that--
``(i) it is not practical for the drug to use such single,
shared system; or
``(ii) the burden of using the single, shared system
outweighs the benefit of using the single system.
``(2) Action by secretary.--For an applicable listed drug
for which a drug is approved under section 505(j), the
Secretary--
``(A) shall undertake any communication plan to health care
providers required under subsection (e)(3) for the applicable
listed drug; and
``(B) shall inform the responsible person for the drug that
is so approved if the risk evaluation and mitigation strategy
for the applicable listed drug is modified.
``(j) Drug Safety Oversight Board.--
``(1) In general.--There is established a Drug Safety
Oversight Board.
``(2) Composition; meetings.--The Drug Safety Oversight
Board shall--
``(A) be composed of scientists and health care
practitioners appointed by the Secretary, each of whom is an
employee of the Federal Government;
``(B) include representatives from offices throughout the
Food and Drug Administration;
``(C) include at least 1 representative from each of the
National Institutes of Health and the Department of Health
and Human Services (other than the Food and Drug
Administration);
``(D) include such representatives as the Secretary shall
designate from other appropriate agencies that wish to
provide representatives; and
``(E) meet at least monthly to provide oversight and advice
to the Secretary on the management of important drug safety
issues.''.
(c) Regulation of Biological Products.--Section 351 of the
Public Health Service Act (42 U.S.C. 262) is amended--
(1) in subsection (a)(2), by adding at the end the
following:
``(D) Risk Evaluation and Mitigation Strategy.--A person
that submits an application for a license under this
paragraph is subject to section 505(p) of the Federal Food,
Drug, and Cosmetic Act.''; and
(2) in subsection (j), by inserting ``, including the
requirements under section 505(p) of such Act,'' after ``,
and Cosmetic Act''.
(d) Prereview of Advertisements.--
(1) Sense of congress.--It is the sense of the Congress
that--
(A) ``Guidance for Industry Consumer-Directed Broadcast
Advertisements'' issued by the Food and Drug Administration
in August, 1999, represents generally good guidance for
direct-to-consumer (DTC) advertising of prescription
medicines and other treatments;
(B) direct-to-consumer advertising as an accurate source of
health information for all populations, specifically
including the elderly populations, children, chronically ill
and racial and ethnic minority populations,
[[Page H7597]]
should be made more reliable by ensuring the truth and
credibility of information provided through such advertising;
and
(C) the Congress will work with the Food and Drug
Administration to ensure that information provided through
direct-to-consumer advertising of prescription medicines and
other treatments is not false or misleading and communicates
clearly and sensitively to all communities.
(2) Prereview.--The Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.) is amended--
(A) in section 301 (21 U.S.C. 331), by adding at the end
the following:
``(jj) The dissemination of a television advertisement
without complying with section 503B.''; and
(B) by inserting after section 503A the following:
``SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS.
``(a) In General.--The Secretary may require the submission
of any television advertisement for a drug (including any
script, story board, rough, or a completed video production
of the television advertisement) to the Secretary for review
under this section not later than 45 days before
dissemination of the television advertisement.
``(b) Review.--In conducting a review of a television
advertisement under this section, the Secretary may make
recommendations--
``(1) on changes that are--
``(A) necessary to protect the consumer good and well-
being; or
``(B) consistent with prescribing information for the
product under review; and
``(2) if appropriate and if information exists, on
statements for inclusion in the advertisement to address the
specific efficacy of the drug as it relates to a specific
population group, including elderly populations, children,
and racially and ethnically diverse populations.
``(c) No Authority To Require Changes.--This section does
not authorize the Secretary to make or direct changes in any
material submitted pursuant to subsection (a).
``(d) Elderly Populations, Children, Racially and
Ethnically Diverse Communities.--In formulating
recommendations under subsection (b), the Secretary shall
take into consideration the impact of the advertised drug on
elderly populations, children, and racially and ethnically
diverse communities.
``(e) Specific Disclosures.--
``(1) Serious risk; safety protocol.--In conducting a
review of a television advertisement under this section, if
the Secretary determines that the advertisement would be
false or misleading without a specific disclosure about a
serious risk listed in the labeling of the drug involved, the
Secretary may require inclusion of such disclosure in the
advertisement.
``(2) Date of approval.--In conducting a review of a
television advertisement under this section, the Secretary
may require the advertisement to include, for a period not to
exceed 2 years from the date of the approval of the drug
under section 505, a specific disclosure of such date of
approval if the Secretary determines that the advertisement
would otherwise be false or misleading.
``(f) Rule of Construction.--Nothing in this section may be
construed as having any effect on the authority of the
Secretary under section 314.550, 314.640, 601.45, or 601.94
of title 21, Code of Federal Regulations (or successor
regulations).''.
(3) Direct-to-consumer advertisements.--
(A) In general.--Section 502(n) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352(n)) is amended by adding at
the end the following: ``In the case of an advertisement for
a drug subject to section 503(b)(1) presented directly to
consumers in television or radio format and stating the name
of the drug and its conditions of use, the major statement
relating to side effects and contraindications shall be
presented in a clear and conspicuous manner.''.
(B) Regulations to determine clear and conspicuous
manner.--The Secretary of Health and Human Services shall by
regulation establish standards for determining whether a
major statement relating to side effects and
contraindications of a drug, described in section 502(n) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n))
(as amended by subparagraph (A)) is presented in the manner
required under such section.
(4) Civil penalties.--Section 303 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333) is amended--
(A) by redesignating subsection (g) (relating to civil
penalties) as subsection (f); and
(B) by adding at the end the following:
``(g)(1) With respect to a person who is a holder of an
approved application under section 505 for a drug subject to
section 503(b) or under section 351 of the Public Health
Service Act, any such person who disseminates a direct-to-
consumer advertisement that is false or misleading shall be
liable to the United States for a civil penalty in an amount
not to exceed $250,000 for the first such violation in any 3-
year period, and not to exceed $500,000 for each subsequent
violation in any 3-year period. No other civil monetary
penalties in this Act (including the civil penalty in section
303(f)(3)) shall apply to a violation regarding direct-to-
consumer advertising. For purposes of this paragraph: (A)
Repeated dissemination of the same or similar advertisement
prior to the receipt of the written notice referred to in
paragraph (2) for such advertisements shall be considered one
violation. (B) On and after the date of the receipt of such a
notice, all violations under this paragraph occurring in a
single day shall be considered one violation
``(2) A civil penalty under paragraph (1) shall be assessed
by the Secretary by an order made on the record after
providing written notice to the person to be assessed a civil
penalty and an opportunity for a hearing in accordance with
this paragraph and section 554 of title 5, United States
Code. If upon receipt of the written notice, the person to be
assessed a civil penalty objects and requests a hearing, then
in the course of any investigation related to such hearing,
the Secretary may issue subpoenas requiring the attendance
and testimony of witnesses and the production of evidence
that relates to the matter under investigation, including
information pertaining to the factors described in paragraph
(3).
``(3) Upon the request of the person to be assessed a civil
penalty under paragraph (1), the Secretary, in determining
the amount of the civil penalty, shall take into account the
nature, circumstances, extent, and gravity of the violation
or violations, including the following factors:
``(A) Whether the person submitted the advertisement or a
similar advertisement for review under section 736A.
``(B) Whether the person submitted the advertisement for
review if required under section 503B.
``(C) Whether, after submission of the advertisement as
described in subparagraph (A) or (B), the person disseminated
the advertisement before the end of the 45-day comment
period.
``(D) Whether the person incorporated any comments made by
the Secretary with regard to the advertisement into the
advertisement prior to its dissemination.
``(E) Whether the person ceased distribution of the
advertisement upon receipt of the written notice referred to
in paragraph (2) for such advertisement.
``(F) Whether the person had the advertisement reviewed by
qualified medical, regulatory, and legal reviewers prior to
its dissemination.
``(G) Whether the violations were material.
``(H) Whether the person who created the advertisement
acted in good faith.
``(I) Whether the person who created the advertisement has
been assessed a civil penalty under this provision within the
previous 1-year period.
``(J) The scope and extent of any voluntary, subsequent
remedial action by the person.
``(K) Such other matters, as justice may require.
``(4)(A) Subject to subparagraph (B), no person shall be
required to pay a civil penalty under paragraph (1) if the
person submitted the advertisement to the Secretary and
disseminated such advertisement after incorporating any
comment received from the Secretary other than a
recommendation subject to subsection 503B(c).
``(B) The Secretary may retract or modify any prior
comments the Secretary has provided to an advertisement
submitted to the Secretary based on new information or
changed circumstances, so long as the Secretary provides
written notice to the person of the new views of the
Secretary on the advertisement and provides a reasonable time
for modification or correction of the advertisement prior to
seeking any civil penalty under paragraph (1).
``(5) The Secretary may compromise, modify, or remit, with
or without conditions, any civil penalty which may be
assessed under paragraph (1). The amount of such penalty,
when finally determined, or the amount charged upon in
compromise, may be deducted from any sums owed by the United
States to the person charged.
``(6) Any person who requested, in accordance with
paragraph (2), a hearing with respect to the assessment of a
civil penalty and who is aggrieved by an order assessing a
civil penalty, may file a petition for de novo judicial
review of such order with the United States Court of Appeals
for the District of Columbia Circuit or for any other circuit
in which such person resides or transacts business. Such a
petition may only be filed within the 60-day period beginning
on the date the order making such assessments was issued.
``(7) On an annual basis, the Secretary shall report to the
Congress on direct-to-consumer advertising and its ability to
communicate to subsets of the general population, including
elderly populations, children, and racial and ethnic minority
communities. The Secretary shall establish a permanent
advisory committee to advise the Secretary with respect to
such report. The membership of the advisory committee shall
consist of nationally recognized medical, advertising, and
communications experts, including experts representing
subsets of the general population. The members of the
advisory committee shall serve without pay, but may receive
travel expenses, including per diem in lieu of subsistence in
accordance with applicable provisions under subchapter I of
chapter 57 of title 5, United States Code. The advisory
committee shall study direct-to-consumer advertising as it
relates to increased access to health information and
decreased health disparities for these populations. The
annual report required by this paragraph shall recommend
effective ways to present and disseminate information to
these populations. Such report shall also make
recommendations regarding impediments to the
[[Page H7598]]
participation of elderly populations, children, racially and
ethnically diverse communities, and medically underserved
populations in clinical drug trials and shall recommend best
practice approaches for increasing the inclusion of such
subsets of the general population. The Secretary shall submit
the first annual report under this paragraph to the Committee
on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of
Representatives not later than 18 months after the advisory
committee has been convened by the Secretary.
``(8) If any person fails to pay an assessment of a civil
penalty under paragraph (1)--
``(A) after the order making the assessment becomes final,
and if such person does not file a petition for judicial
review of the order in accordance with paragraph (6), or
``(B) after a court in an action brought under paragraph
(6) has entered a final judgment in favor of the Secretary,
the Attorney General of the United States shall recover the
amount assessed (plus interest at currently prevailing rates
from the date of the expiration of the 60-day period referred
to in paragraph (6) or the date of such final judgment, as
the case may be) in an action brought in any appropriate
district court of the United States. In such an action, the
validity, amount, and appropriateness of such penalty shall
not be subject to review.''.
(e) Rule of Construction Regarding Pediatric Studies.--This
title and the amendments made by this title may not be
construed as affecting the authority of the Secretary of
Health and Human Services to request pediatric studies under
section 505A of the Federal Food, Drug, and Cosmetic Act or
to require such studies under section 505B of such Act.
SEC. 902. ENFORCEMENT.
(a) Misbranding.--Section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352) is amended by adding at the
end the following:
``(y) If it is a drug subject to an approved risk
evaluation and mitigation strategy pursuant to section 505(p)
and the person responsible for complying with the strategy
fails to comply with a requirement of such strategy provided
for under subsection (d), (e), or (f) of section 505-1.
``(z) If it is a drug, and the responsible person (as such
term is used in section 505(o)) is in violation of a
requirement established under paragraph (3) (relating to
postmarket studies and clinical trials) or paragraph (4)
(relating to labeling) of section 505(o) with respect to such
drug.''.
(b) Civil Penalties.--Section 303(f) of the Federal Food,
Drug, and Cosmetic Act, as redesignated by section 901(d)(4),
is amended--
(1) by redesignating paragraphs (3), (4), and (5) as
paragraphs (4), (5), and (6), respectively;
(2) by inserting after paragraph (2) the following:
``(3) Any applicant (as such term is used in section 505-1)
who violates a requirement of section 505(o), section 505(p),
or section 505-1 shall be subject to a civil monetary penalty
of--
``(A) not more than $250,000 per violation, and not to
exceed $1,000,000 for all such violations adjudicated in a
single proceeding; or
``(B) in the case of a violation that continues after the
Secretary provides notice of such violation to the applicant,
not more than $10,000,000 per violation, and not to exceed
$50,000,000 for all such violations adjudicated in a single
proceeding.
If a violation referred to in subparagraph (A) or (B) is
continuing in nature and poses a substantial threat to the
public health, the Secretary may impose a civil penalty not
to exceed $1,000,000 per day during such time period such
person is in violation.'';
(3) in paragraph (2)(C), by striking ``paragraph (3)(A)''
and inserting ``paragraph (4)(A)'';
(4) in paragraph (4), as so redesignated, by striking
``paragraph (1) or (2)'' each place it appears and inserting
``paragraph (1), (2), or (3)''; and
(5) in paragraph (6), as so redesignated, by striking
``paragraph (4)'' each place it appears and inserting
``paragraph (5)''.
SEC. 903. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.
Section 505(e) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(e)) is amended by adding at the end the
following: ``The Secretary may withdraw the approval of an
application submitted under this section, or suspend the
approval of such an application, as provided under this
subsection, without first ordering the applicant to submit an
assessment of the approved risk evaluation and mitigation
strategy for the drug under section 505-1(g)(2)(D).''.
SEC. 904. BENEFIT-RISK ASSESSMENTS.
Not later than 1 year after the date of the enactment of
this Act, the Commissioner of Food and Drugs shall submit to
the Congress a report on how best to communicate to the
public the risks and benefits of new drugs and the role of
the risk evaluation and mitigation strategy in assessing such
risks and benefits. As part of such study, the Commissioner
shall consider the possibility of including in the labeling
and any direct-to-consumer advertisements of a newly approved
drug or indication a unique symbol indicating the newly
approved status of the drug or indication for a period after
approval.
SEC. 905. POSTMARKET RISK IDENTIFICATION AND ANALYSIS SYSTEM
FOR ACTIVE SURVEILLANCE AND ASSESSMENT.
(a) Findings.--Congress finds the following:
(1) It is in the best interests of healthcare providers and
patients that a postmarketing surveillance system be
developed that will enable active surveillance of disparate
sources of data to identify signals of unexpected adverse
events and trends in the frequency of known adverse events,
to provide data on the outcomes of off label uses, and to
enable identification of safety issues earlier than can be
done today.
(2) Such a system can best be developed through public
private partnerships to develop methods and tools for
conducting surveillance using electronic databases that
currently contain data on millions of patient encounters and
are expected to grow significantly in the next decade, as
well as electronic databases that contain millions of medical
product purchases, health care claims, and similar
information relevant to product use, efficacy, and safety.
(3) Therefore, this section directs the Secretary of Health
and Human Services to enter into such public private
partnerships as are necessary to develop such a surveillance
system and the tools and methods necessary to conduct active
surveillance using the system.
(b) Development of the Postmarket Risk Identification and
Analysis System.--Subsection (k) of section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is
amended by adding at the end the following:
``(3) The Secretary shall establish public private
partnerships to develop tools and methods to enable the
Secretary and others to use available electronic databases to
create a robust surveillance system that will support active
surveillance on important drug safety questions including
detecting and assessing drug safety signals; monitoring the
frequency of known adverse events; and evaluating the
outcomes of off label uses. Such surveillance shall provide
for adverse event surveillance using the following data
sources:
``(A) Federal health-related electronic data (such as data
from the Medicare program and the health systems of the
Department of Veterans Affairs).
``(B) Private sector health-related electronic data (such
as pharmaceutical purchase data and health insurance claims
data).
``(C) Other information as the Secretary deems useful to
create a robust system to identify and assess adverse events
and potential drug safety signals and to evaluate the extent
and outcomes of off label uses of drugs.
``(4) Not later than 1 year after the date of the enactment
of this paragraph, the Secretary, in consultation with
experts including individuals who are recognized in the field
of data privacy and security, shall develop methods for
integrating and analyzing safety data from multiple sources
and mechanisms for obtaining access to such data. Such
methods and mechanisms shall not compromise the protection of
individually identifiable health information.
``(5) Not later than 2 years after the date of the
enactment of this paragraph, the Secretary shall have entered
into partnerships that will allow the analysis of available
data from the various data sources using the standards and
methods to identify drug safety signals and trends. Such
analysis shall not disclose individually identifiable health
information when presenting such drug safety signals and
trends or when responding to inquiries regarding such drug
safety signals and trends.
``(6) Not later than 4 years after the date of the
enactment of this paragraph, the Secretary shall report to
the Congress on the ways in which the Secretary has used the
surveillance system described in this subsection to identify
specific drug safety signals and to better understand the
outcomes associated with drugs marketed in the United States.
``(7) Disclosure of individually identifiable information
is prohibited in the surveillance system described in this
subsection. Nothing in this subsection prohibits lawful
disclosure of such information for other purposes.
``(8) Nothing in this subsection shall be construed as
limiting public health activities authorized under law.''.
(c) Authorization of Appropriations.--To carry out
activities under the amendment made by subsection (b) for
which funds are made available under section 736 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), there
are authorized to be appropriated, in addition to such funds,
$25,000,000 for each of fiscal years 2008 through 2012.
(d) GAO Report.--Not later than 18 months after the date of
the enactment of this Act, the Comptroller General of the
United States shall evaluate data confidentiality and
security issues relating to collection, transmission, and
maintenance of data for the surveillance system developed
pursuant to this section, and make recommendations to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, Labor
and Pensions of the Senate, and any other congressional
committees of relevant jurisdiction, regarding the need for
any additional legislative or regulatory actions to ensure
confidentiality and security of this data or otherwise
address confidentiality and security issues to ensure the
effective operation of the surveillance system.
[[Page H7599]]
SEC. 907. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER
ADVERTISEMENTS OF DRUGS.
Section 502(n) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352), as amended by section 901(d)(3), is further
amended by striking ``of this Act, except that'' and
inserting ``of this Act, and in the case of any direct-to-
consumer advertisement the following statement: `You are
encouraged to report adverse effects of prescription drug
medication to the FDA. Log onto www.fda.gov/medwatch or call
1-800-FDA-1088.', except that''.
SEC. 908. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.
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. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.
``(a) In General.--Not later than 1 year after the date of
enactment of this section, the Secretary, acting through the
Commissioner of Food and Drugs, shall issue guidance for the
conduct of clinical trials with respect to antibiotic drugs,
including antimicrobials to treat acute bacterial sinusitis,
acute bacterial otitis media, and acute bacterial
exacerbation of chronic bronchitis. Such guidelines shall
indicate the appropriate animal models of infection, in vitro
techniques, and valid microbiologic surrogate markers.
``(b) Review.--Not later than 5 years after the date of
enactment of this section, the Secretary, acting through the
Commissioner of Food and Drugs, shall review and update the
guidance described under subsection (a) to reflect
developments in scientific and medical information and
technology.''.
SEC. 909. PROHIBITION AGAINST FOOD TO WHICH DRUGS OR
BIOLOGICAL PRODUCTS HAVE BEEN ADDED.
Section 301 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331), as amended by section 901(d)(2)(A), is amended
by adding at the end the following:
``(kk) The introduction or delivery for introduction into
interstate commerce of any food to which has been added--
``(1) a drug approved under section 505,
``(2) a biological product licensed under section 351 of
the Public Health Service Act, or
``(3) a drug or biological product for which substantial
clinical investigations have been instituted and for which
the existence of such investigations has been made public,
unless such drug or biological product was marketed in food
before any approval of the drug under section 505 of this
Act, before licensure of the biological product under section
351 of the Public Health Service Act, and before any
substantial clinical investigations involving the drug or
biological product have been instituted, or unless the
Secretary, in the Secretary's discretion, has issued a
regulation, after notice and comment, approving the addition
of such drug or biological product to the food.''.
SEC. 910. ASSURING PHARMACEUTICAL SAFETY.
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. PHARMACEUTICAL SECURITY.
``(a) In General.--The Secretary shall develop standards
and identify and validate effective technologies for the
purpose of securing the prescription drug distribution system
against counterfeit, diverted, subpotent, substandard,
adulterated, misbranded, or expired drugs.
``(b) Standards Development.--
``(1) In general.--The Secretary shall, in consultation
with the agencies specified in paragraph (3), prioritize and
develop standards for the identification, validation,
authentication, and tracking of prescription drugs.
``(2) Promising technologies.--The standards developed
under this subsection shall address promising technologies,
including--
``(A) radio frequency identification technology;
``(B) nanotechnology;
``(C) encryption technologies; and
``(D) other track-and-trace technologies.
``(3) Interagency collaboration.--In carrying out this
subsection, the Secretary shall consult with Federal health
and security agencies, including--
``(A) the Administrator of the Drug Enforcement
Administration;
``(B) the Secretary of the Department of Homeland Security;
``(C) the Secretary of Commerce; and
``(D) other appropriate Federal and State agencies.
``(c) Inspection and Enforcement.--
``(1) In general.--The Secretary shall expand and enhance
the resources and facilities of the Office of Regulatory
Affairs of the Food and Drug Administration to protect the
prescription drug distribution system against counterfeit,
diverted, subpotent, substandard, adulterated, misbranded, or
expired drugs.
``(2) Activities.--The Secretary shall undertake enhanced
and joint enforcement activities with other Federal agencies
and State officials, and establish regional capacities for
the validation of prescription drugs and the inspection of
the prescription drug distribution system.
``(d) Definition.--In this section, the term `prescription
drug' means a drug subject to section 503(b)(1).''.
SEC. 911. ORPHAN ANTIBIOTIC DRUGS.
(a) Public Meeting.--The Commissioner of Food and Drugs
shall convene a public meeting regarding which serious and
life threatening infectious diseases, such as diseases due to
gram-negative bacteria and other diseases due to antibiotic-
resistant bacteria, potentially qualify for available grants
and contracts under section 5(a) of the Orphan Drug Act (21
U.S.C. 360ee(a)) or other incentives for development.
(b) Grants and Contracts for the Development of Orphan
Drugs.--Section 5(c) of the Orphan Drug Act (21 U.S.C.
360ee(c)) is amended to read as follows:
``(c) For grants and contracts under subsection (a), there
is authorized to be appropriated $30,000,000 for each of
fiscal years 2008 through 2012.''.
SEC. 912. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY
ACTION.
(a) In General.--Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), as amended by section 901(a),
is amended by adding at the end the following:
``(q) Petitions and Civil Actions Regarding Approval of
Certain Applications.--
``(1) In general.--With respect to a pending application
under subsection (b)(2) or (j), if a petition is submitted to
the Secretary that seeks to have the Secretary take, or
refrain from taking, any form of action relating to the
approval of the application, including a delay in the
effective date of the application, the following applies,
subject to paragraph (5):
``(A) The Secretary may not, on the basis of the petition,
delay approval of the application unless the Secretary
determines that a delay is necessary to protect the public
health and provides the applicant with a written explanation
of the reasons for the delay. Consideration of a petition
shall be separate and apart from the review and approval of
the application.
``(B) The Secretary shall take final agency action on the
petition not later than 180 days after the date on which the
petition is submitted. The Secretary shall not extend such
period, even with the consent of the petitioner, for any
reason, including based upon the submission of comments
relating to the petition or supplemental information supplied
by the petitioner.
``(C) If the Secretary determines that the petition was
submitted with the primary purpose of delaying approval of a
drug under subsection (b)(2) or (j), the Secretary may deny
the petition at any point.
``(D) If the filing of the application resulted in first-
applicant status under subsection (j)(5)(D)(i)(IV), the 30-
month period under such subsection is deemed to be extended
by a period of time equal to the period beginning on the date
on which the Secretary received the petition and ending on
the date of final agency action on the petition (inclusive of
such beginning and ending dates), without regard to whether
the Secretary grants, in whole or in part, or denies, in
whole or in part, the petition.
``(E) The Secretary may not consider the petition for
review unless it is signed and contains the following
certification: `I certify that, to my best knowledge and
belief: (a) this petition includes all information and views
upon which the petition relies; (b) this petition includes
representative data and/or information known to the
petitioner which are unfavorable to the petition; and (c) I
have taken reasonable steps to ensure that any representative
data and/or information which are unfavorable to the petition
were disclosed to me. I further certify that the information
upon which I have based the action requested herein first
became known to the party on whose behalf this petition is
submitted on or about the following date: __________. I
received or expect to receive payments, including cash and
other forms of consideration, from the following persons or
organizations to file this petition: _____________. I verify
under penalty of perjury that the foregoing is true and
correct.'.
``(2) Exhaustion of administrative remedies.--
``(A) Final agency action within 180 days.--The Secretary
shall be considered to have taken final agency action on a
petition referred to in paragraph (1) if--
``(i) during the 180-day period referred to in subparagraph
(B) of such paragraph, the Secretary makes a final decision
within the meaning of section 10.45(d) of title 21, Code of
Federal Regulations (or any successor regulation); or
``(ii) such period expires without the Secretary having
made such a final decision.
``(B) Dismissal of certain civil actions.--If a civil
action is filed with respect to any issue raised in a
petition under paragraph (1) before the Secretary has taken
final agency action on the petition within the meaning of
subparagraph (A), the court shall dismiss the action for
failure to exhaust administrative remedies.
``(3) Applicability of certain regulations.--The provisions
of this section are in addition to the requirements for the
submission of a petition to the Secretary that apply under
section 10.30 or 10.35 of title 21, Code of Federal
Regulations (or any successor regulations).
``(4) Annual report on delays in approvals per petitions.--
The Secretary shall annually submit to the Congress a report
that specifies--
``(A) the number of applications under subsections (b)(2)
and (j) that were approved during the preceding 12-month
period;
[[Page H7600]]
``(B) the number of such applications whose effective dates
were delayed by petitions referred to in paragraph (1) during
such period; and
``(C) the number of days by which the applications were so
delayed.
``(5) Exceptions.--This subsection does not apply to--
``(A) a petition that relates solely to the timing of the
approval of an application pursuant to subsection
(j)(5)(B)(iv); or
``(B) a petition that is made by the sponsor of an
application under subsection (b)(2) or (j) and that seeks
only to have the Secretary take or refrain from taking any
form of action with respect to that application.
``(6) Definition.--For purposes of this subsection, the
term `petition' includes any request to the Secretary for an
action described in paragraph (1), without regard to whether
the request is characterized as a petition.''.
(b) Report.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human
Services shall submit a report to the Congress on ways to
encourage the early submission of petitions under section
505(q), as added by subsection (a).
SEC. 913. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--For carrying out this title and the
amendments made by this title, there is authorized to be
appropriated $25,000,000 for each of fiscal years 2008
through 2012.
(b) Relation to Other Funding.--The authorization of
appropriations under subsection (a) is in addition to any
other funds available for carrying out this title and the
amendments made by this title.
SEC. 914. EFFECTIVE DATE AND APPLICABILITY.
(a) Effective Date.--This title takes effect 180 days after
the date of the enactment of this Act.
(b) Drugs Deemed to Have Risk Evaluation and Mitigation
Strategies.--
(1) In general.--A drug that was approved before the
effective date of this Act is, in accordance with paragraph
(2), deemed to have in effect an approved risk evaluation and
mitigation strategy under section 505-1 of the Federal Food,
Drug, and Cosmetic Act (as added by section 901 of this
title) (referred to in this section as the ``Act'' ) if there
are in effect on the effective date of this Act restrictions
on distribution or use--
(A) required under section 314.520 or section 601.42 of
title 21, Code of Federal Regulations; or
(B) otherwise agreed to by the applicant and the Secretary
for such drug.
(2) Elements of strategy; enforcement.--The approved risk
evaluation and mitigation strategy in effect for a drug under
paragraph (1)--
(A) is deemed to consist of the elements described in
paragraphs (1) and (2) of section 505-1(d) of the Act and any
additional elements under subsections (d) and (e) of such
section in effect for such drug on the effective date of this
Act; and
(B) is subject to enforcement by the Secretary to the same
extent as any other risk evaluation and mitigation strategy
under section 505-1 of the Act.
(3) Submission.--Not later than 180 days after the
effective date of this Act, the holder of an approved
application for which a risk evaluation and mitigation
strategy is deemed to be in effect under paragraph (1) shall
submit to the Secretary a proposed risk evaluation and
mitigation strategy. Such proposed strategy is subject to
section 505-1 of the Act as if included in such application
at the time of submission of the application to the
Secretary.
(c) Other Drugs Approved Before the Effective Date.--The
Secretary, on a case-by-case basis, may require the holder of
an application approved before the effective date of this Act
to which subsection (b) does not apply to submit a proposed
risk evaluation and mitigation strategy in accordance with
the timeframes provided for in subparagraphs (C) through (D)
of section 505-1(g)(2) of the Act if the Secretary determines
(with respect to such drug or with respect to the group of
drugs to which such drug belongs) that--
(1) an element described under section 505-1(d)(1) of the
Act may require modification; or
(2) a standard for adding an element described in
subsection (e) or (d) of section 505-1 of the Act that is not
in effect with respect to such drug or class of drugs may
apply.
(d) Use of Advisory Committees; Process for Addressing Drug
Class Effects.--In imposing a requirement under subsection
(c), the Secretary--
(1) may convene a meeting of 1 or more advisory committees
of the Food and Drug Administration in accordance with
paragraph (6) of section 505-1(h) of the Act; and
(2) may use the process described in paragraph (7) of such
section 505-1(h) (relating to addressing drug class effects).
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Michigan (Mr. Dingell) and the gentleman from Texas (Mr. Burgess) each
will control 20 minutes.
The Chair recognizes the gentleman from Michigan.
Mr. DINGELL. Mr. Speaker, I yield myself 5 minutes.
(Mr. DINGELL asked and was given permission to revise and extend his
remarks.)
Mr. DINGELL. I rise to express my strong support for H.R. 2900, the
Food and Drug Administration Amendments Act of 2007.
This is significant legislation, and in the best traditions of the
Committee on Energy and Commerce, it is bipartisan. I want to thank and
commend my Republican colleagues for their assistance in bringing this
bill to the floor, and I want to commend all of the members of the
committee for their hard work, which was done in an extraordinarily
friendly and proper fashion on the legislation.
I rise to inform my colleagues that the bill text before the House
today contains three useful changes in the bill that was reported by
the committee.
There is a section on citizen petitions that is designed to prevent
or minimize delays to the introduction of generic drugs. In addition to
good public policy, it also reduces Federal expenditures and completely
offsets the costs of H.R. 2900 so that the bill we consider today meets
applicable budget pay-as-you-go standards.
The other changes are two clarifications. One, that the Secretary is
not authorized to order changes in the marketing plans or product
sponsors; and two, that PDUFA fees can be used to carry out the bill's
postmarket safety activities under the risk evaluation and mitigation
strategies authorized by the bill, known as REMS.
H.R. 2900 has nine distinct titles. Title I reauthorizes the
Prescription Drug User Fee Act, a very successful piece of legislation.
It significantly boosts resources to have new drugs or biological
products reviewed through a thorough yet timely and careful manner, and
gives greater attention and resources to postmarket drug safety
activities.
Title II reauthorizes the Medical Device User Fee and Modernization
Act, providing increased user fee resources for review of medical
devices. The fee structure is broadened to both stabilize revenue and
decrease the cost of application fees.
Title III is the Pediatric Medical Device Safety and Improvement Act
of 2007. This will foster development of medical devices for use by
children. It fills an important gap in therapies for one of our most
vulnerable and important patient groups who are, after all, the future
of the country. I commend my colleagues, Mr. Markey and Mr. Rogers, for
their fine efforts in this title.
Titles IV and V address the need for drugs that are tested and
labeled for use by children.
Title IV reauthorizes the Pediatric Research Equity Act. This title
will provide FDA permanent authority to test and label drugs for
pediatric patients.
Title V reauthorizes the Best Pharmaceuticals for Children Act,
providing incentive for testing and labeling drugs for pediatric
patients. Together, these two pediatric drug programs provide for the
method to achieve an important common purpose, better therapies for our
children.
I want to recognize the efforts of our dear friend, Representative
Eshoo, on both of these titles.
Titles VI, VII, VIII and IX represent the drug safety component of
the bill.
Title VI establishes the Reagan-Udall Foundation for the Food and
Drug Administration. This will foster public-private partnerships for
the purposes of advancing FDA's mission to modernize product
development, accelerate innovation, and enhance product safety. Our
good friends and colleagues, Mr. Engel and Ms. Giffords, are to be
commended for their work on this title.
Title VII addresses concerns about conflicts of interest amongst
those who serve on the expert advisory panels that play a crucial role
in FDA's work. Title VII establishes a clinical trials registry and
database. This title will expand the amount of information available to
patients, scientists and other stakeholders regarding clinical tests.
Finally, title IX represents a major enhancement of the safety in the
drug program of this country through an active postmarket surveillance
program with the goal of reducing the likelihood of another Vioxx
situation and the reported aftereffects which went unheard. Congressmen
Markey and Waxman made important contributions in this matter.
[[Page H7601]]
I wish also to thank my friend, the committee's ranking member, Mr.
Barton, and the ranking member of the Subcommittee on Health, Mr. Deal.
They worked with us throughout this process and brought forth good
suggestions that make this a better bill. For that I commend them, and
for their hard work I thank them.
Finally, I wish to recognize the outstanding work of the chairman of
the Subcommittee on Health, Mr. Pallone. His firm and steady hand and
hard work brought forth a strong bill out of the subcommittee, and the
House should applaud his extraordinary leadership.
Mr. Speaker, this legislation strikes proper balance between new drug
safety regulations and measures and ensuring consumers have the access
to innovative prescription pharmaceuticals without undue delay.
I urge my colleagues to support H.R. 2900 and ask for a favorable
vote on this legislation.
Mr. Speaker, I reserve the balance of my time, and I ask unanimous
consent that I be permitted to yield the remainder of my time on this
matter to the distinguished gentleman from New Jersey (Mr. Pallone),
the subcommittee chairman, and that he be permitted to control the
time. He will do a splendid job.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Michigan?
There was no objection.
Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
Before he leaves, I want to thank Chairman Dingell for his
willingness to work with the minority side on this. We had a lot of
give-and-take, both at the staff level and certainly at the
subcommittee level and the full committee level, and for that I am
grateful.
I think this is a good piece of legislation, and I think it was
improved by the work of the staff, both on the majority and the
minority side, and I think it was improved by the committee process as
we worked this bill through committee.
I am pleased to support H.R. 2900, and this bill, of course, will
improve the drug and medical device safety approval by the FDA.
Over the past several weeks, members of the Energy and Commerce
Committee, both Republican and Democrat, have come together to hammer
out a bill that will ensure that the American people can rely on the
decisions made by the Food and Drug Administration, that their drugs
are safe, and that regulatory requirements don't overly infringe on
innovation or sound clinical practice of medicine.
H.R. 2900 will achieve several goals, such as providing additional
resources to the Food and Drug Administration to improve premarket drug
and device approval, create new postmarket surveillance authorities,
enhance clinical trial transparency and data mining, and ensure the
adequacy of pediatric studies for drugs and devices.
I would like to thank, again, Chairman Dingell and Chairman Pallone
for working with our Republican staff to improve this legislation
before we convened the markup, and of course during the process of the
markup, again, both at the subcommittee and at the full committee
level.
I'm pleased that we were able to modify the Direct to Consumer
Advertising provision to protect this bill from a constitutional
challenge, Mr. Speaker, and in a manner relying on the existing Food
and Drug Administration regulatory standards.
In regard to pediatric exclusivity, the committee was able to find a
workable standard as opposed to the original proposal that would have
required the Food and Drug Administration accountants to post a lot of
overtime in their jobs.
I'm also pleased with regard to one of my concerns about how the new
postmarket surveillance regime would impact the independent practice of
medicine. I'm pleased that Mr. Waxman, Mr. Pallone and Dingell and
their staffs worked with me to improve the language relating to the
restrictions on distribution and use pursuant to elements of a drug's
risk evaluation and mitigation strategy. Certainly, Mr. Speaker, it was
not the intent, or I did not feel it was the intent of our legislation
to be circumventing clinical judgment of trained and experienced
practitioners. The original language threatened clinical decision
making that is both lawful and based on scientific evidence and sound
medical opinion, but I'm pleased that it has been tempered by the
concerns that I raised to the above-mentioned gentlemen.
One issue that I hope we will continue to work on as this bill moves
toward conference committee relates to the provision on conflicts of
interest.
The Food and Drug Administration advisory panel serves a vital
science function when it comes to the approval of drugs and devices.
{time} 1700
I believe that we should strive to weed out any conflicts of interest
for those that serve on these panels.
But in reality, Mr. Speaker, that is easier said than done. The
standard established in this bill, limiting panels to one waiver for a
conflict of interest, could severely impair the Food and Drug
Administration's advisory panel process, especially for panels convened
to review drugs or devices targeted at very small patient populations,
such as those with very rare diseases. For drugs or devices that would
fall into these categories, it can be extremely difficult to find sound
scientific experts. This irrational standard will only make it harder
to perform that function. Moving forward, I hope we can find and strike
the acceptable balance.
It has already been shown that our collaboration on this endeavor has
produced better legislation. I hope we continue that as the process
moves forward.
Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in strong support of this legislation. I am
extremely proud to say that the bill before us is a product of a
bipartisan effort to ensure that the Food and Drug Administration has
the authority and resources it needs to ensure that American consumers
have timely access to safe and effective prescription drugs and medical
devices.
This bill accomplishes a number of important goals. First and
foremost, the legislation will empower the FDA to protect patients from
potentially harmful prescription drugs. Over the past few years, it has
become clear that consumers have been placed in harm's way due to the
failing of our current drug safety system. The legislation we are
passing today will lay the groundwork for restoring public confidence
in the FDA by giving it the tools it needs to safeguard the public
health.
There are many other significant measures included in the bill before
us, such as the reauthorization of two important user-fee programs that
will provide the FDA with the financial resources it needs to approve
applications for new drugs and devices to be marketed. In addition to
new funding for the pre-market review activities of FDA, this bill
includes a substantial amount of new funding for post-market safety
activities.
The bill will also reauthorize two important programs that will help
encourage drug makers to conduct research into the appropriate use of
prescription drugs in pediatric populations. Similarly, we are
providing new incentives to device manufacturers to develop products
that are specifically designed for use in children. Finally, this bill
establishes the Reagan-Udall Foundation, which will help build public-
private partnerships designed to advance the mission of the FDA.
I would like to thank all the Members who devoted so many hours and
days to developing this bill. Specifically, I would like to thank
Chairman Dingell, Ranking Member Barton, Mr. Deal, Mr. Waxman, Mr.
Markey, Ms. Eshoo, Mr. Rogers and Dr. Burgess, as well, all of them,
for their hard work and devoted staff, as well, because of all the
support that the staff did in their efforts in making this bill
possible.
In closing, I would just like to reiterate that this bill has strong
bipartisan support as well as support from the pharmaceutical and
medical device industries and a number of consumer advocacy
organizations. Few times in the past do I recall that we have
[[Page H7602]]
achieved such a wide-ranging consensus on a bill of this size or
importance. I strongly urge my colleagues to support its passage.
Mr. BURGESS. Mr. Speaker, I am expecting additional speakers, but at
present, I will reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield 4 minutes to the gentleman from
California (Mr. Waxman).
Mr. WAXMAN. Mr. Speaker, I rise in support of this legislation. It is
becoming increasingly clear that FDA needs more of two things; it needs
more resources and more authority. This is particularly true in the
area of post-market drug safety. We are all familiar with the series of
high profile drug safety problems with drugs like Vioxx and Avandia. It
is no secret that FDA's ability to protect the safety of our drugs is
in serious jeopardy. H.R. 2900 makes significant strides in getting FDA
both the authorities and resources to improve its oversight of drug
safety.
I am pleased this bill incorporates many of the provisions in a bill
that I introduced with Representative Markey called the Enhancing Drug
Safety and Innovation Act of 2007. Our bill incorporates many of the
recommendations of a high-profile study by the Institute of Medicine.
For example, it will give the FDA the ability to require post-market
studies and labeling changes, as well as the ability to impose
significant civil monetary penalties to ensure that these things get
done in an appropriate and timely way.
Another section of the bill would establish mandatory clinical trial
registry and results databases. This would bring much-needed
transparency to the clinical trials conducted on our fellow citizens
and will prevent drug and device companies from hiding negative trial
results that cast their products in a negative light.
I do regret that one of the most important recommendations made by
the IOM was stripped from the committee-reported bill: that Congress
give FDA the authority to restrict direct-to-consumer advertising of
new drugs with unknown safety risks. If a new drug is heavily marketed
as a result of direct-to-consumer ads and a serious risk does emerge,
many people will have been unnecessarily exposed to that risk.
Similarly, I regret H.R. 2900 does not contain a provision to
appropriately tailor the period of exclusivity that blockbuster drugs
receive in exchange for conducting pediatric trials under the Best
Pharmaceuticals for Children Act. We all share the goal of ensuring
that our children get the same benefit from FDA approved drugs and all
medical devices, as do adults. But we must make sure that the American
consumers are not paying an unjustified price tag for those tests.
Nevertheless, the bill as a whole makes significant contributions to
the work of the FDA and deserves our support. I do want to emphasize
that the FDA will need a significant influx of resources to do what we
are asking them to do in this bill. Although H.R. 2900 gives FDA the
enhanced ability to dedicate user fee dollars to these activities, it
will be critical for Congress to come forward with additional
appropriated dollars. We simply have got to get FDA the funds it needs
to do their job well.
Every day, Americans rely on FDA to protect them from dangerous
medicines and devices. Today, we have the opportunity to take a
critically important step toward ensuring that FDA can fulfill this
mission.
Mr. Speaker, I encourage Members to support the bill.
Mr. BURGESS. Mr. Speaker, I am pleased to yield 4 minutes to the
gentleman from Pennsylvania (Mr. Murphy), a member of the committee.
Mr. TIM MURPHY of Pennsylvania. Mr. Speaker, I thank the gentleman. I
am here to speak on behalf of this bill and my support for it.
Under the Medical Device User Fee Modernization Act reprocessed or
reused medical devices are brought under the regulation of the FDA.
Now, there is a problem with reusing medical devices sometimes, and
that is these devices were designed for optimal performance and safety
under their intended conditions of use, not necessarily designed for
their ease of cleaning or even secondary use, which make it extremely
difficult to effectively clean and resterilize. Reusing medical devices
can compromise their safety and performance and even destroy some of
these devices. This can also lead to deadly hospital-acquired or
nosocomial infections.
At least half, half, of all cases of nosocomial infections are
associated with medical devices. Let me give some examples of the rates
of infection from these devices: 23 percent of peritoneal dialysis
catheters; 7 percent of pacemakers; 7.2 percent of implantable
cardioverter defibrillators; up to 50 percent of ventricular assist
devices; and 30 percent of bladder catheters, just to name a few.
I would like to thank Chairman Dingell and Ranking Member Barton as
well as Chairman Pallone and Ranking Member Deal for working with me to
include language in the Medical Device User Fee amendments of H.R.
2900, the Food and Drug Administration Act of 2007, for a study on the
causes of these infections, from reprocessed single-use devices; from
handling of sterilized medical devices; from in-hospital sterilization
of medical devices; from health care professionals' practices for
patient examination and treatment; hospital-based policies and
procedures for patient examination and treatment; hospital-based
policies and procedures for infection control and prevention; and
hospital-based practices for handling medical waste and other relevant
hospital practices.
Let me explain why and what this means in terms of real lives and
dollars. A CDC report from a couple of years ago said that learning to
prevent these infections has the potential to save over 90,000 lives
and $50 billion annually, according to the CDC. A more recent report
just came out and said perhaps we are up to even 119,000 lives a year.
Health care providers should work with medical device companies to
provide patients with information if a medical device has been reused.
Patients have the right to know whether or not a medical device
designed for single use has already been used in another patient before
a device is used on them and what can be done and what was done in
terms of sterilization and cleaning that equipment. Otherwise, patients
will be exposed to an unnecessary risk for hospital-acquired infections
and medical device failures.
This study has the potential to save thousands of lives and billions
of dollars. Eliminating infections from medical devices will move us
towards a safer patient-centered health care system that promotes
patient choice, patient safety and patient quality.
We all know that physicians and nurses and hospital personnel are all
dedicated to providing the best health care possible. We also know when
hospitals have worked together to eliminate infections, indeed, that is
what they do. The VA Hospital in Pittsburgh and a number of hospitals
in the Pittsburgh area that I am familiar with and worked with have
indeed brought some post-surgical infection rates down to zero. And
there have been occasional lapses in these throughout the nation where
post-surgical infections or infections associated with medical devices
have been unnecessarily high.
We can prevent these infections. We can save lives. We could save not
only the Federal Government, but other insurance companies, billions of
dollars, and I look forward to passing this bill.
Mr. PALLONE. Mr. Speaker, I would ask unanimous consent that the
gentleman from New York (Mr. Hinchey) be given 5 minutes time in
addition to what we have already allocated to speak in opposition to
the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
Mr. HINCHEY. Mr. Speaker, I very much appreciate the kindness of my
friend and colleague from New Jersey for providing me with this time.
Mr. Speaker, I am a member of the Appropriations Committee and the
subcommittee which has oversight over the Food and Drug Administration,
so over the course of a number of years now, I have been deeply engaged
in this issue.
I am glad that the FDA Amendments Act that we are discussing here
this evening addresses a number of the problems that we have confronted
over the course of the last number of years. These problems include
giving the agency enhanced authority on post-
[[Page H7603]]
market drug safety and developing a strengthened system for oversight
of direct-to-consumer advertising. That is a very good move in the
right direction.
However, I am deeply disappointed that this bill neglects to
sufficiently address a number of other major issues that are
jeopardizing the trustworthiness of the Food and Drug Administration,
the agency that is supposed to represent the gold standard for consumer
protection in America.
First, the FDA Amendments Act reauthorizes the Prescription Drug User
Fee Act through which drug companies provide funding to the FDA for its
drug safety approval and oversight activities. So, in other words, what
we have is the regulated industry paying money to the agency that
judges the worthiness of the industry's products and how they put those
products on the market. To make matters worse, before each
reauthorization of the Prescription Drug User Fee Act, the FDA sits
down with representatives from this industry to negotiate out
performance standards that the agency will achieve in return for those
funds.
In fact, representatives from the FDA met 112 times with
representatives from the big pharmaceutical industry before the agency
sent their recommendations with regard to this bill to Capitol Hill.
Meanwhile, the FDA only met five times with other groups, groups like
consumers, medical professionals and advocates; only five times with
groups like that to hear their perspective on reauthorization of the
Prescription Drug User Fee Act.
The FDA is in bed with the drug companies, and put simply, the FDA
Amendments Act does not sufficiently sever this inappropriate
relationship between the agency and the regulated industry.
Under this bill, the FDA will continue to collect funding from a
regulated industry and will continue to meet industry standards and put
those standards above everyone else's interest.
Second, the FDA Amendment Act does not sufficiently address financial
conflict of interest among members of agency advisory committees.
{time} 1715
These committees exist to provide the agency with unbiased scientific
advice on controversial issues, and such advice can easily be tainted
by these conflicts; and we have seen numerous examples of how it has
been.
Many of my colleagues will remember voting to end such conflicts
during our consideration of the fiscal year 2006 Agricultural
appropriations bill. Since that time, the FDA has come forward with a
new policy of its own that would stop those members with over $5,000
worth of inappropriate financial holdings from even participating on
advisory committees and stop all conflicted members from voting on the
committees regardless of the size of that conflict.
Unfortunately, the FDA Amendment Act does not continue the movement
for change that has been espoused by both the House and now internally
by the FDA. Instead, this legislation would enable the agency to
continue to waive conflicted members on to advisory committees. There
is simply no need for this policy to continue.
Finally, this legislation does nothing to keep the FDA from its
current misinformed policy of preempting State law on drug policy.
The Bush FDA's relentless arguments in favor of preemption robs
consumers of recourse from injury and issues drug companies a free pass
from accountability.
As we have seen from recent flu vaccine crises, revelations of
conflicts of interest, and failures of post-market drugs such as Vioxx,
the FDA is clearly not a perfect agency.
At the same time, drug companies are not sufficiently forthcoming
about side effects related to their products. It is illogical for the
Federal Government to close the door on a method of recourse for
Americans who have been affected by these imperfections. In a world in
which drug companies are not fully clear about the safety of their
drugs, and the FDA is not sufficiently on the side of consumers, the
role of the State courts in protecting Americans is more important than
ever.
I am very disappointed in these provisions, and I think that they all
should be considered carefully in the examination of this legislation.
Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
Number one, my understanding is as we took this bill through the
subcommittee and committee that we accepted legislative language on an
amendment that would provide for a reverse trigger so that if the
gentleman and other appropriators want to provide more money for the
evaluation of new drugs and devices, the actual contribution from the
user fees will decrease. After all, it was a Democratic Congress in
1992 that began the first Prescription Drug User Fee Act, and the
reason for that legislation was because it simply took too long to get
drugs and devices through the regulatory maze. And as a consequence,
practicing physicians such as myself were denied access to life-saving
medications for their patients. So the Democrats in the early 1990s
improved the process by adding the prescription drug user fees, but we
would all be happy with the appropriators if they would step up to the
plate and appropriate the correct amount of money.
Additionally, let me just point out that consumer groups and patient
groups actually are going to be involved in the negotiations for the
next prescription drug user fee authorization. That is language that
was brought to us, I don't remember by which side, but it was an
amendment that was accepted by the full committee. So, Mr. Speaker,
although there are concerns expressed by the gentleman who just spoke,
the reality is many of those things were actually addressed through the
committee and subcommittee process.
I will speak a little further on the conflicts issue as I do my
closing remarks on this bill, but Mr. Waxman so eloquently spoke about
how unfortunate it was we stripped out an Institute of Medicine
recommendation in his previous remarks. The reality is that the
Institute of Medicine recommended that waivers be available for up to
40 percent of FDA panels. Those are the individuals who are the exerts
and who understand what these compounds can and cannot do.
Mr. Speaker, I recognized throughout the committee process that I had
a responsibility as the only member on the committee on either side who
had ever picked up a pen and written a prescription for a patient, who
had ever sat down face to face with a patient and talked about benefits
and potential risks from medications, and who had ever talked to a
patient about the cost of their medication.
I think this legislation was well crafted and well worked up between
both sides as we went through the committee process.
Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
North Carolina (Mr. Butterfield).
Mr. BUTTERFIELD. Mr. Speaker, first let me thank the chairman of the
subcommittee, the gentleman from New Jersey (Mr. Pallone), for yielding
me this time and thank him for his leadership as chairman of the Health
Subcommittee.
Mr. Speaker, the subject of public health remains a top priority for
rural America, including my home district of eastern North Carolina,
the First Congressional District. Health has been an issue that has not
always included the topic of disparities and the lack of access for
minority communities and low-income communities. But under the
leadership of this chairman, I am confident that we are now going in
another direction and we are going to confront head on the issue of
disparities. I want to thank the chairman and the committee for making
the decision to go in that direction.
But, Mr. Speaker, I have come to the floor today to address the
subject of medications that are intended to combat tropical diseases
and their access to the developing world. My desire, Mr. Speaker, is
for the House to further cooperate and work with the other Chamber in
search of a solution to the tropical disease epidemic facing the
developing world. These diseases, such as HIV/AIDS and malaria and
tuberculosis, continue to inflict millions of impoverished people
because of the lack of medicines. In addition to perpetuating extreme
poverty, these diseases also prevent millions of people from working
and participating in family or community life. So as we discuss
[[Page H7604]]
this very important issue, I would like for us to also consider the
issue of tropical disease-combating medications in developing
countries.
Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from
Georgia (Mr. Deal), the ranking member on the Health Subcommittee.
Mr. DEAL of Georgia. Mr. Speaker, I am pleased to support H.R. 2900.
I think this bill plays an important role in ensuring that patients
have timely access to approved, safe, and effective medications and
medical devices. This legislation creates an entirely new post-
marketing drug safety program that will help address some of the
troubling recent drug scares that we have all been aware of.
The Subcommittee on Health in our Energy and Commerce Committee held
numerous hearings on the programs authorized in this bill, and I am
pleased that members of the committee were able to come together to
work out a bipartisan compromise that continues many important programs
of the FDA. For instance, the Prescription Drug and User Fee Amendments
and the Medical Device User Fee Amendments allow the FDA to continue
important programs which provide the agency with resources for the
expeditious review of life-saving drugs and devices.
One important addition in the prescription drug user fee amendments
addresses direct-to-consumer advertisements. I share concern with many
members on the committee about the drug advertisements being presented
to patients, and I am glad the bill takes steps to provide for the
FDA's review of these television ads while at the same time protecting
freedom of speech.
However, our main concern is the FDA's increasing reliance on the
regulated industry to fund its drug review activities, and hope that
future appropriations will take advantage of the amendment I offered at
the full committee to help reduce FDA's dependence on user fees by
replacing them with appropriations. This amendment stated there should
be a dollar-for-dollar reduction in the new user fee for every new
dollar appropriated for post-market safety. The amendment was a step in
the right direction, but I believe more should be done to restore the
balance between user fees and appropriations for drug review.
The bill also continues important programs which encourage the study
of medications in pediatric populations. Meeting the unique medical
needs of children presents special challenges, and H.R. 2900
reauthorizes two programs which have effectively promoted the study of
drugs in children. It also encourages the development of medical
devices for use in pediatric populations.
This legislation also improves FDA drug safety authorities. Recent
incidents have undermined consumer confidence in the FDA's ability to
ensure that the medications they take on a regular basis are safe. H.R.
2900 provides the agency with new tools to better monitor products that
might present greater risk to patients. I believe these reforms will
help maintain the FDA's position as the world leader in protecting
patient safety and access to safe medications.
In conclusion, I think this is a good compromise. Our committee
worked hard on it. Both sides came together in an effort to try to
present this House with a package that I hope will be approved today.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
Massachusetts (Mr. Markey) who had a great deal to do with putting this
bill together.
Mr. MARKEY. I thank the gentleman and congratulate the chairman, the
gentleman from New Jersey (Mr. Pallone), for his enormously successful
work; and Mr. Dingell as well, as well as the key Republicans who
worked on this legislation.
I am pleased that the bill before the House includes language from
the drug safety bill that Mr. Waxman and I introduced in March to
strengthen the FDA's ability to monitor drugs after they have been
approved and create a true post-market safety net system.
As we have seen with drugs such as Vioxx, new side effects and health
risks may only surface after drugs are approved and are used by the
general population. Yet the FDA has not had the authority to mandate
label changes or require further studies to get more information about
these risks once the drugs have been approved. This bill will empower
the FDA with those important new authorities, and it will also
establish a new post-market risk identification and analysis system to
identify harmful side effects and uncover signals of unexpected adverse
events without compromising patient privacy.
I am also pleased that the package includes a strong clinical trials
registry and results database that is consistent with the bill that Mr.
Waxman and I have been championing since 2004 when we learned that some
drug companies were painting distorted pictures of their products by
hiding negative trial results.
The current system, which allows companies to pick and choose which
trials they want to make public, is like allowing students to just pick
the grades they want to bring home. Everyone would have straight A's.
Our bill will establish one central mandatory registry of all
clinical trials with strong enforcement mechanisms to require companies
to make their clinical trials and the result of those trials available
to the public, all of the trials. This is historic because the database
of trial results will ensure that doctors and their patients have
current, complete, and accurate information about all drugs on the
market.
Finally, I want to thank Mr. Rogers from Michigan for working with me
on the pediatric devices bill. It is an important bill that will help
children get the devices that they need. I thank again Mr. Pallone, Mr.
Dingell, and all the others who worked on this bill.
Mr. BURGESS. Mr. Speaker, may I inquire as to the time remaining.
The SPEAKER pro tempore. The gentleman from Texas has 6\1/2\ minutes
and the gentleman from New Jersey has 5 minutes.
Mr. BURGESS. Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield 1\1/2\ minutes to the gentlewoman
from Arizona (Ms. Giffords).
Ms. GIFFORDS. Mr. Speaker, I rise today in support of the Safe and
Effective Drug Development Act, which was adopted as an amendment to
H.R. 2900 in committee. I would like to thank Mr. Dingell, Mr. Engel,
Mr. Hall, and Mrs. Blackburn for their work on this legislation.
An op-ed in today's Washington Post by Dr. Lichtenberg from Columbia
University identified medical innovation as the key factor contributing
to the increase in life expectancy here in the United States over the
last 15 years. I think we would all agree that living longer is a very
good thing.
However, in 2004, the FDA identified 76 specific problems that have
caused a critical slow down in medical innovation. This legislation
formalizes public-private partnerships between the FDA, nonprofits, and
universities. These partnerships help solve the problems that stand
between new biomedical discoveries and how quickly and safely these
discoveries are translated to consumers.
I want to thank the gentleman for allowing me to speak and thank all
of those staff and of course the committee members who worked so hard
on this legislation.
{time} 1730
Mr. BURGESS. Mr. Speaker, I yield myself the balance of my time.
Again, Mr. Speaker, I want to point out, Mr. Waxman in his remarks
discussed the Institute of Medicine study, and in fact, when we talked
about the issue that's still the unresolved issue of the conflict-of-
interest waivers, the Institute of Medicine itself recommended that the
Food and Drug Administration advisory panels, those panels that are
convened to advise the Food and Drug Administration on the acceptance
or rejection of new drugs and new devices, that that panel could be
comprised of up to 40 percent of individuals for whom a conflict-of-
interest waiver was obtained.
The current legislation has language in it that will restrict that
waiver to one such individual, and as we've already heard from the
other side, even that one conflict waiver is too much for some people
to tolerate. But the reality, if the FDA is allowed to issue only one
waiver per panel meeting, they will find themselves seeking the
guidance of fellows that have just
[[Page H7605]]
passed their boards and are beginning their practice of medicine. The
drafters of the code of Federal regulations did not intend that only
the most recent graduates of a fellowship program or residency program
be considered the so-called expert.
At present, medical societies find restrictions on the FDA panel
nominees increasingly difficult due to a number of criteria that must
be met in addition to considerations for the conflicts of interest.
The Food and Drug Administration panels must have geographic, ethnic
and gender diversity. We've already heard discussion from the other
side of how they're concerned about aggravating ethnic disparities.
Here's another place where we could perhaps reverse that trend.
For clinical representation, panel members on those Food and Drug
Administration advisory panels, panel members should be practicing
physicians and, in fact, should have practiced for many years. They
should have accumulated a body of experience. They should have
knowledge of the conduct of clinical trials. They should have knowledge
of statistics.
They should have intricate knowledge of the specific anatomy if
they're on a device panel. They may need to know about the
biomechanical forces imposed on the anatomy if a device is implanted or
the cellular biology to determine wear and tear on the devices and
knowledge of the American Society for Testing and Materials or
international standards organizations. Members may also need to know
about the packaging and the effects of radiation on many of the device
components.
For some panels, such as on March 29 of this year, the Cellular
Tissue and Gene Therapies Advisory Committee meeting to provide
guidance to the Food and Drug Administration on biological license
applications, such as the medicine that might be used for treatment of
men with asymptomatic metastatic hormone refractory prostate cancer;
these panels must have a specific knowledge base that far exceeds that
of a practicing physician.
And indeed, I heard from other individuals where the universe of
patients may be quite small for patients who have a certain type of
brain malignancy. The universe of patients may be only 1,000 or 1,500.
The people that develop the drugs are of necessity going to be people
who have been employed by those industries that were developing the
drugs. Why exclude them from the panel? Why craft a law where the only
people in the room are, by law, going to be people who have no
knowledge of the intricacy of the specific disease being treated or no
knowledge of the surgical procedures required to implant those medical
devices? Why restrict ourselves in that way?
We just heard eloquent testimony from the gentlewoman from Arizona
talking about the devices and those medications and treatments that are
just over the horizon to us right now that we can't imagine, we can't
envision. Why restrict those Food and Drug Administration advisory
panels to one conflict-of-interest waiver?
Mr. Speaker, I will submit being in public service can be expensive,
it can be time-consuming, and it can be embarrassing. Why make it
harder for these individuals to participate in these panels? Frankly, I
do not understand that. I hope we will continue to work on that process
as we get to the conference activity on this bill. I'm looking forward
to those discussions.
But in reality, the bill that is before us today is, in fact, a good
bill. The committee staff on both sides did great work as far as
getting language that would be acceptable to both sides, and we were
not an easy audience to please on many occasions through the debate on
that bill.
But Mr. Speaker, I do rise in support of the bill. I do think it is
worthy of the House's consideration and passage.
Mr. Speaker, I yield back the balance of my time.
General Leave
Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days to revise and extend their remarks and
include extraneous material on the bill under consideration.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
Mr. PALLONE. Mr. Speaker, before we proceed to the vote on H.R. 2900,
I yield myself time to acknowledge the months of work that Members have
done leading to this bill coming before the House today. It truly was a
bipartisan effort, and everyone worked so hard.
I also wish to take a moment to recognize the efforts of the staff
who worked long hours in ensuring we produced a quality piece of
legislation. In particular, I thank Warren Burke and Ellen Sutherland,
professional staff with the Office of Legislative Counsel, for their
outstanding service.
I also want to thank the staff of the Committee on Energy and
Commerce. I'm not going to mention the Republicans, not because they
didn't do as much work, because they certainly did, but I don't
remember all their names. I don't want to eliminate anybody.
As far as the Democratic staff is concerned, I do want to
specifically mention John Ford, Pete Goodloe, Jack Maniko, Melissa
Sidman, Jessica McNiece, Bob Clark and Virgil Miller. And from Mr.
Waxman's staff, because Mr. Waxman and Mr. Markey played a major role
in this bill and Mr. Waxman's staff in particular, Karen Nelson, Rachel
Sher and Stephen Cha. And again, everyone worked very hard on this.
I think it is really remarkable that we were able to achieve a
consensus and bring this up today, particularly under suspension.
Mr. HALL of New York. Mr. Speaker, this evening, the House of
Representatives considered H.R. 2900, The Food and Drug Administration
Amendments of 2007, which, among other things reauthorized the FDA
through 2012. I voted for this bill because I believe it's vital for
our national interests that the FDA be authorized, and I am aware that
the current authorization is due to expire very shortly. That said, I
cast this vote with great reservations. The current funding of the FDA
is too dependent on the companies that the Agency is supposed to be
regulating. There is an inherent and unacceptable conflict of interest
in this arrangement. To be a truly effective regulator, the FDA must be
a completely independent entity, with no outside relationships. Only
then can the American people be absolutely certain that the agency is
always acting with their best interests in mind.
It is my hope that during conference with the Senate some greater
protections can be added to this legislation to ensure that it is an
independent entity in which we can place our full and complete trust.
Mr. VAN HOLLEN. Mr. Speaker, I rise in support of H.R. 2900, the Food
and Drug Administration Amendments Act of 2007.
I am proud that the headquarters of the Food and Drug Administration
(FDA) is located in the Congressional District that I represent. I
commend the hard working employees at FDA for their service and
dedication to our country. However, serious gaps have been exposed in
FDA's ability to protect the American public due to recent outbreaks of
food-borne illnesses as well as high-profile post-market safety
problems. It has become clear that FDA lacks the adequate resources to
fulfill its vast and vital public health mission.
In light of these events, we need to ensure that the FDA has the
necessary tools and resources to protect the American public from
unsafe products. H.R. 2900 takes a good first step in providing FDA
with those resources in reauthorizing the Prescription Drug User Fee
Act (PDUFA). Since its inception in 1992, PDUFA has helped enable FDA
to approve more than 1,100 new medicines and reduce review times for
innovative drugs and biologics, providing patients and doctors with
earlier access to breakthrough treatments. Congress must reauthorize
the prescription drug and medical device user fee programs in a timely
manner to avoid any workforce disruptions at FDA. Without this bill,
FDA will not have adequate resources to fulfill its mission. In
addition, the innovation and development of new therapies will be
hampered if PDUFA is not renewed--the FDA approval process will be too
long for new potential treatments. With this reauthorization, the FDA
will be permitted to collect a total of $393 million in prescription
drug user fees per year through FY 2012.
H.R. 2900 also expands the FDA's ability to monitor the safety of
drugs after they have been approved and marketed. In addition, the
legislation creates a public database for ongoing and completed
clinical trials. It is important to have all the information about any
drug during the trial stage be disclosed to the public so that doctors
can make sound medical decisions and provide their patients with the
best possible care.
I am also pleased that the legislation includes a provision that
expands on the successful Critical Path Initiative. FDA established
[[Page H7606]]
the Critical Path Initiative in 2004 to improve the efficiency and
safety of drug and medical product development. This provision
authorizes the FDA to enter into Critical Path Public-Private
Partnerships with universities and non-profit organizations to
modernize the process to develop prescription drugs and other medical
products. These collaborations will help the FDA move drugs and medical
devices through the approval process in a quicker, safer and more
reliable manner at a lower cost.
Mr. Speaker, the Food and Drug Administration Amendments Act is only
one important step in providing FDA with the necessary tools and
resources to do its job. Congress must also significantly increase
federal appropriations to FDA so that the agency is able to fulfill its
most basic responsibilities. Such an increase will not only make foods,
drugs and devices safer, but it will also lead to a stronger, more
effective FDA that can restore public confidence, speed innovation and
ensure that America remains competitive in foreign markets.
I believe H.R. 2900 will help ensure the timely access to safe and
effective prescription drugs and medical devices as well as improve the
integrity of the drug approval process at FDA. I urge my colleagues to
support H.R. 2900.
Mr. GENE GREEN of Texas. Mr. Speaker, I rise in strong support of
H.R. 2900, legislation to reauthorize important user fee programs at
the Food and Drug Administration and enact critical drug safety reforms
at the agency.
This legislation is the result of years of hard work by the Energy
and Commerce Committee and particularly the Oversight and
Investigations Subcommittee and the Health Subcommittee. I am proud to
serve on both of these subcommittees. The Oversight and Investigations
Subcommittee has worked on a bi-partisan basis to investigate the drug
safety concerns brought to light by scandals associated with drugs such
as Vioxx, Ketek and Selective Serotonin Reuptake Inhibitors, or SSRIs,
which are typically used to treat depression. These investigations
uncovered significant safety lapses at the FDA and shed a bright light
on the FDA's bias toward drug approval with too little attention paid
to post-market safety concerns.
The FDA Amendments Act of 2007 makes important changes at the FDA to
place a greater emphasis on post-market surveillance within the agency.
Specifically, this legislation would establish a Risk, Evaluation, and
Mitigation Strategy whereby drugs approved by the agency are monitored
throughout their life-cycle for adverse events or other signs of safety
concerns. A critical aspect of this strategy is the additional
authority this bill gives the Secretary of HHS to mandate that drug
manufacturers conduct post-market studies.
Under this bill, the additional post-market activities extend to the
user fee programs that help fund the drug approval process.
Specifically, this bill directs drug manufacturers utilizing the FDA's
drug approval process to dedicate an additional $225 million over five
years for post-market surveillance activities at the FDA. This
additional funding represents an important investment by the
pharmaceutical industry in the FDA's postmarket safety activities,
while also ensuring that pre-market user fees are adequate to bring
potentially life-saving medicines to market in a reasonable time.
This legislation also reauthorizes the Medical Device User Fee Act,
as well as the Best Pharmaceuticals For Children Act and the Pediatric
Research Equity Act. The unanimous support of the committee for this
bill is a testament to the open process and bi-partisan nature in which
the committee members and staff on both sides of the aisle conducted
these negotiations.
I would like to thank our Chairman, Mr. Dingell, and our Health
Subcommittee Chairman, Mr. Pallone, for their work on this important
legislation, and encourage my colleagues to support this important
bill. These necessary changes at the FDA will go a long way toward
restoring the American public's confidence in the agency and its
ability to ensure the safety of the nation's drug supply.
Ms. HOOLEY. Mr. Speaker, I am particularly pleased that H.R. 2900
includes a provision I authored and worked on with my colleague Mr.
Doyle from Pennsylvania that will require the FDA to establish a unique
device identification (UDI) system for medical devices.
Currently, most medical devices cannot be tracked or identified in
any systemic fashion. A UDI will enable the FDA to better pinpoint
devices associated with adverse events and look for patterns across
event reports. A more sophisticated reporting system will thus
strengthen FDA's post-market surveillance capabilities.
A UDI system will not only provide FDA with the tools to discover
warning signs of a defective device earlier, thus potentially savings
lives, but will also improve the agency's ability to promptly respond
to device recalls. I believe our current system for notifying patients
in the event of a recall is deficient. When defective medical devices
are recalled, the absence of a standard identification system hinders
the FDA's ability to notify patients. These UDI provisions take an
important step toward improving the ability of the FDA, device
manufacturers, and physicians to quickly and effectively communicate
risk information to patients.
Ms. ESHOO. Mr. Speaker, I rise in full support of H.R. 2900, the Food
and Drug Administration Amendments Act of 2007. An extraordinary amount
of time was put into negotiating this bill and the fact that it's
coming to the floor without contention is a testament to the leadership
of our Committee and Subcommittee Chairmen, Ranking Member, and
Majority and Minority staffs.
The bill is important for ensuring the safety and efficacy of
pharmaceuticals and medical devices available to the American public.
It includes necessary funding for vital FDA functions, such as drug and
device review and approval, and also enhances post-market surveillance
activities for these products.
I want to focus my remarks on the sections of the bill that renew the
Pediatric Research Equity Act (PREA), and the Best Pharmaceuticals for
Children Act (BPCA). I championed the original enactments of these
successful programs which have helped to increase the number of drugs
tested and labeled for use in children, and I'm proud these programs
will be renewed and further improved under this bill.
According to the American Academy of Pediatrics, only about 25% of
drugs administered to children have been appropriately tested for use
in kids. Pediatricians often have to prescribe drugs for ``off-label''
use, because the drug has not been studied in appropriate FDA-approved
pediatric clinical trials. Children have specific medical needs that
have to be considered when drugs are used. Children have died or
suffered serious side effects after taking drugs that were shown safe
for use in adults but had different results in children.
I've worked with stakeholders on all sides of this issue to update
BPCA and PREA to increase the amount and quality of pediatric
information available to doctors, parents, and researchers. I've also
enhanced labeling and post-market safety requirements. The bill also
makes permanent the FDA's authority to require pediatric studies of
drugs, which is consistent with its permanent authority to require
studies of adult formulations. Together, these changes will help to
generate important new information about the safety and efficacy of
drugs prescribed to children.
A coalition of children's groups has endorsed H.R. 2900. The bill was
unanimously passed out of the Energy and Commerce Committee before the
July 4th Recess and I urge my colleagues to support it.
In closing I want to thank the staff members who have worked
exceedingly hard to bring this bill to the Floor today: John Ford,
Bobby Clark, Pete Goodloe and Jack Maniko of the Energy and Commerce
Committee Majority staff, Ryan Long and John Little of the Minority
staff, and Jennifer Nieto from my office.
I'm proud to be an original cosponsor of H.R. 2900 and I urge my
colleagues to vote for it.
Mr. PALLONE. Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from New Jersey (Mr. Pallone) that the House suspend the
rules and pass the bill, H.R. 2900, as amended.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. PALLONE. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the
Chair's prior announcement, further proceedings on this question will
be postponed.
____________________