[Congressional Record Volume 153, Number 139 (Wednesday, September 19, 2007)]
[House]
[Pages H10551-H10599]
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. 3580) 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.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 3580
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; finding.
[[Page H10552]]
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.
Sec. 107. Effective date.
Sec. 108. Savings clause.
Sec. 109. Technical amendment; conforming amendment.
TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
Sec. 201. Short title; references in title; finding.
Subtitle A--Fees Related to Medical Devices
Sec. 211. Definitions.
Sec. 212. Authority to assess and use device fees.
Sec. 213. Reauthorization; reporting requirements.
Sec. 214. Savings clause.
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.
Sec. 230. Report by the Food and Drug Administration regarding labeling
information on the relationship between the use of indoor
tanning devices and development of skin cancer or other
skin damage.
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 surveillance.
TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007
Sec. 401. Short title.
Sec. 402. Reauthorization of Pediatric Research Equity Act.
Sec. 403. Establishment of internal committee.
Sec. 404. 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.
Sec. 503. Training of pediatric pharmacologists.
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. Expanded clinical trial registry data bank.
TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS
Subtitle A--Postmarket Studies and Surveillance
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. Active postmarket risk identification and analysis.
Sec. 906. Statement for inclusion in direct-to-consumer advertisements
of drugs.
Sec. 907. No effect on veterinary medicine.
Sec. 908. Authorization of appropriations.
Sec. 909. Effective date and applicability.
Subtitle B--Other Provisions to Ensure Drug Safety and Surveillance
Sec. 911. Clinical trial guidance for antibiotic drugs.
Sec. 912. Prohibition against food to which drugs or biological
products have been added.
Sec. 913. Assuring pharmaceutical safety.
Sec. 914. Citizen petitions and petitions for stay of agency action.
Sec. 915. Postmarket drug safety information for patients and
providers.
Sec. 916. Action package for approval.
Sec. 917. Risk communication.
Sec. 918. Referral to advisory committee.
Sec. 919. Response to the institute of medicine.
Sec. 920. Database for authorized generic drugs.
Sec. 921. Adverse drug reaction reports and postmarket safety.
TITLE X--FOOD SAFETY
Sec. 1001. Findings.
Sec. 1002. Ensuring the safety of pet food.
Sec. 1003. Ensuring efficient and effective communications during a
recall.
Sec. 1004. State and Federal Cooperation.
Sec. 1005. Reportable Food Registry.
Sec. 1006. Enhanced aquaculture and seafood inspection.
Sec. 1007. Consultation regarding genetically engineered seafood
products.
Sec. 1008. Sense of Congress.
Sec. 1009. Annual report to Congress.
Sec. 1010. Publication of annual reports.
Sec. 1011. Rule of construction.
TITLE XI--OTHER PROVISIONS
Subtitle A--In General
Sec. 1101. Policy on the review and clearance of scientific articles
published by FDA employees.
Sec. 1102. Priority review to encourage treatments for tropical
diseases.
Sec. 1103. Improving genetic test safety and quality.
Sec. 1104. NIH Technical amendments.
Sec. 1105. Severability clause.
Subtitle B--Antibiotic Access and Innovation
Sec. 1111. Identification of clinically susceptible concentrations of
antimicrobials.
Sec. 1112. Orphan antibiotic drugs.
Sec. 1113. Exclusivity of certain drugs containing single enantiomers.
Sec. 1114. Report.
TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.
(a) Short Title.--This title may be cited as the
``Prescription Drug User Fee Amendments of 2007''.
(b) References in Title.--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.).
(c) Finding.--The Congress finds that the fees authorized
by the amendments made in this title will be dedicated toward
expediting the drug development process and the process for
the review of human drug applications, including postmarket
drug safety activities, as set forth in the goals identified
for purposes of part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act, in the letters from the
Secretary of Health and Human Services to the Chairman of the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Chairman of the Committee on Energy and
Commerce of the House of Representatives, as set forth in the
Congressional Record.
SEC. 102. DEFINITIONS.
Section 735 (21 U.S.C. 379g) is amended--
(1) in the matter before paragraph (1), by striking ``For
purposes of this subchapter'' and inserting ``For purposes of
this part'';
(2) in paragraph (1)--
(A) in subparagraph (A), by striking ``505(b)(1),'' and
inserting ``505(b), or'';
(B) by striking subparagraph (B);
(C) by redesignating subparagraph (C) as subparagraph (B);
and
(D) in the matter following subparagraph (B), as so
redesignated, by striking ``subparagraph (C)'' and inserting
``subparagraph (B)'';
(3) 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)'';
(4) in paragraph (4), by inserting before the period at the
end the following: ``(such as capsules, tablets, or
lyophilized products before reconstitution)'';
(5) 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
[[Page H10553]]
clinical trials and labeling changes) and section 505(p)
(relating to risk evaluation and mitigation strategies).
``(v) Carrying out section 505(k)(5) (relating to adverse
event reports and postmarket safety activities).'';
(6) 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'';
(7) by redesignating paragraph (9) as paragraph (11); and
(8) 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 paragraph (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 be applied 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)(I) for fiscal year 2008, $25,000,000;
``(II) for fiscal year 2009, $35,000,000;
``(III) for fiscal year 2010, $45,000,000;
``(IV) for fiscal year 2011, $55,000,000; and
``(V) for fiscal year 2012, $65,000,000.''.
(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 by
subparagraph (D)), 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.--Paragraph (4) of section 736(c)
(21 U.S.C. 379h(c)), as redesignated by paragraph (3)(A), is
amended to read as follows:
``(4) Final year adjustment.--
``(A) Increase in fees.--For fiscal year 2012, the
Secretary may, in addition to adjustments under this
paragraph and paragraphs (1), (2), and (3), further increase
the fee revenues and fees established in subsection (b) if
such an adjustment is necessary to provide for not more than
3 months of operating reserves of carryover user fees for the
process for the review of human drug applications for the
first 3 months of fiscal year 2013. If such an adjustment is
necessary, the rationale for the amount of the increase
[[Page H10554]]
shall be contained in the annual notice establishing fee
revenues and fees for fiscal year 2012. If the Secretary has
carryover balances for such process in excess of 3 months of
such operating reserves, the adjustment under this
subparagraph shall not be made.
``(B) Decrease in fees.--
``(i) In general.--For fiscal year 2012, the Secretary may,
in addition to adjustments under this paragraph and
paragraphs (1), (2), and (3), decrease the fee revenues and
fees established in subsection (b) by the amount determined
in clause (ii), if, for fiscal year 2009 or 2010--
``(I) the amount of the total appropriations 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 appropriations for the Food and Drug
Administration for fiscal year 2008 (excluding the amount of
fees appropriated for such fiscal year), adjusted as provided
under paragraph (1); and
``(II) the amount of the total appropriations expended for
the process for the review of human drug applications 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 expended for the process for the
review of human drug applications at the Food and Drug
Administration for fiscal year 2008 (excluding the amount of
fees appropriated for such fiscal year), adjusted as provided
under paragraph (1).
``(ii) Amount of decrease.--The amount determined in this
clause is the lesser of--
``(I) the amount equal to the sum of the amounts that, for
each of fiscal years 2009 and 2010, is the lesser of--
``(aa) the excess amount described in clause (i)(II) for
such fiscal year; or
``(bb) the amount specified in subsection (b)(4)(B)(ii) for
such fiscal year; or
``(II) $65,000,000.
``(iii) Limitations.--
``(I) Fiscal year condition.--In making the determination
under clause (ii), an amount described in subclause (I) of
such clause for fiscal year 2009 or 2010 shall be taken into
account only if subclauses (I) and (II) of clause (i) apply
to such fiscal year.
``(II) Relation to subparagraph (A).--The Secretary shall
limit any decrease under this paragraph if such a limitation
is necessary to provide for the 3 months of operating
reserves described in subparagraph (A).''.
(5) Limit.--Paragraph (5) of section 736(c) (21 U.S.C.
379h(c)), as redesignated by paragraph (3)(A), is amended 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.--
``(1) Exemption.--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 establishment fees under this
section, if the drug meets all of the following conditions:
``(A) The drug meets the public health requirements
contained in this Act as such requirements are applied to
requests for waivers for product and establishment fees.
``(B) The drug is owned or licensed and is marketed by a
company that had less than $50,000,000 in gross worldwide
revenue during the previous year.
``(2) Evidence of qualification.--An exemption under
paragraph (1) applies with respect to a drug only if the
applicant involved submits a certification that its gross
annual revenues did not exceed $50,000,000 for the preceding
12 months before the exemption was requested.''.
(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)''.
(h) Technical Amendment.--
(1) Amendment.--Section 736(g)(1) (21 U.S.C. 379h(g)(1)) is
amended by striking the first sentence and inserting the
following: ``Fees authorized under subsection (a) 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.''.
(2) Effective date.--Paragraph (1) shall take effect as if
included in section 504 of the Prescription Drug User Fee
Amendments of 2002 (Public Law 107-188; 116 Stat. 687).
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
dissemination 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 to be submitted to the
Secretary prior to initial public dissemination is not
subject to a fee under subparagraph (A) unless the sponsor
designates the submission as a submission for 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
advisory review in the next fiscal year. Notwithstanding the
preceding sentence, for fiscal year 2008, the Secretary shall
publish such a notice in the Federal Register not later than
30 days after the date of the enactment of the Food and Drug
Administration Amendments Act of 2007.
``(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 to be
submitted for advisory review, subject to subparagraph
(F)(i). Notwithstanding the preceding sentence, the advisory
review fee for any DTC advertisement that is intended to be
submitted for advisory review during fiscal year 2008 shall
be due not later than 120 days after the date of the
enactment of the Food and Drug Administration Amendments of
2007 or an earlier date as specified by the Secretary.
``(ii) Effect of submission.--Notification of the Secretary
under subparagraph (C) of the number of DTC advertisements a
person intends to submit for 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. Notwithstanding the preceding
sentence, the commitment shall be a legally binding
commitment by that person to pay the annual advisory review
fee for that number of submissions for fiscal year 2008 by
the date specified in clause (i).
``(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 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) not later than November 1 of such fiscal
year (or, in the case of such a notification submitted with
respect to fiscal year 2008, not later than 150 days after
the date of the enactment of the Food and Drug Administration
Amendments Act of 2007 or an earlier date specified by the
Secretary), the fees
[[Page H10555]]
shall be regarded as late and an increase in the amount of
fees applies in accordance with this clause, notwithstanding
any other provision of this section. For such person, all
advisory review fees for such fiscal year shall be due and
payable 20 days before any direct-to-consumer advertisement
is submitted to the Secretary for advisory review, and each
such fee shall 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 advertisements for advisory
review in a fiscal year that exceeds the number identified by
the person under subparagraph (C), 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 advertisement, the advisory
review fee shall be due and payable 20 days before the
advertisement is submitted to the Secretary, and the fee
shall 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 subsections
(d)(4) and (f), fees paid under this section 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--
``(i) October 1 of the first fiscal year in which the
person is required to pay an advisory review fee under
paragraph (1); or
``(ii) for fiscal year 2008, 120 days after the date of the
enactment of the Food and Drug Administration Amendments Act
of 2007 or an earlier date specified by the Secretary.
``(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
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)(E)(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 advisory review.
``(D) Late payment.--
``(i) In general.--Notwithstanding subparagraph (B), and
subject to clause (ii), an operating reserve fee shall be
regarded as late if the person required to pay the fee has
not paid the complete operating reserve fee by--
``(I) for fiscal year 2008, 150 days after the date of the
enactment of the Food and Drug Administration Amendments Act
of 2007 or an earlier date specified by the Secretary; or
``(II) in any subsequent year, November 1.
``(ii) Complete payment.--The complete operating reserve
fee shall be due and payable 20 days before any DTC
advertisement is submitted by such person to the Secretary
for advisory review.
``(iii) Amount.--Notwithstanding any other provision of
this section, an operating reserve fee that is regarded as
late under this subparagraph shall be equal to 150 percent of
the operating reserve fee that otherwise would have applied
pursuant to subsection (d).
``(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 shall
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
dissemination. 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 (or, with respect to fiscal year 2008, not later than 90
days after the date of the enactment of the Food and Drug
Administration Amendments Act of 2007), 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 under subsection
(a)(1)(F)(i).
``(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
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 after
the end of fiscal year 2012, or if the program under this
section ends early pursuant to subsection (f), the
[[Page H10556]]
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 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 the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, 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
terminate, and the Secretary shall notify all participants,
retain any money from the unused advisory review fees and the
operating reserves needed to terminate the program, and
refund the remainder of the unused fees and operating
reserves. To the extent required to terminate the program,
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)
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 section:
``(1) The term `advisory review' means reviewing and
providing advisory comments on DTC advertisements regarding
compliance of a proposed advertisement with the requirements
of this Act prior to its initial public dissemination.
``(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 `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 dissemination 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 dissemination.
``(9) 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) terminating the program under this section pursuant
to subsection (f)(2) if that becomes necessary.
``(10) 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.
``(11) 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.
Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et
seq.), as amended by section 104, is further amended by
inserting after section 736A the following:
``SEC. 736B. 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 this part, 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 101(c) of the Food and Drug Administration Amendments
Act of 2007 during such fiscal year and the future plans of
the Food and Drug Administration for meeting the goals. The
report for a fiscal year shall include information on all
previous cohorts for which the Secretary has not given a
complete response on all human drug applications and
supplements in the cohort.
``(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 this part, 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) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to
the public on the Internet Web site of the Food and Drug
Administration.
``(d) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to the Congress 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;
[[Page H10557]]
``(D) health care professionals;
``(E) representatives of patient and consumer advocacy
groups; and
``(F) the regulated industry.
``(2) Prior public input.--Prior to beginning negotiations
with the regulated industry on the reauthorization of this
part, the Secretary shall--
``(A) publish a notice in the Federal Register requesting
public input on the reauthorization;
``(B) hold a public meeting at which the public may present
its views on the reauthorization, including specific
suggestions for changes to the goals referred to in
subsection (a);
``(C) provide a period of 30 days after the public meeting
to obtain written comments from the public suggesting changes
to this part; and
``(D) publish the comments on the Food and Drug
Administration's Internet Web site.
``(3) Periodic consultation.--Not less frequently than once
every month during negotiations with the regulated industry,
the Secretary shall hold discussions with representatives of
patient and consumer advocacy groups to continue discussions
of their views on the reauthorization and their suggestions
for changes to this part as expressed under paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, 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.
``(5) Transmittal of recommendations.--Not later than
January 15, 2012, the Secretary shall transmit to the
Congress the revised recommendations under paragraph (4), 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.
``(6) Minutes of negotiation meetings.--
``(A) Public availability.--Before presenting the
recommendations developed under paragraphs (1) through (5) to
the Congress, the Secretary shall make publicly available, on
the public Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted under this
subsection between the Food and Drug Administration and the
regulated industry.
``(B) Content.--The minutes described under subparagraph
(A) shall summarize any substantive proposal made by any
party to the negotiations as well as significant
controversies or differences of opinion during the
negotiations and their resolution.''.
SEC. 106. SUNSET DATES.
(a) Authorization.--The amendments made by sections 102,
103, and 104 cease to be effective October 1, 2012.
(b) Reporting Requirements.--The amendment made by section
105 ceases to be effective January 31, 2013.
SEC. 107. EFFECTIVE DATE.
The amendments made by this title shall take effect on
October 1, 2007, or the date of the enactment of this Act,
whichever is later, except that fees under part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act shall be assessed for all human drug
applications received on or after October 1, 2007, regardless
of the date of the enactment of this Act.
SEC. 108. SAVINGS CLAUSE.
Notwithstanding section 509 of the Prescription Drug User
Fee Amendments of 2002 (21 U.S.C. 379g note), and
notwithstanding the amendments made by this title, part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act, as in effect on the day before the date of the
enactment of this title, shall continue to be in effect with
respect to human drug applications and supplements (as
defined in such part as of such day) that on or after October
1, 2002, but before October 1, 2007, were accepted by the
Food and Drug Administration for filing with respect to
assessing and collecting any fee required by such part for a
fiscal year prior to fiscal year 2008.
SEC. 109. TECHNICAL AMENDMENT; CONFORMING AMENDMENT.
(a) Section 739 (21 U.S.C. 379j-11) is amended in the
matter preceding paragraph (1) by striking ``subchapter'' and
inserting ``part''.
(b) Paragraph (11) of section 739 (21 U.S.C. 379j-11) is
amended by striking ``735(9)'' and inserting ``735(11)''.
TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Medical
Device User Fee Amendments of 2007''.
(b) References in Title.--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.).
(c) Finding.--The Congress finds that the fees authorized
under the amendments made by this title will be dedicated
toward expediting the process for the review of device
applications and for assuring the safety and effectiveness of
devices, as set forth in the goals identified for purposes of
part 3 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act in the letters from the Secretary of
Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Chairman of the Committee on Energy and Commerce of the House
of Representatives, as set forth in the Congressional Record.
Subtitle A--Fees Related to Medical Devices
SEC. 211. DEFINITIONS.
Section 737 is amended--
(1) in the matter preceding paragraph (1), by striking
``For purposes of this subchapter'' and inserting ``For
purposes of this part'';
(2) by redesignating paragraphs (5), (6), (7), and (8) as
paragraphs (8), (9), (10), and (12), respectively;
(3) by inserting after paragraph (4) the following:
``(5) The term `30-day notice' means a notice under section
515(d)(6) that is limited to a request to make modifications
to manufacturing procedures or methods of manufacture
affecting the safety and effectiveness of the device.
``(6) 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.
``(7) The term `annual fee', for periodic reporting
concerning a class III device, means the annual fee
associated with periodic reports required by a premarket
application approval order.'';
(4) in paragraph (10), 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 (10), as so amended, the
following:
``(11) The term `person' includes an affiliate thereof.'';
and
(6) by inserting after paragraph (12), as so redesignated,
the following:
``(13) The term `establishment subject to a registration
fee' 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, 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, within the meaning of section 201(ll)(2)(A), performs
additional processing and manufacturing operations on a
single-use device that has previously been used on a patient.
``(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.--Section 738(a) (21 U.S.C. 379j(a)) is
amended--
(A) in paragraph (1), by striking ``Beginning on the date
of the enactment of the Medical Device User Fee and
Modernization Act of 2002'' and inserting ``Beginning in
fiscal year 2008''; and
(B) by amending the designation and heading of paragraph
(2) 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) 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--
(i) by striking ``1.42 percent'' and inserting ``1.84
percent''; and
(ii) by striking ``, subject to any adjustment under
subsection (e)(2)(C)(ii)''; 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,
an annual fee 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:
[[Page H10558]]
``(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)(4) 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--
(A) in clause (iii), by striking the last two sentences;
and
(B) 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 an application submitted under
section 515(c)(4) that is withdrawn before a second portion
is submitted and before a first action on the first portion.
``(v) Later withdrawn modular applications.--If an
application submitted under section 515(c)(4) is withdrawn
after a second or subsequent portion 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
portions submitted.
``(vi) Sole discretion to refund.--The Secretary shall have
sole discretion to refund a fee or portion of the fee under
clause (iii) or (v). A determination by the Secretary
concerning a refund under clause (iii) or (v) shall not be
reviewable.''.
(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 a registration fee 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), (e), and (h) the fees under subsection (a) shall be
based on the following fee amounts:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal Year
Fee Type Year 2008 Year 2009 Year 2010 Year 2011 2012
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................. $185,000 $200,725 $217,787 $236,298 $256,384
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 fewer than 12,250.
The percentage increase shall be the percentage by which the
estimate of establishments submitting fees in fiscal year
2009 is fewer 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
or 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 or 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, 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)(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:
[[Page H10559]]
``(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
or 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 or 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 a
registration fee 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) by striking paragraph (1) and inserting the following:
``(1) Performance goals; termination of program.--With
respect to the amount that, under the salaries and expenses
account of the Food and Drug Administration, is appropriated
for a fiscal year for devices and radiological products, fees
may not be assessed under subsection (a) for the fiscal year,
and the Secretary is not expected to meet any performance
goals identified for the fiscal year, if--
``(A) the amount so appropriated for the fiscal year,
excluding the amount of fees appropriated for the fiscal
year, is more than 1 percent less than $205,720,000
multiplied by the adjustment factor applicable to such fiscal
year; or
``(B) fees were not assessed under subsection (a) 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 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. REAUTHORIZATION; REPORTING REQUIREMENTS.
Part 3 of subchapter C of chapter VII is amended by
inserting after section 738 the following:
``SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS.
``(a) Reports.--
``(1) Performance report.--For fiscal years 2008 through
2012, not later than 120 days after the end of each fiscal
year during which fees are collected under this part, the
Secretary shall prepare and 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 concerning the progress of the Food
and Drug Administration in achieving the goals identified in
the letters described in section 201(c) of the Food and Drug
Administration Amendments Act of 2007 during such fiscal year
and the future plans of the Food and Drug Administration for
meeting the goals. The report for a fiscal year shall include
information on all previous cohorts for which the Secretary
has not given a complete response on all device premarket
applications and reports, supplements, and premarket
notifications in the cohort.
``(2) Fiscal report.--For fiscal years 2008 through 2012,
not later than 120 days after the end of each fiscal year
during which fees are collected under this part, the
Secretary shall prepare and 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 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 for which the report is made.
``(3) Public availability.--The Secretary shall make the
reports required under paragraphs (1) and (2) available to
the public on the Internet Web site of the Food and Drug
Administration.
``(b) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to Congress with respect to the goals, and plans for
meeting the goals, for the process for the review of device
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) Prior public input.--Prior to beginning negotiations
with the regulated industry on the reauthorization of this
part, the Secretary shall--
``(A) publish a notice in the Federal Register requesting
public input on the reauthorization;
``(B) hold a public meeting at which the public may present
its views on the reauthorization, including specific
suggestions for changes to the goals referred to in
subsection (a)(1);
``(C) provide a period of 30 days after the public meeting
to obtain written comments from the public suggesting changes
to this part; and
``(D) publish the comments on the Food and Drug
Administration's Internet Web site.
``(3) Periodic consultation.--Not less frequently than once
every month during negotiations with the regulated industry,
the Secretary shall hold discussions with representatives of
patient and consumer advocacy groups to continue discussions
of their views on the reauthorization and their suggestions
for changes to this part as expressed under paragraph (2).
``(4) Public review of recommendations.--After negotiations
with the regulated industry, 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.
``(5) Transmittal of recommendations.--Not later than
January 15, 2012, the Secretary shall transmit to Congress
the revised recommendations under paragraph (4), a summary of
the views and comments received under such paragraph, and any
[[Page H10560]]
changes made to the recommendations in response to such views
and comments.
``(6) Minutes of negotiation meetings.--
``(A) Public availability.--Before presenting the
recommendations developed under paragraphs (1) through (5) to
the Congress, the Secretary shall make publicly available, on
the public Web site of the Food and Drug Administration,
minutes of all negotiation meetings conducted under this
subsection between the Food and Drug Administration and the
regulated industry.
``(B) Content.--The minutes described under subparagraph
(A) shall summarize any substantive proposal made by any
party to the negotiations as well as significant
controversies or differences of opinion during the
negotiations and their resolution.''.
SEC. 214. SAVINGS CLAUSE.
Notwithstanding section 107 of the Medical Device User Fee
and Modernization Act of 2002 (Public Law 107-250), and
notwithstanding the amendments made by this subtitle, part 3
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the
day before the date of the enactment of this subtitle, shall
continue to be in effect with respect to premarket
applications, premarket reports, premarket notification
submissions, and supplements (as defined in such part as of
such day) that on or after October 1, 2002, but before
October 1, 2007, were accepted by the Food and Drug
Administration for filing with respect to assessing and
collecting any fee required by such part for a fiscal year
prior to fiscal year 2008.
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--
(1) $7,100,000 for fiscal year 2008;
(2) $7,455,000 for fiscal year 2009;
(3) $7,827,750 for fiscal year 2010;
(4) $8,219,138 for fiscal year 2011; and
(5) $8,630,094 for fiscal year 2012.
SEC. 216. EFFECTIVE DATE.
The amendments made by this subtitle shall take effect on
October 1, 2007, or the date of the enactment of this Act,
whichever is later, except that fees under part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act shall be assessed for all premarket
applications, premarket reports, supplements, 30-day notices,
and premarket notification submissions received on or after
October 1, 2007, regardless of the date of the enactment of
this Act.
SEC. 217. SUNSET CLAUSE.
The amendments made by this subtitle cease to be effective
October 1, 2012, except that section 738A of the Federal
Food, Drug, and Cosmetic Act (regarding annual performance
and financial 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 ``(b) On or before'' and inserting ``(b)(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) 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.''.
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 of
the Federal Food, Drug, and Cosmetic Act, the study under
subsection (a) shall consider the Secretary of Health and
Human Services's evaluation of the respective intended uses
and technologies of such devices, including the effectiveness
of such Secretary's comparative assessment of technological
characteristics such as device 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.
(a) In General.--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 label of devices to bear a
unique identifier, unless the Secretary requires an
alternative placement or provides an exception for a
particular device or type of device. The unique identifier
shall adequately identify the device through distribution and
use, and may include information on the lot or serial
number.''.
(b) Conforming Amendment.--Section 303 (21 U.S.C. 333) is
amended--
(1) by redesignating the subsection that follows subsection
(e) as subsection (f); and
(2) in paragraph (1)(B)(ii) of subsection (f), as so
redesignated, by striking ``519(f)'' and inserting
``519(g)''.
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), unless the Secretary grants an exemption or
variance from, or an alternative to, a requirement under such
regulations pursuant to section 803.19 of such part, 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 which the Secretary has, by notice
published in the Federal Register or letter to the person who
is the manufacturer or importer of the device, indicated
should be subject to such part 803 in order to protect the
public health;
``(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; or
``(iii) shall, if the device is imported into the United
States and for which part 803 of title 21, Code of Federal
Regulations (or successor regulations) requires an importer
to submit a report to the manufacturer, be submitted by the
importer to the manufacturer in accordance with part 803 of
title 21, Code of Federal Regulations (or successor
regulations)''.
SEC. 228. INSPECTIONS BY ACCREDITED PERSONS.
Section 704(g) (21 U.S.C. 374(g)) is amended--
[[Page H10561]]
(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 operator 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 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.
SEC. 230. REPORT BY THE FOOD AND DRUG ADMINISTRATION
REGARDING LABELING INFORMATION ON THE
RELATIONSHIP BETWEEN THE USE OF INDOOR TANNING
DEVICES AND DEVELOPMENT OF SKIN CANCER OR OTHER
SKIN DAMAGE.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), acting
through the Commissioner of Food and Drugs, shall determine--
[[Page H10562]]
(1) whether the labeling requirements for indoor tanning
devices, including the positioning requirements, provide
sufficient information to consumers regarding the risks that
the use of such devices pose for the development of
irreversible damage to the eyes and skin, including skin
cancer; and
(2)(A) whether modifying the warning label required on
tanning beds to read, ``Ultraviolet radiation can cause skin
cancer'', or any other additional warning, would communicate
the risks of indoor tanning more effectively; or
(B) whether there is no warning that would be capable of
adequately communicating such risks.
(b) Consumer Testing.--In making the determinations under
subsection (a), the Secretary shall conduct appropriate
consumer testing to determine consumer understanding of label
warnings.
(c) Report.--Not later than 1 year after the date of the
enactment of this Act, the Secretary shall submit to the
Congress a report that provides the determinations under
subsection (a). In addition, the Secretary shall include in
the report the measures being implemented by the Secretary to
significantly reduce the risks associated with indoor tanning
devices.
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 the 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
the 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, 2012.
``(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) The Secretary, acting through the Office of Pediatric
Therapeutics and the Center for Devices and Radiological
Health, 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--
(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
[[Page H10563]]
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 purchasing pediatric devices, based on a
representative sampling 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, which shall include an evaluation of the number
of pediatric medical devices--
(A) that have been or are being studied in children; and
(B) that have been submitted to the Food and Drug
Administration for approval, clearance, or review under such
section 520(m) (as amended by this Act) and any regulatory
actions taken.
(c) Guidance.--Not later than 180 days after the date of
the 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) Contact Point for Available Funding.--Section 402(b) of
the Public Health Service Act (42 U.S.C. 282(b)) is amended--
(1) in paragraph (21), by striking ``and'' after the
semicolon at the end;
(2) in paragraph (22), by striking the period at the end
and inserting ``; and''; and
(3) by inserting after paragraph (22) the following:
``(23) shall designate a contact point or office to help
innovators and physicians identify sources of funding
available for pediatric medical device development.''.
(b) Plan for Pediatric Medical Device Research.--
(1) In general.--Not later than 180 days after the date of
the enactment of this Act, the Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
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 Secretary of Health and Human
Services 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 the 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 facilitate the
development, production, and distribution of pediatric
medical devices by--
(1) encouraging innovation and connecting qualified
individuals with pediatric device ideas with potential
manufacturers;
(2) mentoring and managing pediatric device projects
through the development process, including product
identification, prototype design, device development, and
marketing;
(3) connecting innovators and physicians to existing
Federal and non-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) assessing the scientific and medical merit of proposed
pediatric device projects; and
(5) providing assistance and advice as needed on business
development, personnel training, prototype development,
postmarket needs, and other activities consistent with the
purposes of this section.
(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 402(b)(23) of the Public Health Service Act, as added
by section 304(a) of this Act; 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.
(3) Effectiveness and outcomes.--Each consortium that
receives a grant or contract under this section shall
annually report to the Secretary of Health and Human Services
on the status of pediatric device development, production,
and distribution that has been facilitated by the consortium.
(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 SURVEILLANCE.
Section 522 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360l) is amended--
(1) by amending the section heading and designation to read
as follows:
``SEC. 522. POSTMARKET SURVEILLANCE.'';
(2) by striking subsection (a) and inserting the following:
``(a) Postmarket Surveillance.--
``(1) In general.--
``(A) Conduct.--The Secretary may by order require a
manufacturer to conduct postmarket surveillance for any
device of the manufacturer that is a class II or class III
device--
``(i) the failure of which would be reasonably likely to
have serious adverse health consequences;
``(ii) that is expected to have significant use in
pediatric populations; or
``(iii) that is intended to be--
``(I) implanted in the human body for more than 1 year; or
``(II) a life-sustaining or life-supporting device used
outside a device user facility.
``(B) Condition.--The Secretary may order a postmarket
surveillance under subparagraph (A) as a condition to
approval or clearance of a device described in subparagraph
(A)(ii).
``(2) Rule of construction.--The provisions of paragraph
(1) shall have no effect on authorities otherwise provided
under the Act or regulations issued under this Act.''; and
(3) in subsection (b)--
(A) by striking ``(b) Surveillance Approval.--Each'' and
inserting the following:
``(b) Surveillance Approval.--
``(1) In general.--Each'';
[[Page H10564]]
(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 surveillance 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, because
of noncompliance with such order or condition, be deemed in
violation of section 301(q)(1)(C), adulterated under section
501(f)(1), misbranded under section 502(t)(3), or in
violation of, as applicable, section 510(k) or section 515,
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''.
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 the 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
any pertinent reviews for 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 Web site 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 Web site 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.--After providing notice in the form of a
letter (that, for a drug approved under section 505,
references a declined written request under section 505A for
a labeled indication which written request is not referred
under section 505A(n)(1)(A) to the Foundation of the National
Institutes of Health for the pediatric studies), 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
[[Page H10565]]
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 promptly be made available to
the public in an easily accessible manner, including through
posting on the Web site 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.
``(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.
``(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) 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, Assessments, Deferrals,
and Waivers.--
``(1) Review.--Beginning not later than 30 days after the
date of the enactment of the Pediatric Research Equity Act of
2007, the Secretary shall utilize the internal committee
established under section 505C 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.
``(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) or (5), which members of the committee participated in
such activity.
``(4) Review of pediatric plans, assessments, deferrals,
and waivers.--Consultation on pediatric plans and assessments
by the committee referred to in paragraph (1) 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 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,
including with respect to whether such a supplement, when
submitted, shall be considered for priority review.
``(5) Retrospective review of pediatric assessments,
deferrals, and waivers.--Not later than 1 year after the date
of the enactment of the Pediatric Research Equity Act of
2007, the committee referred to in paragraph (1) shall
conduct a retrospective review and analysis of a
representative sample of assessments submitted and deferrals
and waivers approved under this section since the 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.--The
Secretary, in consultation with the committee referred to in
paragraph (1), shall track and make available to the public
in an easily accessible manner, including through posting on
the Web site 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);
``(I) an annual summary of information submitted pursuant
to subsection (a)(3)(B); and
``(J) the number of times the committee referred to in
paragraph (1) made a recommendation to the Secretary under
paragraph (4) regarding priority review, the number of times
the Secretary followed or did not follow such a
recommendation, and, if not followed, the reasons why such a
recommendation was not followed.
``(g) Labeling Changes.--
``(1) Dispute resolution.--
``(A) Request for labeling change and failure to agree.--
If, on or after the date of the 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 or supplement to make any labeling changes
that the Commissioner determines to be appropriate.
``(D) Misbranding.--If the sponsor of the application or
supplement, 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 or supplement 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,
[[Page H10566]]
delay, or serve as the basis to stay the other course of
action.
``(2) Other labeling changes.--If, on or after the date of
the 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 210 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 Web site of the Food and Drug
Administration.
``(2) Dissemination of information regarding labeling
changes.--Beginning on the date of the 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 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 the
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 such reports, the Director of
such Office shall provide for the review of such 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.
``(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 or
precursor regulations 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.
``(m) Integration With Other Pediatric Studies.--The
authority under this section shall remain in effect so long
as an application subject to this section may be accepted for
filing by the Secretary on or before the date specified in
section 505A(q).''.
(b) Applicability.--
(1) In general.--Notwithstanding subsection (h) of section
505B of the Federal Food, Drug and Cosmetic Act, as in effect
on the day before the date of the enactment of this Act, a
pending assessment, including a deferred assessment, required
under such section 505B shall be deemed to have been required
under section 505B of the Federal Food, Drug and Cosmetic Act
as in effect on or after the date of the enactment of this
Act.
(2) Certain assessments and waiver requests.--An assessment
pending on or after the date that is 1 year prior to the date
of the enactment of this Act shall be subject to the tracking
and disclosure requirements established under such section
505B, as in effect on or after such date of enactment, except
that any such assessments submitted or waivers of such
assessments requested before such date of enactment shall not
be subject to subsections (a)(4)(C), (b)(2)(C), (f)(6)(F),
and (h) of such section 505B.
SEC. 403. ESTABLISHMENT OF INTERNAL COMMITTEE.
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. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC
PLANS, ASSESSMENTS, DEFERRALS, AND WAIVERS.
``The Secretary shall establish an internal committee
within the Food and Drug Administration to carry out the
activities as described in sections 505A(f) and 505B(f). 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, such as expertise in
child and adolescent psychiatry, and other individuals
designated by the Secretary.''.
SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.
Not later than January 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;
(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)--
[[Page H10567]]
``(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 made under subsection (d)(3) is made later than
9 months 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 timeframe, and the reports thereof
are submitted and accepted in accordance with subsection
(d)(3)--
``(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 made under subsection (d)(3) is made later than
9 months 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.--The Secretary shall utilize the
internal review committee established under section 505C 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).
``(2) Review of written requests.--The committee referred
to in paragraph (1) shall review all written requests issued
pursuant to this section prior to being issued.
``(3) Review of pediatric studies.--The committee referred
to in paragraph (1) may review studies conducted pursuant to
this section to make a recommendation to the Secretary
whether to accept or reject such reports under subsection
(d)(3).
[[Page H10568]]
``(4) 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.
``(5) Documentation of committee action.--For each drug,
the committee referred to in paragraph (1) shall document,
for each activity described in paragraph (2) or (3), which
members of the committee participated in such activity.
``(6) Tracking pediatric studies and labeling changes.--The
Secretary, in consultation with the committee referred to in
paragraph (1), shall track and make available to the public,
in an easily accessible manner, including through posting on
the Web site 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 drug 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.
``(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,
except that such drug may not receive any additional such
period under subsection (c)(1)(B); 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.--
``(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, including whether such study results are
inconclusive, in pediatric populations or subpopulations, 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 210 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 of a drug have not been completed under
subsection (d) and if the Secretary, through the committee
established under section 505C, 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 carry out the following:
``(A) For a drug for which a listed patent has not expired,
make a determination regarding whether an assessment shall be
required to be submitted under section 505B(b). Prior to
making such a determination, the Secretary may not take more
than 30 days to certify whether the Foundation for the
National Institutes of Health has sufficient funding at the
time of such certification to initiate and fund all of the
studies in the written request in their entirety within the
timeframes specified within the written request. Only if the
Secretary makes such certification in the affirmative, the
Secretary
[[Page H10569]]
shall refer all pediatric studies in the written request to
the Foundation for the National Institutes of Health for the
conduct of such studies, and such Foundation shall fund such
studies. If no certification has been made at the end of the
30-day period, or if the Secretary certifies that funds are
not sufficient to initiate and fund all the studies in their
entirety, the Secretary shall consider whether assessments
shall be required under section 505B(b) for such drug.
``(B) For a drug that has no listed patents or has 1 or
more listed patents that have expired, the Secretary shall
refer the drug for inclusion on the list established under
section 409I of the Public Health Service Act for the conduct
of studies.
``(2) Public notice.--The Secretary shall give the public
notice of a decision under paragraph (1)(A) not to require an
assessment under section 505B and the basis for such
decision.
``(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.
``(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 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;
``(4) review and assess the pediatric studies of biological
products as required under subsections (a) and (b) of section
505B; and
``(5) 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) Applicability.--
(A) In general.--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) issued
on or after the date of the enactment of this Act.
(B) Certain written requests.--A written request issued
under section 505A of the Federal Food, Drug, and Cosmetic
Act, as in effect on the day before the date of the enactment
of this Act, which has been accepted and for which no
determination under subsection (d)(2) of such section has
been made before such date of enactment, shall be subject to
such section 505A, except that such written requests shall be
subject to subsections (d)(2)(A)(ii), (e)(1) and (2), (f),
(i)(2)(A), (j), (k)(1), ( l)(1), and (n) of section 505A of
the Federal Food, Drug, and Cosmetic Act, as in effect on or
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).
[[Page H10570]]
``(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 Web site 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 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) 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)' '' and inserting ``and studies for which the
Secretary issues a certification in the affirmative under
section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic
Act''.
(d) 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.''.
(e) 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 505B(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''.
(f) 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.
SEC. 503. TRAINING OF PEDIATRIC PHARMACOLOGISTS.
(a) Investment in Tomorrow's Pediatric Researchers.--
Section 452G(2) of the Public Health Service Act (42 U.S.C.
285g-10(2)) is amended by adding before the period at the end
the following: ``, including pediatric pharmacological
research''.
(b) Pediatric Research Loan Repayment Program.--Section
487F(a)(1) of the Public Health Service Act (42 U.S.C. 288-
6(a)(1)) is amended by inserting ``including pediatric
pharmacological research,'' after ``pediatric research,''.
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
[[Page H10571]]
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 14 individuals, of which 9 shall be from a list of
candidates to be provided by the National Academy of Sciences
and 5 shall be from lists of candidates provided by patient
and consumer advocacy groups, professional scientific and
medical societies, and industry trade organizations. 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 patient or consumer
advocacy organizations;
``(IV) 1 shall be a representative of health care
providers; and
``(V) 4 shall be at-large members with expertise or
experience relevant to the purpose of the Foundation.
``(ii) Requirements.--
``(I) Expertise.--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.
``(II) Federal employees.--No employee of the Federal
Government shall be appointed as a member of the Board under
this subparagraph or under paragraph (3)(B).
``(D) Initial meeting.--
``(i) In general.--Not later than 30 days after the date of
the enactment of this subchapter, 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)--
``(I) the terms of service of the Director of the Centers
for Disease Control and Prevention and of the Director of the
Agency for Healthcare Research and Quality as ex officio
members of the Board shall terminate; and
``(II) the Commissioner and the Director of the National
Institutes of Health shall continue to serve as ex officio
members of the Board, but shall be nonvoting members.
``(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.
[[Page H10572]]
``(f) Nonprofit Status.--In carrying out subsection (b),
the Board shall establish such policies and bylaws under
subsection (d), and the Executive Director shall carry out
such activities under subsection (g), as may be necessary to
ensure that the Foundation maintains status as an
organization that--
``(1) is described in subsection (c)(3) of section 501 of
the Internal Revenue Code of 1986; and
``(2) is, under subsection (a) of such section, exempt from
taxation.
``(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.
``(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
and section 566 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 the 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;
``(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; and
``(6) develop postmarket safety performance measures that
are as measurable and rigorous as the ones already developed
for premarket review.''.
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, may enter into collaborative
agreements, to be known as Critical Path Public-
[[Page H10573]]
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, manufacturing,
and translational therapeutics, 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 a consortium of such institutions; 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, which
may include graduate training programs in areas relevant to
priorities of the Critical Path Initiative.
``(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 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 as defined in
section 351 of the Public Health Service Act, 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.--The Secretary shall--
``(i) 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;
``(ii) seek input from professional medical and scientific
societies to determine the most effective informational and
recruitment activities; and
``(iii) 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)(2) of this
section for service on the committee at a meeting of the
committee.
``(c) Disclosures; Prohibitions on Participation;
Waivers.--
``(1) Disclosure of financial interest.--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) Prohibitions and waivers on participation.--
``(A) In general.--Except as provided under subparagraph
(B), a member of an advisory committee may not participate
with respect to a particular matter considered in an advisory
committee meeting 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.
``(B) Waiver.--If the Secretary determines it necessary to
afford the advisory committee essential expertise, the
Secretary may grant a waiver of the prohibition in
subparagraph (A) to permit a member described in such
subparagraph to--
``(i) participate as a non-voting member with respect to a
particular matter considered in a committee meeting; or
``(ii) participate as a voting member with respect to a
particular matter considered in a committee meeting.
``(C) Limitation on waivers and other exceptions.--
``(i) Definition.--For purposes of this subparagraph, the
term `exception' means each of the following with respect to
members of advisory committees:
``(I) A waiver under section 505(n)(4) (as in effect on the
day before the date of the enactment of the Food and Drug
Administration Amendments Act of 2007).
``(II) A written determination under section 208(b) of
title 18, United States Code.
``(III) A written certification under section 208(b)(3) of
such title.
``(ii) Determination of total number of members slots and
member exceptions during fiscal year 2007.--The Secretary
shall determine--
``(I)(aa) for each meeting held by any advisory committee
during fiscal year 2007, the number of members who
participated in the meeting; and
``(bb) the sum of the respective numbers determined under
item (aa) (referred to in this subparagraph as the ``total
number of 2007 meeting slots''); and
``(II)(aa) for each meeting held by any advisory committee
during fiscal year 2007, the number of members who received
an exception for the meeting; and
``(bb) the sum of the respective numbers determined under
item (aa) (referred to in this subparagraph as the ``total
number of 2007 meeting exceptions'').
``(iii) Determination of percentage regarding exceptions
during fiscal year 2007.--The Secretary shall determine the
percentage constituted by--
``(I) the total number of 2007 meeting exceptions; divided
by
``(II) the total number of 2007 meeting slots.
``(iv) Limitation for fiscal years 2008 through 2012.--The
number of exceptions at the Food and Drug Administration for
members of advisory committees for a fiscal year may not
exceed the following:
``(I) For fiscal year 2008, 95 percent of the percentage
determined under clause (iii) (referred to in this clause as
the ``base percentage'').
``(II) For fiscal year 2009, 90 percent of the base
percentage.
[[Page H10574]]
``(III) For fiscal year 2010, 85 percent of the base
percentage.
``(IV) For fiscal year 2011, 80 percent of the base
percentage.
``(V) For fiscal year 2012, 75 percent of the base
percentage.
``(v) Allocation of exceptions.--The exceptions authorized
under clause (iv) for a fiscal year may be allocated within
the centers or other organizational units of the Food and
Drug Administration as determined appropriate by the
Secretary.
``(3) 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 (except as provided in subparagraph (B)) not 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 (2)(B) 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 Web site
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 (2)(B) 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 Web site 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)(3) (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)(3) 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)(3) 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 Amendments.--Section 505(n) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended
by--
(1) striking paragraph (4); and
(2) 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. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.
(a) In General.--Section 402 of the Public Health Service
Act (42 U.S.C. 282) is amended by--
(1) redesignating subsections (j) and (k) as subsections
(k) and (l), respectively; and
(2) inserting after subsection (i) the following:
``(j) Expanded Clinical Trial Registry Data Bank.--
``(1) Definitions; requirement.--
``(A) Definitions.--In this subsection:
``(i) Applicable clinical trial.--The term `applicable
clinical trial' means an applicable device clinical trial or
an applicable drug clinical trial.
``(ii) Applicable device clinical trial.--The term
`applicable device clinical trial' means--
``(I) a prospective clinical study of health outcomes
comparing an intervention with a device subject to section
510(k), 515, or 520(m) of the Federal Food, Drug, and
Cosmetic Act against a control in human subjects (other than
a small clinical trial to determine the feasibility of a
device, or a clinical trial to test prototype devices where
the primary outcome measure relates to feasibility and not to
health outcomes); and
``(II) a pediatric postmarket surveillance as required
under section 522 of the Federal Food, Drug, and Cosmetic
Act.
``(iii) Applicable drug clinical trial.--
``(I) In general.--The term `applicable drug clinical
trial' means a controlled clinical investigation, other than
a phase I clinical investigation, of a drug subject to
section 505 of the Federal Food, Drug, and Cosmetic Act or to
section 351 of this Act.
``(II) Clinical investigation.--For purposes of subclause
(I), the term `clinical investigation' has the meaning given
that term in section 312.3 of title 21, Code of Federal
Regulations (or any successor regulation).
``(III) Phase i.--For purposes of subclause (I), the term
`phase I' has the meaning given that term in section 312.21
of title 21, Code of Federal Regulations (or any successor
regulation).
``(iv) Clinical trial information.--The term `clinical
trial information' means, with respect to an applicable
clinical trial, those data elements that the responsible
party is required to submit under paragraph (2) or under
paragraph (3).
``(v) Completion date.--The term `completion date' means,
with respect to an applicable clinical trial, the date that
the final subject was examined or received an intervention
for the purposes of final collection of data for the primary
outcome, whether the clinical trial concluded according to
the prespecified protocol or was terminated.
``(vi) Device.--The term `device' means a device as defined
in section 201(h) of the Federal Food, Drug, and Cosmetic
Act.
``(vii) 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.
``(viii) Ongoing.--The term `ongoing' means, with respect
to a clinical trial of a drug or a device and to a date,
that--
``(I) 1 or more patients is enrolled in the clinical trial;
and
``(II) the date is before the completion date of the
clinical trial.
``(ix) Responsible party.--The term `responsible party',
with respect to a clinical trial of a drug or device, means--
``(I) the sponsor of the clinical trial (as defined in
section 50.3 of title 21, Code of Federal Regulations (or any
successor regulation)); or
``(II) the principal investigator of such clinical trial if
so designated by a sponsor, grantee, contractor, or awardee,
so long as the principal investigator is responsible for
conducting the trial, has access to and control over the data
from the clinical trial, has the right to publish the results
of the trial, and has the ability to meet all of the
requirements under this subsection for the submission of
clinical trial information.
``(B) Requirement.--The Secretary shall develop a mechanism
by which the responsible party for each applicable clinical
trial shall submit the identity and contact information of
such responsible party to the Secretary at the time of
submission of clinical trial information under paragraph (2).
``(2) Expansion of clinical trial registry data bank with
respect to clinical trial information.--
``(A) In general.--
``(i) Expansion of data bank.--To enhance patient
enrollment and provide a mechanism to track subsequent
progress of clinical trials, the Secretary, acting through
the Director of NIH, shall expand, in accordance with this
subsection, the clinical trials registry of the data bank
described under subsection (i)(1) (referred to in this
subsection as the `registry data bank'). The Director of NIH
shall ensure that the registry data bank is made publicly
available through the Internet.
``(ii) Content.--The clinical trial information required to
be submitted under this paragraph for an applicable clinical
trial shall include--
``(I) descriptive information, including--
``(aa) a brief title, intended for the lay public;
``(bb) a brief summary, intended for the lay public;
``(cc) the primary purpose;
``(dd) the study design;
``(ee) for an applicable drug clinical trial, the study
phase;
``(ff) study type;
``(gg) the primary disease or condition being studied, or
the focus of the study;
``(hh) the intervention name and intervention type;
``(ii) the study start date;
``(jj) the expected completion date;
``(kk) the target number of subjects; and
``(ll) outcomes, including primary and secondary outcome
measures;
[[Page H10575]]
``(II) recruitment information, including--
``(aa) eligibility criteria;
``(bb) gender;
``(cc) age limits;
``(dd) whether the trial accepts healthy volunteers;
``(ee) overall recruitment status;
``(ff) individual site status; and
``(gg) in the case of an applicable drug clinical trial, 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, specify whether or not there is expanded access to
the drug 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;
``(III) location and contact information, including--
``(aa) the name of the sponsor;
``(bb) the responsible party, by official title; and
``(cc) the facility name and facility contact information
(including the city, State, and zip code for each clinical
trial location, or a toll-free number through which such
location information may be accessed); and
``(IV) administrative data (which the Secretary may make
publicly available as necessary), including--
``(aa) the unique protocol identification number;
``(bb) other protocol identification numbers, if any; and
``(cc) the Food and Drug Administration IND/IDE protocol
number and the record verification date.
``(iii) Modifications.--The Secretary may by regulation
modify the requirements for clinical trial information under
this paragraph, if the Secretary provides a rationale for why
such a modification improves and does not reduce such
clinical trial information.
``(B) Format and structure.--
``(i) Searchable categories.--The Director of NIH shall
ensure that the public may, in addition to keyword searching,
search the entries in the registry data bank by 1 or more of
the following criteria:
``(I) The disease or condition being studied in the
clinical trial, using Medical Subject Headers (MeSH)
descriptors.
``(II) The name of the intervention, including any drug or
device being studied in the clinical trial.
``(III) The location of the clinical trial.
``(IV) The age group studied in the clinical trial,
including pediatric subpopulations.
``(V) The study phase of the clinical trial.
``(VI) The sponsor of the clinical trial, which may be the
National Institutes of Health or another Federal agency, a
private industry source, or a university or other
organization.
``(VII) The recruitment status of the clinical trial.
``(VIII) The National Clinical Trial number or other study
identification for the clinical trial.
``(ii) Additional searchable category.--Not later than 18
months after the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, the Director of NIH
shall ensure that the public may search the entries of the
registry data bank by the safety issue, if any, being studied
in the clinical trial as a primary or secondary outcome.
``(iii) Other elements.--The Director of NIH shall also
ensure that the public may search the entries of the registry
data bank by such other elements as the Director deems
necessary on an ongoing basis.
``(iv) Format.--The Director of the NIH shall ensure that
the registry data bank is easily used by the public, and that
entries are easily compared.
``(C) Data submission.--The responsible party for an
applicable clinical trial, including an applicable drug
clinical trial for a serious or life-threatening disease or
condition, that is initiated after, or is ongoing on the date
that is 90 days after, the date of the enactment of the Food
and Drug Administration Amendments Act of 2007, shall submit
to the Director of NIH for inclusion in the registry data
bank the clinical trial information described in of
subparagraph (A)(ii) not later than the later of--
``(i) 90 days after such date of enactment;
``(ii) 21 days after the first patient is enrolled in such
clinical trial; or
``(iii) in the case of a clinical trial that is not for a
serious or life-threatening disease or condition and that is
ongoing on such date of enactment, 1 year after such date of
enactment.
``(D) Posting of data.--
``(i) Applicable drug clinical trial.--The Director of NIH
shall ensure that clinical trial information for an
applicable drug clinical trial submitted in accordance with
this paragraph is posted in the registry data bank not later
than 30 days after such submission.
``(ii) Applicable device clinical trial.--The Director of
NIH shall ensure that clinical trial information for an
applicable device clinical trial submitted in accordance with
this paragraph is posted publicly in the registry data bank--
``(I) not earlier than the date of clearance under section
510(k) of the Federal Food, Drug, and Cosmetic Act, or
approval under section 515 or 520(m) of such Act, as
applicable, for a device that was not previously cleared or
approved, and not later than 30 days after such date; or
``(II) for a device that was previously cleared or
approved, not later than 30 days after the clinical trial
information under paragraph (3)(C) is required to be posted
by the Secretary.
``(3) Expansion of registry data bank to include results of
clinical trials.--
``(A) Linking registry data bank to existing results.--
``(i) In general.--Beginning not later than 90 days after
the date of the enactment of the Food and Drug Administration
Amendments Act of 2007, for those clinical trials that form
the primary basis of an efficacy claim or are conducted after
the drug involved is approved or after the device involved is
cleared or approved, the Secretary shall ensure that the
registry data bank includes links to results information as
described in clause (ii) for such clinical trial--
``(I) not earlier than 30 days after the date of the
approval of the drug involved or clearance or approval of the
device involved; or
``(II) not later than 30 days after the results information
described in clause (ii) becomes publicly available.
``(ii) Required information.--
``(I) FDA information.--The Secretary shall ensure that the
registry data bank includes links to the following
information:
``(aa) If an advisory committee considered at a meeting an
applicable clinical trial, any posted Food and Drug
Administration summary document regarding such applicable
clinical trial.
``(bb) If an applicable drug clinical trial was conducted
under section 505A or 505B of the Federal Food, Drug, and
Cosmetic Act, a link to the posted Food and Drug
Administration assessment of the results of such trial.
``(cc) Food and Drug Administration public health
advisories regarding the drug or device that is the subject
of the applicable clinical trial, if any.
``(dd) For an applicable drug clinical trial, the Food and
Drug Administration action package for approval document
required under section 505(l)(2) of the Federal Food, Drug,
and Cosmetic Act.
``(ee) For an applicable device clinical trial, in the case
of a premarket application under section 515 of the Federal
Food, Drug, and Cosmetic Act, the detailed summary of
information respecting the safety and effectiveness of the
device required under section 520(h)(1) of such Act, or, in
the case of a report under section 510(k) of such Act, the
section 510(k) summary of the safety and effectiveness data
required under section 807.95(d) of title 21, Code of Federal
Regulations (or any successor regulation).
``(II) NIH information.--The Secretary shall ensure that
the registry data bank includes links to the following
information:
``(aa) Medline citations to any publications focused on the
results of an applicable clinical trial.
``(bb) The entry for the drug that is the subject of an
applicable drug clinical trial in the National Library of
Medicine database of structured product labels, if available.
``(iii) Results for existing data bank entries.--The
Secretary may include the links described in clause (ii) for
data bank entries for clinical trials submitted to the data
bank prior to enactment of the Food and Drug Administration
Amendments Act of 2007, as available.
``(B) Inclusion of results.--The Secretary, acting through
the Director of NIH, shall--
``(i) expand the registry data bank to include the results
of applicable clinical trials (referred to in this subsection
as the `registry and results data bank');
``(ii) ensure that such results are made publicly available
through the Internet;
``(iii) post publicly a glossary for the lay public
explaining technical terms related to the results of clinical
trials; and
``(iv) in consultation with experts on risk communication,
provide information with the information included under
subparagraph (C) in the registry and results data bank to
help ensure that such information does not mislead the
patients or the public.
``(C) Basic results.--Not later than 1 year after the date
of the enactment of the Food and Drug Administration
Amendments Act of 2007, the Secretary shall include in the
registry and results data bank the following elements for
drugs that are approved under section 505 of the Federal
Food, Drug, and Cosmetic Act or licensed under section 351 of
this Act and devices that are cleared under section 510(k) of
the Federal Food, Drug, and Cosmetic Act or approved under
section 515 or 520(m) of such Act:
``(i) Demographic and baseline characteristics of patient
sample.--A table of the demographic and baseline data
collected overall and for each arm of the clinical trial to
describe the patients who participated in the clinical trial,
including the number of patients who dropped out of the
clinical trial and the number of patients excluded from the
analysis, if any.
``(ii) Primary and secondary outcomes.--The primary and
secondary outcome measures as submitted under paragraph
(2)(A)(ii)(I)(ll), and a table of values for each of the
primary and secondary outcome measures for each arm of the
clinical trial, including the results of scientifically
appropriate tests of the statistical significance of such
outcome measures.
``(iii) Point of contact.--A point of contact for
scientific information about the clinical trial results.
[[Page H10576]]
``(iv) Certain agreements.--Whether there exists an
agreement (other than an agreement solely to comply with
applicable provisions of law protecting the privacy of
participants) between the sponsor or its agent and the
principal investigator (unless the sponsor is an employer of
the principal investigator) that restricts in any manner the
ability of the principal investigator, after the completion
date of the trial, to discuss the results of the trial at a
scientific meeting or any other public or private forum, or
to publish in a scientific or academic journal information
concerning the results of the trial.
``(D) Expanded registry and results data bank.--
``(i) Expansion by rulemaking.--To provide more complete
results information and to enhance patient access to and
understanding of the results of clinical trials, not later
than 3 years after the date of the enactment of the Food and
Drug Administration Amendments Act of 2007, the Secretary
shall by regulation expand the registry and results data bank
as provided under this subparagraph.
``(ii) Clinical trials.--
``(I) Approved products.--The regulations under this
subparagraph shall require the inclusion of the results
information described in clause (iii) for--
``(aa) each applicable drug clinical trial for a drug that
is approved under section 505 of the Federal Food, Drug, and
Cosmetic Act or licensed under section 351 of this Act; and
``(bb) each applicable device clinical trial for a device
that is cleared under section 510(k) of the Federal Food,
Drug, and Cosmetic Act or approved under section 515 or
520(m) of such Act.
``(II) Unapproved products.--The regulations under this
subparagraph shall establish whether or not the results
information described in clause (iii) shall be required for--
``(aa) an applicable drug clinical trial for a drug that is
not approved under section 505 of the Federal Food, Drug, and
Cosmetic Act and not licensed under section 351 of this Act
(whether approval or licensure was sought or not); and
``(bb) an applicable device clinical trial for a device
that is not cleared under section 510(k) of the Federal Food,
Drug, and Cosmetic Act and not approved under section 515 or
section 520(m) of such Act (whether clearance or approval was
sought or not).
``(iii) Required elements.--The regulations under this
subparagraph shall require, in addition to the elements
described in subparagraph (C), information within each of the
following categories:
``(I) A summary of the clinical trial and its results that
is written in non-technical, understandable language for
patients, if the Secretary determines that such types of
summary can be included without being misleading or
promotional.
``(II) A summary of the clinical trial and its results that
is technical in nature, if the Secretary determines that such
types of summary can be included without being misleading or
promotional.
``(III) The full protocol or such information on the
protocol for the trial as may be necessary to help to
evaluate the results of the trial.
``(IV) Such other categories as the Secretary determines
appropriate.
``(iv) Results submission.--The results information
described in clause (iii) shall be submitted to the Director
of NIH for inclusion in the registry and results data bank as
provided by subparagraph (E), except that the Secretary shall
by regulation determine--
``(I) whether the 1-year period for submission of clinical
trial information described in subparagraph (E)(i) should be
increased from 1 year to a period not to exceed 18 months;
``(II) whether the clinical trial information described in
clause (iii) should be required to be submitted for an
applicable clinical trial for which the clinical trial
information described in subparagraph (C) is submitted to the
registry and results data bank before the effective date of
the regulations issued under this subparagraph; and
``(III) in the case when the clinical trial information
described in clause (iii) is required to be submitted for the
applicable clinical trials described in clause (ii)(II), the
date by which such clinical trial information shall be
required to be submitted, taking into account--
``(aa) the certification process under subparagraph
(E)(iii) when approval, licensure, or clearance is sought;
and
``(bb) whether there should be a delay of submission when
approval, licensure, or clearance will not be sought.
``(v) Additional provisions.--The regulations under this
subparagraph shall also establish--
``(I) a standard format for the submission of clinical
trial information under this paragraph to the registry and
results data bank;
``(II) additional information on clinical trials and
results that is written in nontechnical, understandable
language for patients;
``(III) considering the experience under the pilot quality
control project described in paragraph (5)(C), procedures for
quality control, including using representative samples, with
respect to completeness and content of clinical trial
information under this subsection, to help ensure that data
elements are not false or misleading and are non-promotional;
``(IV) the appropriate timing and requirements for updates
of clinical trial information, and whether and, if so, how
such updates should be tracked;
``(V) a statement to accompany the entry for an applicable
clinical trial when the primary and secondary outcome
measures for such clinical trial are submitted under
paragraph (4)(A) after the date specified for the submission
of such information in paragraph (2)(C); and
``(VI) additions or modifications to the manner of
reporting of the data elements established under subparagraph
(C).
``(vi) Consideration of world health organization data
set.--The Secretary shall consider the status of the
consensus data elements set for reporting clinical trial
results of the World Health Organization when issuing the
regulations under this subparagraph.
``(vii) Public meeting.--The Secretary shall hold a public
meeting no later than 18 months after the date of the
enactment of the Food and Drug Administration Amendments Act
of 2007 to provide an opportunity for input from interested
parties with regard to the regulations to be issued under
this subparagraph.
``(E) Submission of results information.--
``(i) In general.--Except as provided in clause (iii),
(iv), (v), and (vi) the responsible party for an applicable
clinical trial that is described in clause (ii) shall submit
to the Director of NIH for inclusion in the registry and
results data bank the clinical trial information described in
subparagraph (C) not later than 1 year, or such other period
as may be provided by regulation under subparagraph (D),
after the earlier of--
``(I) the estimated completion date of the trial as
described in paragraph (2)(A)(ii)(I)(jj)); or
``(II) the actual date of completion.
``(ii) Clinical trials described.--An applicable clinical
trial described in this clause is an applicable clinical
trial subject to--
``(I) paragraph (2)(C); and
``(II)(aa) subparagraph (C); or
``(bb) the regulations issued under subparagraph (D).
``(iii) Delayed submission of results with certification.--
If the responsible party for an applicable clinical trial
submits a certification that clause (iv) or (v) applies to
such clinical trial, the responsible party shall submit to
the Director of NIH for inclusion in the registry and results
data bank the clinical trial information described in
subparagraphs (C) and (D) as required under the applicable
clause.
``(iv) Seeking initial approval of a drug or device.--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 initially approved
under section 515 or 520(m) of the Federal Food, Drug, and
Cosmetic Act, the responsible party shall submit to the
Director of NIH for inclusion in the registry and results
data bank the clinical trial information described in
subparagraphs (C) and (D) not later than 30 days after 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 or 520(m), as applicable.
``(v) Seeking approval of a new use for the drug or
device.--
``(I) In general.--With respect to an applicable clinical
trial where the manufacturer of the drug or device is the
sponsor of an applicable clinical trial, and such
manufacturer has filed, or will file within 1 year, an
application seeking approval under section 505 of the Federal
Food, Drug, and Cosmetic Act, licensing under section 351 of
this Act, or clearance under section 510(k), or approval
under section 515 or 520(m), of the Federal Food, Drug, and
Cosmetic Act for the use studied in such clinical trial
(which use is not included in the labeling of the approved
drug or device), then the responsible party shall submit to
the Director of NIH for inclusion in the registry and results
data bank the clinical trial information described in
subparagraphs (C) and (D) on the earlier of the date that is
30 days after the date--
``(aa) 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
or 520(m);
``(bb) the Secretary issues a letter, such as a complete
response letter, not approving the submission or not clearing
the submission, 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), 515, or
520(m); or
``(cc) except as provided in subclause (III), the
application or premarket notification under such section 505,
351, 510(k), 515, or 520(m) is withdrawn without resubmission
for no less than 210 days.
``(II) Requirement that each clinical trial in application
be treated the same.--If a manufacturer makes a certification
under clause (iii) that this clause applies 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 or report
for licensure, approval, or clearance (under section 351 of
this Act or section 505, 510(k), 515, or 520(m) of the
Federal Food, Drug, and Cosmetic Act, as applicable) of the
use studied in the clinical trial.
[[Page H10577]]
``(III) Two-year limitation.--The responsible party shall
submit to the Director of NIH for inclusion in the registry
and results data bank the clinical trial information subject
to subclause (I) on the date that is 2 years after the date a
certification under clause (iii) was made to the Director of
NIH, if an action referred to in item (aa), (bb), or (cc) of
subclause (I) has not occurred by such date.
``(vi) Extensions.--The Director of NIH may provide an
extension of the deadline for submission of clinical trial
information under clause (i) 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 a clinical trial.
``(F) Notice to director of nih.--The Commissioner of Food
and Drugs shall notify the Director of NIH when there is an
action described in subparagraph (E)(iv) or item (aa), (bb),
or (cc) of subparagraph (E)(v)(I) with respect to an
application or a report that includes a certification
required under paragraph (5)(B) of such action not later than
30 days after such action.
``(G) Posting of data.--The Director of NIH shall ensure
that the clinical trial information described in
subparagraphs (C) and (D) for an applicable clinical trial
submitted in accordance with this paragraph is posted
publicly in the registry and results database not later than
30 days after such submission.
``(H) Waivers regarding certain clinical trial results.--
The Secretary may waive any applicable requirements of this
paragraph for an applicable clinical trial, upon a written
request from the responsible party, if the Secretary
determines that extraordinary circumstances justify the
waiver and that providing the waiver is consistent with the
protection of public health, or in the interest of national
security. Not later than 30 days after any part of a waiver
is granted, the Secretary shall notify, in writing, the
appropriate committees of Congress of the waiver and provide
an explanation for why the waiver was granted.
``(I) Adverse events.--
``(i) Regulations.--Not later than 18 months after the date
of the enactment of the Food and Drug Administration
Amendments Act of 2007, the Secretary shall by regulation
determine the best method for including in the registry and
results data bank appropriate results information on serious
adverse and frequent adverse events for drugs described in
subparagraph (C) in a manner and form that is useful and not
misleading to patients, physicians, and scientists.
``(ii) Default.--If the Secretary fails to issue the
regulation required by clause (i) by the date that is 24
months after the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, clause (iii) shall
take effect.
``(iii) Additional elements.--Upon the application of
clause (ii), the Secretary shall include in the registry and
results data bank for drugs described in subparagraph (C), in
addition to the clinical trial information described in
subparagraph (C), the following elements:
``(I) Serious adverse events.--A table of anticipated and
unanticipated serious adverse events grouped by organ system,
with number and frequency of such event in each arm of the
clinical trial.
``(II) Frequent adverse events.--A table of anticipated and
unanticipated adverse events that are not included in the
table described in subclause (I) that exceed a frequency of 5
percent within any arm of the clinical trial, grouped by
organ system, with number and frequency of such event in each
arm of the clinical trial.
``(iv) Posting of other information.--In carrying out
clause (iii), the Secretary shall, in consultation with
experts in risk communication, post with the tables
information to enhance patient understanding and to ensure
such tables do not mislead patients or the lay public.
``(v) Relation to subparagraph (C).--Clinical trial
information included in the registry and results data bank
pursuant to this subparagraph is deemed to be clinical trial
information included in such data bank pursuant to
subparagraph (C).
``(4) Additional submissions of clinical trial
information.--
``(A) Voluntary submissions.--A responsible party for a
clinical trial that is not an applicable clinical trial, or
that is an applicable clinical trial that is not subject to
paragraph (2)(C), may submit complete clinical trial
information described in paragraph (2) or paragraph (3)
provided the responsible party submits clinical trial
information for each applicable clinical trial that is
required to be submitted under section 351 or under section
505, 510(k), 515, or 520(m) of the Federal Food, Drug, and
Cosmetic Act in an application or report for licensure,
approval, or clearance of the drug or device for the use
studied in the clinical trial.
``(B) Required submissions.--
``(i) In general.--Notwithstanding paragraphs (2) and (3)
and subparagraph (A), in any case in which the Secretary
determines for a specific clinical trial described in clause
(ii) that posting in the registry and results data bank of
clinical trial information for such clinical trial is
necessary to protect the public health--
``(I) the Secretary may require by notification that such
information be submitted to the Secretary in accordance with
paragraphs (2) and (3) except with regard to timing of
submission;
``(II) unless the responsible party submits a certification
under paragraph (3)(E)(iii), such information shall be
submitted not later than 30 days after the date specified by
the Secretary in the notification; and
``(III) failure to comply with the requirements under
subclauses (I) and (II) shall be treated as a violation of
the corresponding requirement of such paragraphs.
``(ii) Clinical trials described.--A clinical trial
described in this clause is--
``(I) an applicable clinical trial for a drug that is
approved under section 505 of the Federal Food, Drug, and
Cosmetic Act or licensed under section 351 of this Act or for
a device that is cleared under section 510(k) of the Federal
Food, Drug, and Cosmetic Act or approved under section 515 or
section 520(m) of such Act, whose completion date is on or
after the date 10 years before the date of the enactment of
the Food and Drug Administration Amendments Act of 2007; or
``(II) an applicable clinical trial that is described by
both by paragraph (2)(C) and paragraph (3)(D)(ii)(II)).
``(C) Updates to clinical trial data bank.--
``(i) Submission of updates.--The responsible party for an
applicable clinical trial shall submit to the Director of NIH
for inclusion in the registry and results data bank updates
to reflect changes to the clinical trial information
submitted under paragraph (2). Such updates--
``(I) shall be provided not less than once every 12 months,
unless there were no changes to the clinical trial
information during the preceding 12-month period;
``(II) shall include identification of the dates of any
such changes;
``(III) not later than 30 days after the recruitment status
of such clinical trial changes, shall include an update of
the recruitment status; and
``(IV) not later than 30 days after the completion date of
the clinical trial, shall include notification to the
Director that such clinical trial is complete.
``(ii) Public availability of updates.--The Director of NIH
shall make updates submitted under clause (i) publicly
available in the registry data bank. Except with regard to
overall recruitment status, individual site status, location,
and contact information, the Director of NIH shall ensure
that updates to elements required under subclauses (I) to (V)
of paragraph (2)(A)(ii) do not result in the removal of any
information from the original submissions or any preceding
updates, and information in such databases is presented in a
manner that enables users to readily access each original
element submission and to track the changes made by the
updates. The Director of NIH shall provide a link from the
table of primary and secondary outcomes required under
paragraph (3)(C)(ii) to the tracked history required under
this clause of the primary and secondary outcome measures
submitted under paragraph (2)(A)(ii)(I)(ll).
``(5) Coordination and compliance.--
``(A) Clinical trials supported by grants from federal
agencies.--
``(i) Grants from certain federal agencies.--If an
applicable clinical trial is funded in whole or in part by a
grant from any agency of the Department of Health and Human
Services, including the Food and Drug Administration, the
National Institutes of Health, or the Agency for Healthcare
Research and Quality, any grant or progress report forms
required under such grant shall include a certification that
the responsible party has made all required submissions to
the Director of NIH under paragraph (2) and (3).
``(ii) Verification by federal agencies.--The heads of the
agencies referred to in clause (i), as applicable, shall
verify that the clinical trial information for each
applicable clinical trial for which a grantee is the
responsible party has been submitted under paragraph (2) and
(3) before releasing any remaining funding for a grant or
funding for a future grant to such grantee.
``(iii) Notice and opportunity to remedy.--If the head of
an agency referred to in clause (i), as applicable, verifies
that a grantee has not submitted clinical trial information
as described in clause (ii), such agency head shall provide
notice to such grantee of such non-compliance and allow such
grantee 30 days to correct such non-compliance and submit the
required clinical trial information.
``(iv) Consultation with other federal agencies.--The
Secretary shall--
``(I) consult with other agencies that conduct research
involving human subjects in accordance with any section of
part 46 of title 45, Code of Federal Regulations (or any
successor regulations), to determine if any such research is
an applicable clinical trial; and
``(II) develop with such agencies procedures comparable to
those described in clauses (i), (ii), and (iii) to ensure
that clinical trial information for such applicable clinical
trial is submitted under paragraph (2) and (3).
``(B) Certification to accompany drug, biological product,
and device submissions.--At the time of submission of an
application under section 505 of the Federal Food, Drug, and
Cosmetic Act, section 515 of such Act, section 520(m) of such
Act, or section 351 of this Act, or submission of a report
under section 510(k) of such Act, such application or
submission shall be accompanied by a certification that all
applicable requirements of this subsection have been met.
[[Page H10578]]
Where available, such certification shall include the
appropriate National Clinical Trial control numbers.
``(C) Quality control.--
``(i) Pilot quality control project.--Until the effective
date of the regulations issued under paragraph (3)(D), the
Secretary, acting through the Director of NIH and the
Commissioner of Food and Drugs, shall conduct a pilot project
to determine the optimal method of verification to help to
ensure that the clinical trial information submitted under
paragraph (3)(C) is non-promotional and is not false or
misleading in any particular under subparagraph (D). The
Secretary shall use the publicly available information
described in paragraph (3)(A) and any other information
available to the Secretary about applicable clinical trials
to verify the accuracy of the clinical trial information
submitted under paragraph (3)(C).
``(ii) Notice of compliance.--If the Secretary determines
that any clinical trial information was not submitted as
required under this subsection, or was submitted but 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 not later than 30 days after such
notification.
``(D) Truthful clinical trial information.--
``(i) In general.--The clinical trial information submitted
by a responsible party under this subsection shall not be
false or misleading in any particular.
``(ii) Effect.--Clause (i) shall not have the effect of--
``(I) requiring clinical trial information with respect to
an applicable clinical trial to include information from any
source other than such clinical trial involved; or
``(II) requiring clinical trial information described in
paragraph (3)(D) to be submitted for purposes of paragraph
(3)(C).
``(E) Public notices.--
``(i) Notice of violations.--If the responsible party for
an applicable clinical trial fails to submit clinical trial
information for such clinical trial as required under
paragraphs (2) or (3), the Director of NIH shall include in
the registry and results data bank entry for such clinical
trial a notice--
``(I) that the responsible party is not in compliance with
this Act by--
``(aa) failing to submit required clinical trial
information; or
``(bb) submitting false or misleading clinical trial
information;
``(II) of the penalties imposed for the violation, if any;
and
``(III) whether the responsible party has corrected the
clinical trial information in the registry and results data
bank.
``(ii) Notice of failure to submit primary and secondary
outcomes.--If the responsible party for an applicable
clinical trial fails to submit the primary and secondary
outcomes as required under section 2(A)(ii)(I)(ll), the
Director of NIH shall include in the registry and results
data bank entry for such clinical trial a notice that the
responsible party is not in compliance by failing to register
the primary and secondary outcomes in accordance with this
act, and that the primary and secondary outcomes were not
publicly disclosed in the database before conducting the
clinical trial.
``(iii) Failure to submit statement.--The notice under
clause (i) for a violation described in clause (i)(I)(aa)
shall include the following statement: `The entry for this
clinical trial was not complete at the time of submission, as
required by law. This may or may not have any bearing on the
accuracy of the information in the entry.'.
``(iv) Submission of false information statement.--The
notice under clause (i) for a violation described in clause
(i)(I)(bb) shall include the following statement: `The entry
for this clinical trial was found to be false or misleading
and therefore not in compliance with the law.'.
``(v) Non-submission of statement.--The notice under clause
(ii) for a violation described in clause (ii) shall include
the following statement: `The entry for this clinical trial
did not contain information on the primary and secondary
outcomes at the time of submission, as required by law. This
may or may not have any bearing on the accuracy of the
information in the entry.'
``(vi) Compliance searches.--The Director of NIH shall
provide that the public may easily search the registry and
results data bank for entries that include notices required
under this subparagraph.
``(6) Limitation on disclosure of clinical trial
information.--
``(A) In general.--Nothing in this subsection (or under
section 552 of title 5, United States Code) shall require the
Secretary to publicly disclose, by any means other than the
registry and results data bank, information described in
subparagraph (B).
``(B) Information described.--Information described in this
subparagraph is--
``(i) information submitted to the Director of NIH under
this subsection, or information of the same general nature as
(or integrally associated with) the information so submitted;
and
``(ii) information not otherwise publicly available,
including because it is protected from disclosure under
section 552 of title 5, United States Code.
``(7) Authorization of appropriations.--There are
authorized to be appropriated to carry out this subsection
$10,000,000 for each fiscal year.''.
(b) Conforming Amendments.--
(1) Prohibited acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding
at the end the following:
``(jj)(1) The failure to submit the certification required
by section 402(j)(5)(B) of the Public Health Service Act, or
knowingly submitting a false certification under such
section.
``(2) The failure to submit clinical trial information
required under subsection (j) of section 402 of the Public
Health Service Act.
``(3) The submission of clinical trial information under
subsection (j) of section 402 of the Public Health Service
Act that is false or misleading in any particular under
paragraph (5)(D) of such subsection (j).''.
(2) Civil money penalties.--Subsection (f) of section 303
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333),
as redesignated by section 226, is amended--
(A) by redesignating paragraphs (3), (4), and (5) as
paragraphs (5), (6), and (7), respectively;
(B) by inserting after paragraph (2) the following:
``(3)(A) Any person who violates section 301(jj) shall be
subject to a civil monetary penalty of not more than $10,000
for all violations adjudicated in a single proceeding.
``(B) If a violation of section 301(jj) is not corrected
within the 30-day period following notification under section
402(j)(5)(C)(ii), the person shall, in addition to any
penalty under subparagraph (A), be subject to a civil
monetary penalty of not more than $10,000 for each day of the
violation after such period until the violation is
corrected.'';
(C) in paragraph (2)(C), by striking ``paragraph (3)(A)''
and inserting ``paragraph (5)(A)'';
(D) in paragraph (5), as so redesignated, by striking
``paragraph (1) or (2)'' each place it appears and inserting
``paragraph (1), (2),or (3)'';
(E) in paragraph (6), as so redesignated, by striking
``paragraph (3)(A)'' and inserting ``paragraph (5)(A)''; and
(F) in paragraph (7), as so redesignated, by striking
``paragraph (4)'' each place it appears and inserting
``paragraph (6)''.
(3) New drugs and devices.--
(A) Investigational new drugs.--Section 505(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is
amended in paragraph (4), by adding at the end the following:
``The Secretary shall update such regulations to require
inclusion in the informed consent documents and process a
statement that clinical trial information for such clinical
investigation has been or will be submitted for inclusion in
the registry data bank pursuant to subsection (j) of section
402 of the Public Health Service Act.''.
(B) New drug applications.--Section 505(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by
adding at the end the following:
``(6) An application submitted under this subsection shall
be accompanied by the certification required under section
402(j)(5)(B) of the Public Health Service Act. Such
certification shall not be considered an element of such
application.''.
(C) Device reports under section 510(k).--Section 510(k) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k))
is amended by adding at the end the following:
``A notification submitted under this subsection that
contains clinical trial data for an applicable device
clinical trial (as defined in section 402(j)(1) of the Public
Health Service Act) shall be accompanied by the certification
required under section 402(j)(5)(B) of such Act. Such
certification shall not be considered an element of such
notification.''.
(D) Device premarket approval application.--Section
515(c)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360e(c)(1)) is amended--
(i) in subparagraph (F), by striking ``; and'' and
inserting a semicolon;
(ii) by redesignating subparagraph (G) as subparagraph (H);
and
(iii) by inserting after subparagraph (F) the following:
``(G) the certification required under section 402(j)(5)(B)
of the Public Health Service Act (which shall not be
considered an element of such application); and''.
(E) Humanitarian device exemption.--Section 520(m)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c))
is amended in the first sentence in the matter following
subparagraph (C), by inserting at the end before the period
``and such application shall include the certification
required under section 402(j)(5)(B) of the Public Health
Service Act (which shall not be considered an element of such
application)''.
(c) Surveillances.--Not later than 12 months after the date
of the enactment of this Act, the Secretary of Health and
Human Services shall issue guidance on how the requirements
of section 402(j) of the Public Health Service Act, as added
by this section, apply to a pediatric postmarket surveillance
described in paragraph (1)(A)(ii)(II) of such section 402(j)
that is not a clinical trial.
(d) Preemption.--
(1) In general.--Upon the expansion of the registry and
results data bank under section 402(j)(3)(D) of the Public
Health Service Act, as added by this section, no State or
political subdivision of a State may establish or continue in
effect any requirement for the registration of clinical
trials or 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
[[Page H10579]]
submitted in compliance with subsection (j) of section 402 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 of Health and Human Services 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 registry and results
data bank under such subsection (j), if submitted in
compliance with such subsection, 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.).
TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS
Subtitle A--Postmarket Studies and Surveillance
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 (D), 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 data deemed appropriate by the Secretary,
including information regarding chemically-related or
pharmacologically-related drugs.
``(B) Purposes of study or clinical 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 an unexpected serious risk when
available data indicates the potential for a serious risk.
``(C) Establishment of requirement after approval of
covered application.--The Secretary may require a
postapproval study or studies or postapproval clinical 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.
``(D) Determination by secretary.--
``(i) Postapproval studies.--The Secretary may not require
the responsible person to conduct a study under this
paragraph, unless the Secretary makes a determination that
the reports under subsection (k)(1) and the active postmarket
risk identification and analysis system as available under
subsection (k)(3) will not be sufficient to meet the purposes
set forth in subparagraph (B).
``(ii) Postapproval clinical trials.--The Secretary may not
require the responsible person to conduct a clinical trial
under this paragraph, unless the Secretary makes a
determination that a postapproval study or studies will not
be sufficient to meet the purposes set forth in subparagraph
(B).
``(E) Notification; timetables; periodic reports.--
``(i) Notification.--The Secretary shall notify the
responsible person regarding a requirement under this
paragraph to conduct a postapproval study or clinical trial
by the target dates for communication of feedback from the
review team to the responsible person regarding proposed
labeling and postmarketing study commitments as set forth in
the letters described in section 101(c) of the Food and Drug
Administration Amendments Act of 2007.
``(ii) Timetable; periodic reports.--For each study or
clinical trial required to be conducted under this paragraph,
the Secretary shall require that the responsible person
submit a timetable for completion of the study or clinical
trial. With respect to each study required to be conducted
under this paragraph or otherwise undertaken by the
responsible person to investigate a safety issue, the
Secretary shall require the responsible person to
periodically report to the Secretary on the status of such
study including whether any difficulties in completing the
study have been encountered. With respect to each clinical
trial required to be conducted under this paragraph or
otherwise undertaken by the responsible person to investigate
a safety issue, the Secretary shall require the responsible
person to periodically report to the Secretary on 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 the requirements under section
402(j) of the Public Health Service Act. If the responsible
person fails to comply with such timetable or violates any
other requirement of this subparagraph, the responsible
person shall be considered in violation of this subsection,
unless the responsible person demonstrates good cause for
such noncompliance or such other violation. The Secretary
shall determine what constitutes good cause under the
preceding sentence.
``(F) Dispute resolution.--The responsible person may
appeal a requirement to conduct a study or clinical trial
under this paragraph using dispute resolution procedures
established by the Secretary in regulation and guidance.
``(4) Safety labeling changes requested by secretary.--
``(A) New safety information.--If the Secretary becomes
aware of new safety information that the Secretary believes
should be included in the labeling of the drug, the Secretary
shall promptly notify the responsible person or, if the same
drug approved under section 505(b) is not currently marketed,
the holder of an approved application under 505(j).
``(B) Response to notification.--Following notification
pursuant to subparagraph (A), the responsible person or the
holder of the approved application under section 505(j) 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 or
the holder of the approved application under section 505(j)
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 reasons
why no labeling change is necessary, the Secretary shall
initiate discussions 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 or the holder of
the approved application under section 505(j) 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 or the holder of the approved
application under section 505(j) shall submit a supplement
containing the labeling change.
``(F) Dispute resolution.--Within 5 days of receiving an
order under subparagraph (E), the responsible person or the
holder of the approved application under section 505(j) may
appeal using dispute resolution procedures established by the
Secretary in regulation and guidance.
``(G) Violation.--If the responsible person or the holder
of the approved application under section 505(j) has not
submitted a supplement within 15 days of the date of such
order under subparagraph (E), and there is no appeal or
dispute resolution proceeding pending, the responsible person
or holder shall be considered to be in violation of this
subsection. If at the conclusion of any dispute resolution
procedures the Secretary determines that a supplement must be
submitted and such a supplement is not submitted within 15
days of the date of that determination, the responsible
person or holder shall be in violation of this subsection.
``(H) Public health threat.--Notwithstanding subparagraphs
(A) through (F), if the Secretary concludes that such a
labeling change is necessary to protect the public health,
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 or the holder of the approved application under
section 505(j) to maintain its label in accordance with
existing requirements, including subpart B of part 201 and
sections 314.70 and 601.12 of title 21, Code of Federal
Regulations (or any successor regulations).
``(5) Non-delegation.--Determinations by the Secretary
under this subsection for a
[[Page H10580]]
drug shall be made by individuals at or above the level of
individuals empowered to approve a drug (such as division
directors within the Center for Drug Evaluation and
Research).
``(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 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.
``(2) Certain postmarket studies.--The failure to conduct a
postmarket study under section 506, subpart H of part 314, or
subpart E of part 601 of title 21, Code of Federal
Regulations (or any successor regulations), 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.--If the Secretary, in consultation
with the office responsible for reviewing the drug and the
office responsible for postapproval safety with respect to
the drug, determines that a risk evaluation and mitigation
strategy is necessary to ensure that the benefits of the drug
outweigh the risks of the drug, and informs the person who
submits such application of such determination, then such
person shall submit to the Secretary as part of such
application a proposed risk evaluation and mitigation
strategy. In making such a determination, the Secretary 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) Whether the drug is a new molecular entity.
``(2) Postapproval requirement.--
``(A) In general.--If the Secretary has approved a covered
application (including an application approved before the
effective date of this section) and did not when approving
the application require a risk evaluation and mitigation
strategy under paragraph (1), the Secretary, in consultation
with the offices described in paragraph (1), may subsequently
require such a strategy for the drug involved (including when
acting on a supplemental application seeking approval of a
new indication for use of the drug) 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 reasonable 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) Abbreviated new drug applications.--The applicability
of this section to an application under section 505(j) is
subject to subsection (i).
``(4) Non-delegation.--Determinations by the Secretary
under this subsection for a drug shall be made by individuals
at or above the level of individuals empowered to approve a
drug (such as division directors within the Center for Drug
Evaluation and Research).
``(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'
means an application referred to in section 505(p)(1)(A).
``(3) New safety information.--The term `new safety
information', with respect to a drug, means information
derived from a clinical trial, an adverse event report, a
postapproval study (including a study under section
505(o)(3)), or peer-reviewed biomedical literature; data
derived from the postmarket risk identification and analysis
system under section 505(k); or other scientific data deemed
appropriate by the Secretary about--
``(A) a serious risk or an unexpected serious risk
associated with use of the drug that the Secretary has become
aware of (that may be based on a new analysis of existing
information) 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.
``(4) Serious adverse drug experience.--The term `serious
adverse drug experience' is an adverse drug experience 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;
``(E) data derived from the postmarket risk identification
and analysis system under section 505(k)(4); or
``(F) other scientific data deemed appropriate by the
Secretary.
``(7) Responsible person.--The term `responsible person'
means the person submitting a covered application or the
holder of the approved such application.
``(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, in
consultation with the office responsible for reviewing the
drug and the office responsible for postapproval safety with
respect to the drug, 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) includes an assessment, by the date that is 18 months
after the strategy is initially approved;
``(2) includes an assessment by the date that is 3 years
after the strategy is initially approved;
``(3) includes an assessment in the seventh year after the
strategy is so approved; and
``(4) subject to paragraphs (1), (2), and (3)--
``(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, in consultation with the
offices described in subsection (c)(2), may under such
subsection 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 each element
involved.
``(2) Medication guide; patient package insert.--The risk
evaluation and mitigation strategy for a drug may require
that, as applicable, 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
[[Page H10581]]
``(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 (including under this paragraph).
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) Providing Safe Access for Patients to Drugs With
Known Serious Risks That Would Otherwise Be Unavailable.--
``(1) Allowing safe access to drugs with known serious
risks.--The Secretary, in consultation with the offices
described in subsection (c)(2), may require that the risk
evaluation and mitigation strategy for a drug include such
elements as are necessary to assure safe use of the drug,
because of its inherent toxicity or potential harmfulness, if
the Secretary determines that--
``(A) the drug, which has been shown to be effective, but
is associated with a serious adverse drug experience, can be
approved only if, or would be withdrawn unless, such elements
are required as part of such strategy to mitigate a specific
serious risk listed in the labeling of the drug; and
``(B) for a drug initially approved without elements to
assure safe use, other elements under subsections (c), (d),
and (e) are not sufficient to mitigate such serious risk.
``(2) Assuring access and minimizing burden.--Such elements
to assure safe use under paragraph (1) shall--
``(A) be commensurate with the specific serious risk listed
in the labeling of the drug;
``(B) within 30 days of the date on which any element under
paragraph (1) is imposed, be posted publicly by the Secretary
with an explanation of how such elements will mitigate the
observed safety risk;
``(C) considering such risk, 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 to assure safe use.--The elements to assure
safe use under paragraph (1) shall include 1 or more goals to
mitigate a specific serious risk listed in the labeling of
the drug and, to mitigate such risk, may require that--
``(A) health care providers who prescribe the drug have
particular training or experience, or are specially certified
(the opportunity to obtain such training or certification
with respect to the drug shall be available to any willing
provider from a frontier area in a widely available training
or certification method (including an on-line course or via
mail) as approved by the Secretary at reasonable cost to the
provider);
``(B) pharmacies, practitioners, or health care settings
that dispense the drug are specially certified (the
opportunity to obtain such certification shall be 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 elements to assure safe
use under paragraph (1) that are described in subparagraphs
(B), (C), and (D) of paragraph (3) may include a system
through which the applicant is able to take reasonable steps
to--
``(A) monitor and evaluate implementation of such elements
by health care providers, pharmacists, and other parties in
the health care system who are responsible for implementing
such elements; and
``(B) work to improve implementation of such elements by
such persons.
``(5) Evaluation of elements to assure safe use.--The
Secretary, through the Drug Safety and Risk Management
Advisory Committee (or 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.
``(6) Additional mechanisms to assure access.--The
mechanisms under section 561 to provide for expanded access
for patients with serious or life-threatening diseases or
conditions may be used to provide access for patients with a
serious or life-threatening disease or condition, the
treatment of which is not an approved use for the drug, to a
drug that is subject to elements to assure safe use under
this subsection. The Secretary shall promulgate regulations
for how a physician may provide the drug under the mechanisms
of section 561.
``(7) Waiver in public health emergencies.--The Secretary
may waive any requirement of 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
requirement 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.
``(8) Limitation.--No holder of an approved covered
application shall use any element to assure safe use required
by the Secretary under this subsection to block or delay
approval of an application under section 505(b)(2) or (j) or
to prevent application of such element under subsection
(i)(1)(B) to a drug that is the subject of an abbreviated new
drug application.
``(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, in consultation with the offices
described in subsection (c)(2), 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, in
consultation with the offices described in subsection (c)(2),
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 elements to assure safe
use are meeting the goal or whether the goal or such elements
should be modified;
``(B) with respect to any postapproval study required under
section 505(o) or otherwise undertaken by the responsible
person to investigate a safety issue, 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) or otherwise undertaken by the
responsible party to investigate a safety issue, 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 subsections
(i) and (j) of section 402 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
[[Page H10582]]
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 as provided in subsection (d)(3), including to
eliminate assessments; or
``(B) adding, modifying, or removing an element to assure
safe use under subsection (f).
``(h) Review of Proposed Strategies; Review of Assessments
of Approved Strategies.--
``(1) In general.--The Secretary, in consultation with the
offices described in subsection (c)(2), 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) Discussion.--The Secretary, in consultation with the
offices described in subsection (c)(2), shall initiate
discussions with the responsible person for purposes of this
subsection to determine a strategy not later than 60 days
after any such assessment is submitted or, in the case of an
assessment submitted under subsection (g)(2)(D), not later
than 30 days after such assessment is submitted.
``(3) Action.--
``(A) In general.--Unless the dispute resolution process
described under paragraph (4) or (5) applies, the Secretary,
in consultation with the offices described in subsection
(c)(2), shall describe any required risk evaluation and
mitigation strategy for a drug, or any modification to any
required strategy--
``(i) as part of the action letter on the application, when
a proposed strategy is submitted under subsection (a) or a
modification to the strategy is proposed as part of an
assessment of the strategy submitted under subsection (g)(1);
or
``(ii) in an order issued not later than 90 days after the
date discussions of such modification begin under paragraph
(2), when a modification to the strategy is proposed as part
of an assessment of the strategy 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.
``(4) Dispute resolution at initial approval.--If a
proposed risk evaluation and mitigation strategy is submitted
under subsection (a)(1) in an application for initial
approval of a drug and there is a dispute about the strategy,
the responsible person shall use the major dispute resolution
procedures as set forth in the letters described in section
101(c) of the Food and Drug Administration Amendments Act of
2007.
``(5) Dispute resolution in all other cases.--
``(A) Request for review.--
``(i) In general.--Not earlier than 15 days, and not later
than 35 days, after discussions under paragraph (2) 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 Drug Administration to reach agreement on the strategy,
including appeals as described in the letters described in
section 101(c) of the Food and Drug Administration Amendments
Act of 2007 for procedural or scientific matters involving
the review of human drug applications and supplemental
applications that cannot be resolved at the divisional level.
At the time a review has been scheduled under subparagraph
(B) and notice of such review has been posted, the
responsible person shall either withdraw the request under
subparagraph (A) or terminate the use of such administrative
appeals.
``(ii) Agreement terminates dispute resolution.--At any
time before a decision and order is issued under subparagraph
(G) , the Secretary (in consultation with the offices
described in subsection (c)(2)) 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 via written or oral
presentation; 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 90 days of the meeting.
The Secretary shall redact the transcript to protect any
trade secrets and other information that is exempted from
disclosure under section 552 of title 5, United States Code,
or section 552a 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 for the action letter on the
application; 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
for the action letter on the application 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 (2) 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 (4) or (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, in consultation with the offices described in
subsection (c)(2), 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.
``(B) Notice.--If the Secretary defers an assessment under
subparagraph (A), the Secretary shall--
[[Page H10583]]
``(i) give notice of the deferral to the holder of the
approved covered application not later than 5 days after the
deferral;
``(ii) publish the deferral in the Federal Register; and
``(iii) give notice to the public of any public meetings to
be convened under subparagraph (A), including a description
of the deferral.
``(C) Public meetings.--Such public meetings may include--
``(i) 1 or more meetings of the responsible person 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.
``(D) Action.--After considering the discussions from any
meetings under subparagraph (A), 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, in
consultation with the offices described in subsection (c)(2),
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 responsible person.
``(9) Effect.--Use of the processes described in paragraphs
(7) and (8) shall not be the sole source of delay of 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) Elements to assure safe 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).
The Secretary may waive the requirement under the preceding
sentence for a drug that is the subject of an abbreviated new
drug application, and permit the applicant to use a
different, comparable aspect of the elements to assure safe
use, if the Secretary determines that--
``(i) the burden of creating a single, shared system
outweighs the benefit of a single, system, taking into
consideration the impact on health care providers, patients,
the applicant for the abbreviated new drug application, and
the holder of the reference drug product; or
``(ii) an aspect of the elements to assure safe use for the
applicable listed drug is claimed by a patent that has not
expired or is a method or process that, as a trade secret, is
entitled to protection, and the applicant for the abbreviated
new drug application certifies that it has sought a license
for use of an aspect of the elements to assure safe use for
the applicable listed drug and that it was unable to obtain a
license.
A certification under clause (ii) shall include a description
of the efforts made by the applicant for the abbreviated new
drug application to obtain a license. In a case described in
clause (ii), the Secretary may seek to negotiate a voluntary
agreement with the owner of the patent, method, or process
for a license under which the applicant for such abbreviated
new drug application may use an aspect of the elements to
assure safe use, if required under subsection (f) for the
applicable listed drug, that is claimed by a patent that has
not expired or is a method or process that as a trade secret
is entitled to protection.
``(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, including the offices
responsible for postapproval safety of drugs;
``(C) include at least 1 representative each from 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) Postmarket Studies and Clinical Trials; Labeling;
Risk Evaluation and Mitigation Strategy.--A person that
submits an application for a license under this paragraph is
subject to sections 505(o), 505(p), and 505-1 of the Federal
Food, Drug, and Cosmetic Act.''; and
(2) in subsection (j), by inserting ``, including the
requirements under sections 505(o), 505(p), and 505-1 of such
Act,'' after ``, and Cosmetic Act''.
(d) Advertisements of Drugs.--The Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.), as amended by section
801(b), is amended--
(1) in section 301 (21 U.S.C. 331), by adding at the end
the following:
``(kk) The dissemination of a television advertisement
without complying with section 503B.''; and
(2) 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 with respect to information included in the
label of the drug--
``(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 specific
population groups, including elderly populations, children,
and racial and ethnic minorities.
``(c) No Authority to Require Changes.--Except as provided
by subsection (e), 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 or section 351 of the Public Health Service
Act, 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 requirements under section
502(n) or 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, conspicuous, and neutral manner.''.
(B) Regulations to determine clear, conspicuous, and
neutral manner.--Not later than 30 months after the date of
the enactment of the Food and Drug Administration Amendments
Act of 2007, 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
[[Page H10584]]
U.S.C. 333), as amended by section 801(b), is amended 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 or causes
another party to disseminate 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)(4)) 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. With respect to
advertisements that appear in magazines or other publications
that are published less frequently than daily, each issue
date (whether weekly or monthly) shall be treated as a single
day for the purpose of calculating the number of violations
under this paragraph.
``(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) The Secretary, in determining the amount of the civil
penalty under paragraph (1), 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
or caused another party to disseminate 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 or
caused the advertisement to be created acted in good faith.
``(I) Whether the person who created the advertisement or
caused the advertisement to be created 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 or caused another party to disseminate such
advertisement after incorporating each comment received from
the Secretary.
``(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) 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.''.
(5) Report on direct-to-consumer advertising.--Not later
than 24 months after the date of the enactment of this Act,
the Secretary of Health and Human Services 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 utilize the
Advisory Committee on Risk Communication established under
this Act to advise the Secretary with respect to such report.
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 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 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 of Health and Human
Services shall submit the 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.
(6) Rulemaking.--Section 502(n) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352(n)) is amended by striking
``the procedure specified in section 701(e) of this Act'' and
inserting ``section 701(a)''.
(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 responsible person (as such term is used in section
505-1) 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 amended by section 801(b), is
amended--
(1) by inserting after paragraph (3), as added by section
801(b)(2), the following:
``(4)(A) Any responsible person (as such term is used in
section 505-1) that violates a requirement of section 505(o),
505(p), or 505-1 shall be subject to a civil monetary penalty
of--
``(i) not more than $250,000 per violation, and not to
exceed $1,000,000 for all such violations adjudicated in a
single proceeding; or
``(ii) in the case of a violation that continues after the
Secretary provides written notice to the responsible person,
the responsible person shall be subject to a civil monetary
penalty of $250,000 for the first 30-day period (or any
portion thereof) that the responsible person continues to be
in violation, and such amount shall double for every 30-day
period thereafter that the violation continues, not to exceed
$1,000,000 for any 30-day period, and not to exceed
$10,000,000 for all such violations adjudicated in a single
proceeding.
``(B) In determining the amount of a civil penalty under
subparagraph (A)(ii), the Secretary shall take into
consideration whether the responsible person is making
efforts toward correcting the violation of the requirement of
section 505(o), 505(p), or 505-1 for which the responsible
person is subject to such civil penalty.''; and
(2) in paragraph (5), as redesignated by section
801(b)(2)(A), by striking ``paragraph (1), (2), or (3)'' each
place it appears and inserting ``paragraph (1), (2), (3), or
(4)''.
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
[[Page H10585]]
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
may 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. ACTIVE POSTMARKET RISK IDENTIFICATION AND ANALYSIS.
(a) In General.--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) Active postmarket risk identification.--
``(A) Definition.--In this paragraph, the term `data'
refers to information with respect to a drug approved under
this section or under section 351 of the Public Health
Service Act, including claims data, patient survey data,
standardized analytic files that allow for the pooling and
analysis of data from disparate data environments, and any
other data deemed appropriate by the Secretary.
``(B) Development of postmarket risk identification and
analysis methods.--The Secretary shall, not later than 2
years after the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, in collaboration with
public, academic, and private entities--
``(i) develop methods to obtain access to disparate data
sources including the data sources specified in subparagraph
(C);
``(ii) develop validated methods for the establishment of a
postmarket risk identification and analysis system to link
and analyze safety data from multiple sources, with the goals
of including, in aggregate--
``(I) at least 25,000,000 patients by July 1, 2010; and
``(II) at least 100,000,000 patients by July 1, 2012; and
``(iii) convene a committee of experts, including
individuals who are recognized in the field of protecting
data privacy and security, to make recommendations to the
Secretary on the development of tools and methods for the
ethical and scientific uses for, and communication of,
postmarketing data specified under subparagraph (C),
including recommendations on the development of effective
research methods for the study of drug safety questions.
``(C) Establishment of the postmarket risk identification
and analysis system.--
``(i) In general.--The Secretary shall, not later than 1
year after the development of the risk identification and
analysis methods under subparagraph (B), establish and
maintain procedures--
``(I) for risk identification and analysis based on
electronic health data, in compliance with the regulations
promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996, and in a manner
that does not disclose individually identifiable health
information in violation of paragraph (4)(B);
``(II) for the reporting (in a standardized form) of data
on all serious adverse drug experiences (as defined in
section 505-1(b)) submitted to the Secretary under paragraph
(1), and those adverse events submitted by patients,
providers, and drug sponsors, when appropriate;
``(III) to provide for active adverse event surveillance
using the following data sources, as available:
``(aa) Federal health-related electronic data (such as data
from the Medicare program and the health systems of the
Department of Veterans Affairs);
``(bb) private sector health-related electronic data (such
as pharmaceutical purchase data and health insurance claims
data); and
``(cc) other data as the Secretary deems necessary to
create a robust system to identify adverse events and
potential drug safety signals;
``(IV) to identify certain trends and patterns with respect
to data accessed by the system;
``(V) to provide regular reports to the Secretary
concerning adverse event trends, adverse event patterns,
incidence and prevalence of adverse events, and other
information the Secretary determines appropriate, which may
include data on comparative national adverse event trends;
and
``(VI) to enable the program to export data in a form
appropriate for further aggregation, statistical analysis,
and reporting.
``(ii) Timeliness of reporting.--The procedures established
under clause (i) shall ensure that such data are accessed,
analyzed, and reported in a timely, routine, and systematic
manner, taking into consideration the need for data
completeness, coding, cleansing, and standardized analysis
and transmission.
``(iii) Private sector resources.--To ensure the
establishment of the active postmarket risk identification
and analysis system under this subsection not later than 1
year after the development of the risk identification and
analysis methods under subparagraph (B), as required under
clause (i), the Secretary may, on a temporary or permanent
basis, implement systems or products developed by private
entities.
``(iv) Complementary approaches.--To the extent the active
postmarket risk identification and analysis system under this
subsection is not sufficient to gather data and information
relevant to a priority drug safety question, the Secretary
shall develop, support, and participate in complementary
approaches to gather and analyze such data and information,
including--
``(I) approaches that are complementary with respect to
assessing the safety of use of a drug in domestic populations
not included, or underrepresented, in the trials used to
approve the drug (such as older people, people with
comorbidities, pregnant women, or children); and
``(II) existing approaches such as the Vaccine Adverse
Event Reporting System and the Vaccine Safety Datalink or
successor databases.
``(v) Authority for contracts.--The Secretary may enter
into contracts with public and private entities to fulfill
the requirements of this subparagraph.
``(4) Advanced analysis of drug safety data.--
``(A) Purpose.--The Secretary shall establish
collaborations with public, academic, and private entities,
which may include the Centers for Education and Research on
Therapeutics under section 912 of the Public Health Service
Act, to provide for advanced analysis of drug safety data
described in paragraph (3)(C) and other information that is
publicly available or is provided by the Secretary, in order
to--
``(i) improve the quality and efficiency of postmarket drug
safety risk-benefit analysis;
``(ii) provide the Secretary with routine access to outside
expertise to study advanced drug safety questions; and
``(iii) enhance the ability of the Secretary to make timely
assessments based on drug safety data.
``(B) Privacy.--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.
``(C) Public process for priority questions.--At least
biannually, the Secretary shall seek recommendations from the
Drug Safety and Risk Management Advisory Committee (or any
successor committee) and from other advisory committees, as
appropriate, to the Food and Drug Administration on--
``(i) priority drug safety questions; and
``(ii) mechanisms for answering such questions, including
through--
``(I) active risk identification under paragraph (3); and
``(II) when such risk identification is not sufficient,
postapproval studies and clinical trials under subsection
(o)(3).
``(D) Procedures for the development of drug safety
collaborations.--
``(i) In general.--Not later than 180 days after the date
of the establishment of the active postmarket risk
identification and analysis system under this subsection, the
Secretary shall establish and implement procedures under
which the Secretary may routinely contract with one or more
qualified entities to--
``(I) classify, analyze, or aggregate data described in
paragraph (3)(C) and information that is publicly available
or is provided by the Secretary;
``(II) allow for prompt investigation of priority drug
safety questions, including--
``(aa) unresolved safety questions for drugs or classes of
drugs; and
``(bb) for a newly-approved drugs, safety signals from
clinical trials used to approve the drug and other
preapproval trials; rare, serious drug side effects; and the
safety of use in domestic populations not included, or
underrepresented, in the trials used to approve the drug
(such as older people, people with comorbidities, pregnant
women, or children);
``(III) perform advanced research and analysis on
identified drug safety risks;
``(IV) focus postapproval studies and clinical trials under
subsection (o)(3) more effectively on cases for which reports
under paragraph (1) and other safety signal detection is not
sufficient to resolve whether there is an elevated risk of a
serious adverse event associated with the use of a drug; and
``(V) carry out other activities as the Secretary deems
necessary to carry out the purposes of this paragraph.
``(ii) Request for specific methodology.--The procedures
described in clause (i) shall permit the Secretary to request
that a specific methodology be used by the qualified entity.
The qualified entity shall work with the Secretary to
finalize the methodology to be used.
``(E) Use of analyses.--The Secretary shall provide the
analyses described in this paragraph, including the methods
and results of such analyses, about a drug to the sponsor or
sponsors of such drug.
``(F) Qualified entities.--
``(i) In general.--The Secretary shall enter into contracts
with a sufficient number of qualified entities to develop and
provide information to the Secretary in a timely manner.
[[Page H10586]]
``(ii) Qualification.--The Secretary shall enter into a
contract with an entity under clause (i) only if the
Secretary determines that the entity has a significant
presence in the United States and has one or more of the
following qualifications:
``(I) The research, statistical, epidemiologic, or clinical
capability and expertise to conduct and complete the
activities under this paragraph, including the capability and
expertise to provide the Secretary de-identified data
consistent with the requirements of this subsection.
``(II) An information technology infrastructure in place to
support electronic data and operational standards to provide
security for such data.
``(III) Experience with, and expertise on, the development
of drug safety and effectiveness research using electronic
population data.
``(IV) An understanding of drug development or risk/benefit
balancing in a clinical setting.
``(V) Other expertise which the Secretary deems necessary
to fulfill the activities under this paragraph.
``(G) Contract requirements.--Each contract with a
qualified entity under subparagraph (F)(i) shall contain the
following requirements:
``(i) Ensuring privacy.--The qualified entity shall ensure
that the entity will not use data under this subsection in a
manner that--
``(I) violates the regulations promulgated under section
264(c) of the Health Insurance Portability and Accountability
Act of 1996;
``(II) violates sections 552 or 552a of title 5, United
States Code, with regard to the privacy of individually-
identifiable beneficiary health information; or
``(III) discloses individually identifiable health
information when presenting drug safety signals and trends or
when responding to inquiries regarding drug safety signals
and trends.
Nothing in this clause prohibits lawful disclosure for other
purposes.
``(ii) Component of another organization.--If a qualified
entity is a component of another organization--
``(I) the qualified entity shall establish appropriate
security measures to maintain the confidentiality and privacy
of such data; and
``(II) the entity shall not make an unauthorized disclosure
of such data to the other components of the organization in
breach of such confidentiality and privacy requirement.
``(iii) Termination or nonrenewal.--If a contract with a
qualified entity under this subparagraph is terminated or not
renewed, the following requirements shall apply:
``(I) Confidentiality and privacy protections.--The entity
shall continue to comply with the confidentiality and privacy
requirements under this paragraph with respect to all data
disclosed to the entity.
``(II) Disposition of data.--The entity shall return any
data disclosed to such entity under this subsection to which
it would not otherwise have access or, if returning the data
is not practicable, destroy the data.
``(H) Competitive procedures.--The Secretary shall use
competitive procedures (as defined in section 4(5) of the
Federal Procurement Policy Act) to enter into contracts under
subparagraph (G).
``(I) Review of contract in the event of a merger or
acquisition.--The Secretary shall review the contract with a
qualified entity under this paragraph in the event of a
merger or acquisition of the entity in order to ensure that
the requirements under this paragraph will continue to be
met.
``(J) Coordination.--In carrying out this paragraph, the
Secretary shall provide for appropriate communications to the
public, scientific, public health, and medical communities,
and other key stakeholders, and to the extent practicable
shall coordinate with the activities of private entities,
professional associations, or other entities that may have
sources of drug safety data.''.
(b) Rule of Construction.--Nothing in this section or the
amendment made by this section shall be construed to prohibit
the lawful disclosure or use of data or information by an
entity other than as described in paragraph (4)(B) or (4)(G)
of section 505(k) of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (a).
(c) Report to Congress.--Not later than 4 years after the
date of the enactment of this Act, the Secretary shall report
to the Congress on the ways in which the Secretary has used
the active postmarket risk identification and analysis system
described in paragraphs (3) and (4) of section 505(k) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection
(a), to identify specific drug safety signals and to better
understand the outcomes associated with drugs marketed in the
United States.
(d) Authorization of Appropriations.--To carry out
activities under the amendment made by this section 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 to carry out the amendment made
by this section, in addition to such funds, $25,000,000 for
each of fiscal years 2008 through 2012.
(e) 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 privacy, confidentiality,
and security issues relating to accessing, transmitting, and
maintaining data for the active postmarket risk
identification and analysis system described in paragraphs
(3) and (4) of section 505(k) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), 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 privacy, confidentiality, and security of this data
or otherwise address privacy, confidentiality, and security
issues to ensure the effective operation of such active
postmarket identification and analysis system.
SEC. 906. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER
ADVERTISEMENTS OF DRUGS.
(a) Published Direct-to-Consumer Advertisements.--Section
502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
352), as amended by section 901(d)(6), is further amended by
inserting ``and in the case of published direct-to-consumer
advertisements the following statement printed in conspicuous
text: `You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.','' after ``section 701(a),''.
(b) Study.--
(1) In general.--In the case of direct-to-consumer
television advertisements, the Secretary of Health and Human
Services, in consultation with the Advisory Committee on Risk
Communication under section 567 of the Federal Food, Drug,
and Cosmetic Act (as added by section 917), shall, not later
than 6 months after the date of the enactment of this Act,
conduct a study to determine if the statement in section
502(n) of such Act (as added by subsection (a)) required with
respect to published direct-to-consumer advertisements is
appropriate for inclusion in such television advertisements.
(2) Content.--As part of the study under paragraph (1),
such Secretary shall consider whether the information in the
statement described in paragraph (1) would detract from the
presentation of risk information in a direct-to-consumer
television advertisement. If such Secretary determines the
inclusion of such statement is appropriate in direct-to-
consumer television advertisements, such Secretary shall
issue regulations requiring the implementation of such
statement in direct-to-consumer television advertisements,
including determining a reasonable length of time for
displaying the statement in such advertisements. The
Secretary shall report to the appropriate committees of
Congress the findings of such study and any plans to issue
regulations under this paragraph.
SEC. 907. NO EFFECT ON VETERINARY MEDICINE.
This subtitle, and the amendments made by this subtitle,
shall have no effect on the use of drugs approved under
section 505 of the Federal Food, Drug, and Cosmetic Act by,
or on the lawful written or oral order of, a licensed
veterinarian within the context of a veterinarian-client-
patient relationship, as provided for under section 512(a)(5)
of such Act.
SEC. 908. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--For carrying out this subtitle and the
amendments made by this subtitle, 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 subtitle and the
amendments made by this subtitle.
SEC. 909. EFFECTIVE DATE AND APPLICABILITY.
(a) Effective Date.--This subtitle 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) (referred to
in this section as the ``Act'') if there are in effect on the
effective date of this Act elements to assure safe 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 timetable required under
section 505-1(d) and any additional elements under
subsections (e) and (f) 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, except that sections
303(f)(4) and 502(y) and (z) of the Act (as added by section
902) shall not apply to such strategy before the Secretary
has completed review of, and acted on, the first assessment
of such strategy under such section 505-1.
(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
[[Page H10587]]
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.
Subtitle B--Other Provisions to Ensure Drug Safety and Surveillance
SEC. 911. 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
the enactment of this section, the Secretary 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 guidance
shall indicate the appropriate models and valid surrogate
markers.
``(b) Review.--Not later than 5 years after the date of the
enactment of this section, the Secretary shall review and
update the guidance described under subsection (a) to reflect
developments in scientific and medical information and
technology.''.
SEC. 912. PROHIBITION AGAINST FOOD TO WHICH DRUGS OR
BIOLOGICAL PRODUCTS HAVE BEEN ADDED.
(a) Prohibition.--Section 301 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331), as amended by section
901(d), is amended by adding at the end the following:
``(ll) The introduction or delivery for introduction into
interstate commerce of any food to which has been added a
drug approved under section 505, a biological product
licensed under section 351 of the Public Health Service Act,
or a drug or a biological product for which substantial
clinical investigations have been instituted and for which
the existence of such investigations has been made public,
unless--
``(1) such drug or such biological product was marketed in
food before any approval of the drug under section 505,
before licensure of the biological product under such section
351, and before any substantial clinical investigations
involving the drug or the biological product have been
instituted;
``(2) the Secretary, in the Secretary's discretion, has
issued a regulation, after notice and comment, approving the
use of such drug or such biological product in the food;
``(3) the use of the drug or the biological product in the
food is to enhance the safety of the food to which the drug
or the biological product is added or applied and not to have
independent biological or therapeutic effects on humans, and
the use is in conformity with--
``(A) a regulation issued under section 409 prescribing
conditions of safe use in food;
``(B) a regulation listing or affirming conditions under
which the use of the drug or the biological product in food
is generally recognized as safe;
``(C) the conditions of use identified in a notification to
the Secretary of a claim of exemption from the premarket
approval requirements for food additives based on the
notifier's determination that the use of the drug or the
biological product in food is generally recognized as safe,
provided that the Secretary has not questioned the general
recognition of safety determination in a letter to the
notifier;
``(D) a food contact substance notification that is
effective under section 409(h); or
``(E) such drug or biological product had been marketed for
smoking cessation prior to the date of the enactment of the
Food and Drug Administration Amendments Act of 2007; or
``(4) the drug is a new animal drug whose use is not unsafe
under section 512.''.
(b) Conforming Changes.--The Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
(1) in section 304(a)(1), by striking ``section 404 or
505'' and inserting ``section 301(ll), 404, or 505''; and
(2) in section 801(a), by striking ``is adulterated,
misbranded, or in violation of section 505,'' and inserting
``is adulterated, misbranded, or in violation of section 505,
or prohibited from introduction or delivery for introduction
into interstate commerce under section 301(ll),''.
SEC. 913. ASSURING PHARMACEUTICAL SAFETY.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.), as amended in section 403, is amended by
inserting after section 505C the following:
``SEC. 505D. PHARMACEUTICAL SECURITY.
``(a) In General.--The Secretary shall develop standards
and identify and validate effective technologies for the
purpose of securing the drug supply chain 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 (4), manufacturers,
distributors, pharmacies, and other supply chain
stakeholders, prioritize and develop standards for the
identification, validation, authentication, and tracking and
tracing of prescription drugs.
``(2) Standardized numeral identifier.--Not later than 30
months after the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, the Secretary shall
develop a standardized numerical identifier (which, to the
extent practicable, shall be harmonized with international
consensus standards for such an identifier) to be applied to
a prescription drug at the point of manufacturing and
repackaging (in which case the numerical identifier shall be
linked to the numerical identifier applied at the point of
manufacturing) at the package or pallet level, sufficient to
facilitate the identification, validation, authentication,
and tracking and tracing of the prescription drug.
``(3) Promising technologies.--The standards developed
under this subsection shall address promising technologies,
which may include--
``(A) radio frequency identification technology;
``(B) nanotechnology;
``(C) encryption technologies; and
``(D) other track-and-trace or authentication technologies.
``(4) Interagency collaboration.--In carrying out this
subsection, the Secretary shall consult with Federal health
and security agencies, including--
``(A) the Department of Justice;
``(B) the Department of Homeland Security;
``(C) the Department 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 agency components of the Food
and Drug Administration involved with regulatory and criminal
enforcement of this Act to secure the drug supply chain
against counterfeit, diverted, subpotent, substandard,
adulterated, misbranded, or expired drugs including
biological products and active pharmaceutical ingredients
from domestic and foreign sources.
``(2) Activities.--The Secretary shall undertake enhanced
and joint enforcement activities with other Federal and State
agencies, and establish regional capacities for the
validation of prescription drugs and the inspection of the
prescription drug supply chain.
``(d) Definition.--In this section, the term `prescription
drug' means a drug subject to section 503(b)(1).''.
SEC. 914. 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.--
``(A) Determination.--The Secretary shall not delay
approval of a pending application submitted under subsection
(b)(2) or (j) because of any request to take any form of
action relating to the application, either before or during
consideration of the request, unless--
``(i) the request is in writing and is a petition submitted
to the Secretary pursuant to section 10.30 or 10.35 of title
21, Code of Federal Regulations (or any successor
regulations); and
``(ii) the Secretary determines, upon reviewing the
petition, that a delay is necessary to protect the public
health.
``(B) Notification.--If the Secretary determines under
subparagraph (A) that a delay is necessary with respect to an
application, the Secretary shall provide to the applicant,
not later than 30 days after making such determination, the
following information:
``(i) Notification of the fact that a determination under
subparagraph (A) has been made.
``(ii) If applicable, any clarification or additional data
that the applicant should submit to the docket on the
petition to allow the Secretary to review the petition
promptly.
``(iii) A brief summary of the specific substantive issues
raised in the petition which form the basis of the
determination.
``(C) Format.--The information described in subparagraph
(B) shall be conveyed via either, at the discretion of the
Secretary--
``(i) a document; or
``(ii) a meeting with the applicant involved.
``(D) Public disclosure.--Any information conveyed by the
Secretary under subparagraph (C) shall be considered part of
the application and shall be subject to the disclosure
requirements applicable to information in such application.
``(E) Denial based on intent to delay.--If the Secretary
determines that a petition or a supplement to the petition
was submitted with the primary purpose of delaying the
approval of an application and the petition does not on its
face raise valid scientific or regulatory issues, the
Secretary may deny the petition at any point based on such
determination. The Secretary may issue guidance to describe
the factors that will be used to determine under this
subparagraph whether a petition is submitted with the primary
purpose of delaying the approval of an application.
``(F) Final agency action.--The Secretary shall take final
agency action on a petition not later than 180 days after the
date on which the petition is submitted. The Secretary shall
not extend such period for any reason, including--
``(i) any determination made under subparagraph (A);
``(ii) the submission of comments relating to the petition
or supplemental information supplied by the petitioner; or
[[Page H10588]]
``(iii) the consent of the petitioner.
``(G) Extension of 30-month period.--If the filing of an
application resulted in first-applicant status under
subsection (j)(5)(D)(i)(IV) and approval of the application
was delayed because of a petition, 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.
``(H) Certification.--The Secretary shall not consider a
petition for review unless the party submitting such petition
does so in written form and the subject document 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: __________. If I received or expect to
receive payments, including cash and other forms of
consideration, to file this information or its contents, I
received or expect to receive those payments from the
following persons or organizations: _____________. I verify
under penalty of perjury that the foregoing is true and
correct as of the date of the submission of this petition.',
with the date on which such information first became known to
such party and the names of such persons or organizations
inserted in the first and second blank space, respectively.
``(I) Verification.--The Secretary shall not accept for
review any supplemental information or comments on a petition
unless the party submitting such information or comments does
so in written form and the subject document is signed and
contains the following verification: `I certify that, to my
best knowledge and belief: (a) I have not intentionally
delayed submission of this document or its contents; and (b)
the information upon which I have based the action requested
herein first became known to me on or about __________. If I
received or expect to receive payments, including cash and
other forms of consideration, to file this information or its
contents, I received or expect to receive those payments from
the following persons or organizations: _____. I verify under
penalty of perjury that the foregoing is true and correct as
of the date of the submission of this petition.', with the
date on which such information first became known to the
party and the names of such persons or organizations inserted
in the first and second blank space, respectively.
``(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 if--
``(i) during the 180-day period referred to in paragraph
(1)(F), 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 against the Secretary with respect to any
issue raised in the petition before the Secretary has taken
final agency action on the petition within the meaning of
subparagraph (A), the court shall dismiss without prejudice
the action for failure to exhaust administrative remedies.
``(C) Administrative record.--For purposes of judicial
review related to the approval of an application for which a
petition under paragraph (1) was submitted, the
administrative record regarding any issue raised by the
petition shall include--
``(i) the petition filed under paragraph (1) and any
supplements and comments thereto;
``(ii) the Secretary's response to such petition, if
issued; and
``(iii) other information, as designated by the Secretary,
related to the Secretary's determinations regarding the
issues raised in such petition, as long as the information
was considered by the agency no later than the date of final
agency action as defined under subparagraph (2)(A), and
regardless of whether the Secretary responded to the petition
at or before the approval of the application at issue in the
petition.
``(3) 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 that were approved during
the preceding 12-month period;
``(B) the number of such applications whose effective dates
were delayed by petitions referred to in paragraph (1) during
such period;
``(C) the number of days by which such applications were so
delayed; and
``(D) the number of such petitions that were submitted
during such period.
``(4) 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 and that seeks only to have the Secretary take or
refrain from taking any form of action with respect to that
application.
``(5) Definitions.--
``(A) Application.--For purposes of this subsection, the
term `application' means an application submitted under
subsection (b)(2) or (j).
``(B) Petition.--For purposes of this subsection, other
than paragraph (1)(A)(i), the term `petition' means a request
described in paragraph (1)(A)(i).''.
(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. 915. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND
PROVIDERS.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as amended by section 914(a), is amended by
adding at the end the following:
``(r) Postmarket Drug Safety Information for Patients and
Providers.--
``(1) Establishment.--Not later than 1 year after the date
of the enactment of the Food and Drug Administration
Amendments Act of 2007, the Secretary shall improve the
transparency of information about drugs and allow patients
and health care providers better access to information about
drugs by developing and maintaining an Internet Web site
that--
``(A) provides links to drug safety information listed in
paragraph (2) for prescription drugs that are approved under
this section or licensed under section 351 of the Public
Health Service Act; and
``(B) improves communication of drug safety information to
patients and providers.
``(2) Internet web site.--The Secretary shall carry out
paragraph (1) by--
``(A) developing and maintaining an accessible,
consolidated Internet Web site with easily searchable drug
safety information, including the information found on United
States Government Internet Web sites, such as the United
States National Library of Medicine's Daily Med and Medline
Plus Web sites, in addition to other such Web sites
maintained by the Secretary;
``(B) ensuring that the information provided on the
Internet Web site is comprehensive and includes, when
available and appropriate--
``(i) patient labeling and patient packaging inserts;
``(ii) a link to a list of each drug, whether approved
under this section or licensed under such section 351, for
which a Medication Guide, as provided for under part 208 of
title 21, Code of Federal Regulations (or any successor
regulations), is required;
``(iii) a link to the registry and results data bank
provided for under subsections (i) and (j) of section 402 of
the Public Health Service Act;
``(iv) the most recent safety information and alerts issued
by the Food and Drug Administration for drugs approved by the
Secretary under this section, such as product recalls,
warning letters, and import alerts;
``(v) publicly available information about implemented
RiskMAPs and risk evaluation and mitigation strategies under
subsection (o);
``(vi) guidance documents and regulations related to drug
safety; and
``(vii) other material determined appropriate by the
Secretary;
``(C) providing access to summaries of the assessed and
aggregated data collected from the active surveillance
infrastructure under subsection (k)(3) to provide information
of known and serious side-effects for drugs approved under
this section or licensed under such section 351;
``(D) preparing, by 18 months after approval of a drug or
after use of the drug by 10,000 individuals, whichever is
later, a summary analysis of the adverse drug reaction
reports received for the drug, including identification of
any new risks not previously identified, potential new risks,
or known risks reported in unusual number;
``(E) enabling patients, providers, and drug sponsors to
submit adverse event reports through the Internet Web site;
``(F) providing educational materials for patients and
providers about the appropriate means of disposing of
expired, damaged, or unusable medications; and
``(G) supporting initiatives that the Secretary determines
to be useful to fulfill the purposes of the Internet Web
site.
``(3) Posting of drug labeling.--The Secretary shall post
on the Internet Web site established under paragraph (1) the
approved professional labeling and any required patient
labeling of a drug approved under this section or licensed
under such section 351 not later than 21 days after the date
the drug is approved or licensed, including in a supplemental
application with respect to a labeling change.
``(4) Private sector resources.--To ensure development of
the Internet Web site by the date described in paragraph (1),
the Secretary may, on a temporary or permanent basis,
implement systems or products developed by private entities.
``(5) Authority for contracts.--The Secretary may enter
into contracts with public
[[Page H10589]]
and private entities to fulfill the requirements of this
subsection.
``(6) Review.--The Advisory Committee on Risk Communication
under section 567 shall, on a regular basis, perform a
comprehensive review and evaluation of the types of risk
communication information provided on the Internet Web site
established under paragraph (1) and, through other means,
shall identify, clarify, and define the purposes and types of
information available to facilitate the efficient flow of
information to patients and providers, and shall recommend
ways for the Food and Drug Administration to work with
outside entities to help facilitate the dispensing of risk
communication information to patients and providers.''.
SEC. 916. ACTION PACKAGE FOR APPROVAL.
Section 505(l) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(l)) is amended by--
(1) redesignating paragraphs (1), (2), (3), (4), and (5) as
subparagraphs (A), (B), (C), (D), and (E), respectively;
(2) striking ``(l) Safety and'' and inserting ``(l)(1)
Safety and''; and
(3) adding at the end the following:
``(2) Action package for approval.--
``(A) Action package.--The Secretary shall publish the
action package for approval of an application under
subsection (b) or section 351 of the Public Health Service
Act on the Internet Web site of the Food and Drug
Administration--
``(i) not later than 30 days after the date of approval of
such application for a drug no active ingredient (including
any ester or salt of the active ingredient) of which has been
approved in any other application under this section or
section 351 of the Public Health Service Act; and
``(ii) not later than 30 days after the third request for
such action package for approval received under section 552
of title 5, United States Code, for any other drug.
``(B) Immediate publication of summary review.--
Notwithstanding subparagraph (A), the Secretary shall
publish, on the Internet Web site of the Food and Drug
Administration, the materials described in subparagraph
(C)(iv) not later than 48 hours after the date of approval of
the drug, except where such materials require redaction by
the Secretary.
``(C) Contents.--An action package for approval of an
application under subparagraph (A) shall be dated and shall
include the following:
``(i) Documents generated by the Food and Drug
Administration related to review of the application.
``(ii) Documents pertaining to the format and content of
the application generated during drug development.
``(iii) Labeling submitted by the applicant.
``(iv) A summary review that documents conclusions from all
reviewing disciplines about the drug, noting any critical
issues and disagreements with the applicant and within the
review team and how they were resolved, recommendations for
action, and an explanation of any nonconcurrence with review
conclusions.
``(v) The Division Director and Office Director's decision
document which includes--
``(I) a brief statement of concurrence with the summary
review;
``(II) a separate review or addendum to the review if
disagreeing with the summary review; and
``(III) a separate review or addendum to the review to add
further analysis.
``(vi) Identification by name of each officer or employee
of the Food and Drug Administration who--
``(I) participated in the decision to approve the
application; and
``(II) consents to have his or her name included in the
package.
``(D) Review.--A scientific review of an application is
considered the work of the reviewer and shall not be altered
by management or the reviewer once final.
``(E) Confidential information.--This paragraph does not
authorize the disclosure of any trade secret, confidential
commercial or financial information, or other matter listed
in section 552(b) of title 5, United States Code.''.
SEC. 917. RISK COMMUNICATION.
Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.), as amended by
section 603, is amended by adding at the end the following:
``SEC. 567. RISK COMMUNICATION.
``(a) Advisory Committee on Risk Communication.--
``(1) In general.--The Secretary shall establish an
advisory committee to be known as the `Advisory Committee on
Risk Communication' (referred to in this section as the
`Committee').
``(2) Duties of committee.--The Committee shall advise the
Commissioner on methods to effectively communicate risks
associated with the products regulated by the Food and Drug
Administration.
``(3) Members.--The Secretary shall ensure that the
Committee is composed of experts on risk communication,
experts on the risks described in subsection (b), and
representatives of patient, consumer, and health professional
organizations.
``(4) Permanence of committee.--Section 14 of the Federal
Advisory Committee Act shall not apply to the Committee
established under this subsection.
``(b) Partnerships for Risk Communication.--
``(1) In general.--The Secretary shall partner with
professional medical societies, medical schools, academic
medical centers, and other stakeholders to develop robust and
multi-faceted systems for communication to health care
providers about emerging postmarket drug risks.
``(2) Partnerships.--The systems developed under paragraph
(1) shall--
``(A) account for the diversity among physicians in terms
of practice, willingness to adopt technology, and medical
specialty; and
``(B) include the use of existing communication channels,
including electronic communications, in place at the Food and
Drug Administration.''.
SEC. 918. REFERRAL TO ADVISORY COMMITTEE.
Section 505 of the Federal Food, Drug, and Cosmetic Act, as
amended by section 915, is further amended by adding at the
end the following:
``(s) Referral to Advisory Committee.--Prior to the
approval of a drug no active ingredient (including any ester
or salt of the active ingredient) of which has been approved
in any other application under this section or section 351 of
the Public Health Service Act, the Secretary shall--
``(1) refer such drug to a Food and Drug Administration
advisory committee for review at a meeting of such advisory
committee; or
``(2) if the Secretary does not refer such a drug to a Food
and Drug Administration advisory committee prior to the
approval of the drug, provide in the action letter on the
application for the drug a summary of the reasons why the
Secretary did not refer the drug to an advisory committee
prior to approval.''.
SEC. 919. RESPONSE TO THE INSTITUTE OF MEDICINE.
(a) In General.--Not later than 1 year after the date of
the enactment of this title, the Secretary shall issue a
report responding to the 2006 report of the Institute of
Medicine entitled ``The Future of Drug Safety--Promoting and
Protecting the Health of the Public''.
(b) Content of Report.--The report issued by the Secretary
under subsection (a) shall include--
(1) an update on the implementation by the Food and Drug
Administration of its plan to respond to the Institute of
Medicine report described under such subsection; and
(2) an assessment of how the Food and Drug Administration
has implemented--
(A) the recommendations described in such Institute of
Medicine report; and
(B) the requirement under section 505-1(c)(2) of the
Federal Food, Drug, and Cosmetic Act (as added by this
title), that the appropriate office responsible for reviewing
a drug and the office responsible for postapproval safety
with respect to the drug work together to assess, implement,
and ensure compliance with the requirements of such section
505-1.
SEC. 920. DATABASE FOR AUTHORIZED GENERIC DRUGS.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as amended by section 918, is further amended by
adding at the end the following:
``(t) Database for Authorized Generic Drugs.--
``(1) In general.--
``(A) Publication.--The Commissioner shall--
``(i) not later than 9 months after the date of the
enactment of the Food and Drug Administration Amendments Act
of 2007, publish a complete list on the Internet Web site of
the Food and Drug Administration of all authorized generic
drugs (including drug trade name, brand company manufacturer,
and the date the authorized generic drug entered the market);
and
``(ii) update the list quarterly to include each authorized
generic drug included in an annual report submitted to the
Secretary by the sponsor of a listed drug during the
preceding 3-month period.
``(B) Notification.--The Commissioner shall notify relevant
Federal agencies, including the Centers for Medicare &
Medicaid Services and the Federal Trade Commission, when the
Commissioner first publishes the information described in
subparagraph (A) that the information has been published and
that the information will be updated quarterly.
``(2) Inclusion.--The Commissioner shall include in the
list described in paragraph (1) each authorized generic drug
included in an annual report submitted to the Secretary by
the sponsor of a listed drug after January 1, 1999.
``(3) Authorized generic drug.--In this section, the term
`authorized generic drug' means a listed drug (as that term
is used in subsection (j)) that--
``(A) has been approved under subsection (c); and
``(B) is marketed, sold, or distributed directly or
indirectly to retail class of trade under a different
labeling, packaging (other than repackaging as the listed
drug in blister packs, unit doses, or similar packaging for
use in institutions), product code, labeler code, trade name,
or trade mark than the listed drug.''.
SEC. 921. ADVERSE DRUG REACTION REPORTS AND POSTMARKET
SAFETY.
Subsection (k) of section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355), as amended by section 905,
is amended by adding at the end the following:
``(5) The Secretary shall--
``(A) conduct regular, bi-weekly screening of the Adverse
Event Reporting System database and post a quarterly report
on the
[[Page H10590]]
Adverse Event Reporting System Web site of any new safety
information or potential signal of a serious risk identified
by Adverse Event Reporting System within the last quarter;
``(B) report to Congress not later than 2 year after the
date of the enactment of the Food and Drug Administration
Amendments Act of 2007 on procedures and processes of the
Food and Drug Administration for addressing ongoing post
market safety issues identified by the Office of Surveillance
and Epidemiology and how recommendations of the Office of
Surveillance and Epidemiology are handled within the agency;
and
``(C) on an annual basis, review the entire backlog of
postmarket safety commitments to determine which commitments
require revision or should be eliminated, report to the
Congress on these determinations, and assign start dates and
estimated completion dates for such commitments.''.
TITLE X--FOOD SAFETY
SEC. 1001. FINDINGS.
Congress finds that--
(1) the safety and integrity of the United States food
supply are vital to public health, to public confidence in
the food supply, and to the success of the food sector of the
Nation's economy;
(2) illnesses and deaths of individuals and companion
animals caused by contaminated food--
(A) have contributed to a loss of public confidence in food
safety; and
(B) have caused significant economic losses to
manufacturers and producers not responsible for contaminated
food items;
(3) the task of preserving the safety of the food supply of
the United States faces tremendous pressures with regard to--
(A) emerging pathogens and other contaminants and the
ability to detect all forms of contamination;
(B) an increasing volume of imported food from a wide
variety of countries; and
(C) a shortage of adequate resources for monitoring and
inspection;
(4) according to the Economic Research Service of the
Department of Agriculture, the United States is increasing
the amount of food that it imports such that--
(A) from 2003 to 2007, the value of food imports has
increased from $45,600,000,000 to $64,000,000,000; and
(B) imported food accounts for 13 percent of the average
American diet including 31 percent of fruits, juices, and
nuts, 9.5 percent of red meat, and 78.6 percent of fish and
shellfish; and
(5) the number of full-time equivalent Food and Drug
Administration employees conducting inspections has decreased
from 2003 to 2007.
SEC. 1002. ENSURING THE SAFETY OF PET FOOD.
(a) Processing and Ingredient Standards.--Not later than 2
years after the date of the enactment of this Act, the
Secretary of Health and Human Services (referred to in this
title as the ``Secretary''), in consultation with the
Association of American Feed Control Officials and other
relevant stakeholder groups, including veterinary medical
associations, animal health organizations, and pet food
manufacturers, shall by regulation establish--
(1) ingredient standards and definitions with respect to
pet food;
(2) processing standards for pet food; and
(3) updated standards for the labeling of pet food that
include nutritional and ingredient information.
(b) Early Warning Surveillance Systems and Notification
During Pet Food Recalls.--Not later than 1 year after the
date of the enactment of this Act, the Secretary shall
establish an early warning and surveillance system to
identify adulteration of the pet food supply and outbreaks of
illness associated with pet food. In establishing such
system, the Secretary shall--
(1) consider using surveillance and monitoring mechanisms
similar to, or in coordination with, those used to monitor
human or animal health, such as the Foodborne Diseases Active
Surveillance Network (FoodNet) and PulseNet of the Centers
for Disease Control and Prevention, the Food Emergency
Response Network of the Food and Drug Administration and the
Department of Agriculture, and the National Animal Health
Laboratory Network of the Department of Agriculture;
(2) consult with relevant professional associations and
private sector veterinary hospitals;
(3) work with the National Companion Animal Surveillance
Program, the Health Alert Network, or other notification
networks as appropriate to inform veterinarians and relevant
stakeholders during any recall of pet food; and
(4) use such information and conduct such other activities
as the Secretary deems appropriate.
SEC. 1003. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS
DURING A RECALL.
The Secretary shall, during an ongoing recall of human or
pet food regulated by the Secretary--
(1) work with companies, relevant professional
associations, and other organizations to collect and
aggregate information pertaining to the recall;
(2) use existing networks of communication, including
electronic forms of information dissemination, to enhance the
quality and speed of communication with the public; and
(3) post information regarding recalled human and pet foods
on the Internet Web site of the Food and Drug Administration
in a single location, which shall include a searchable
database of recalled human foods and a searchable database of
recalled pet foods, that is easily accessed and understood by
the public.
SEC. 1004. STATE AND FEDERAL COOPERATION.
(a) In General.--The Secretary shall work with the States
in undertaking activities and programs that assist in
improving the safety of food, including fresh and processed
produce, so that State food safety programs and activities
conducted by the Secretary function in a coordinated and
cost-effective manner. With the assistance provided under
subsection (b), the Secretary shall encourage States to--
(1) establish, continue, or strengthen State food safety
programs, especially with respect to the regulation of retail
commercial food establishments; and
(2) establish procedures and requirements for ensuring that
processed produce under the jurisdiction of State food safety
programs is not unsafe for human consumption.
(b) Assistance.--The Secretary may provide to a State, for
planning, developing, and implementing such a food safety
program--
(1) advisory assistance;
(2) technical assistance, training, and laboratory
assistance (including necessary materials and equipment); and
(3) financial and other assistance.
(c) Service Agreements.--The Secretary may, under an
agreement entered into with a Federal, State, or local
agency, use, on a reimbursable basis or otherwise, the
personnel, services, and facilities of the agency to carry
out the responsibilities of the agency under this section. An
agreement entered into with a State agency under this
subsection may provide for training of State employees.
SEC. 1005. REPORTABLE FOOD REGISTRY.
(a) Findings.--Congress makes the following findings:
(1) In 1994, Congress passed the Dietary Supplement Health
and Education Act of 1994 (Public Law 103-417) to provide the
Food and Drug Administration the legal framework which is
intended to ensure that dietary supplements are safe and
properly labeled foods.
(2) In 2006, Congress passed the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (Public Law 109-
462) to establish a mandatory reporting system of serious
adverse events for nonprescription drugs and dietary
supplements sold and consumed in the United States.
(3) The adverse event reporting system created under the
Dietary Supplement and Nonprescription Drug Consumer
Protection Act is intended to serve as an early warning
system for potential public health issues associated with the
use of these products.
(4) A reliable mechanism to track patterns of adulteration
in food would support efforts by the Food and Drug
Administration to target limited inspection resources to
protect the public health.
(b) In General.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at
the end the following:
``SEC. 417. REPORTABLE FOOD REGISTRY.
``(a) Definitions.--In this section:
``(1) Responsible party.--The term `responsible party',
with respect to an article of food, means a person that
submits the registration under section 415(a) for a food
facility that is required to register under section 415(a),
at which such article of food is manufactured, processed,
packed, or held.
``(2) Reportable food.--The term `reportable food' means an
article of food (other than infant formula) for which there
is a reasonable probability that the use of, or exposure to,
such article of food will cause serious adverse health
consequences or death to humans or animals.
``(b) Establishment.--
``(1) In general.--Not later than 1 year after the date of
the enactment of this section, the Secretary shall establish
within the Food and Drug Administration a Reportable Food
Registry to which instances of reportable food may be
submitted by the Food and Drug Administration after receipt
of reports under subsection (d), via an electronic portal,
from--
``(A) Federal, State, and local public health officials; or
``(B) responsible parties.
``(2) Review by secretary.--The Secretary shall promptly
review and assess the information submitted under paragraph
(1) for the purposes of identifying reportable food,
submitting entries to the Reportable Food Registry, acting
under subsection (c), and exercising other existing food
safety authorities under this Act to protect the public
health.
``(c) Issuance of an Alert by the Secretary.--
``(1) In general.--The Secretary shall issue, or cause to
be issued, an alert or a notification with respect to a
reportable food using information from the Reportable Food
Registry as the Secretary deems necessary to protect the
public health.
``(2) Effect.--Paragraph (1) shall not affect the authority
of the Secretary to issue an alert or a notification under
any other provision of this Act.
``(d) Reporting and Notification.--
``(1) In general.--Except as provided in paragraph (2), as
soon as practicable, but in no case later than 24 hours after
a responsible party determines that an article of food
[[Page H10591]]
is a reportable food, the responsible party shall--
``(A) submit a report to the Food and Drug Administration
through the electronic portal established under subsection
(b) that includes the data elements described in subsection
(e) (except the elements described in paragraphs (8), (9),
and (10) of such subsection); and
``(B) investigate the cause of the adulteration if the
adulteration of the article of food may have originated with
the responsible party.
``(2) No report required.--A responsible party is not
required to submit a report under paragraph (1) if--
``(A) the adulteration originated with the responsible
party;
``(B) the responsible party detected the adulteration prior
to any transfer to another person of such article of food;
and
``(C) the responsible party--
``(i) corrected such adulteration; or
``(ii) destroyed or caused the destruction of such article
of food.
``(3) Reports by public health officials.--A Federal,
State, or local public health official may submit a report
about a reportable food to the Food and Drug Administration
through the electronic portal established under subsection
(b) that includes the data elements described in subsection
(e) that the official is able to provide.
``(4) Report number.--The Secretary shall ensure that, upon
submission of a report under paragraph (1) or (3), a unique
number is issued through the electronic portal established
under subsection (b) to the person submitting such report, by
which the Secretary is able to link reports about the
reportable food submitted and amended under this subsection
and identify the supply chain for such reportable food.
``(5) Review.--The Secretary shall promptly review a report
submitted under paragraph (1) or (3).
``(6) Response to report submitted by a responsible
party.--After consultation with the responsible party that
submitted a report under paragraph (1), the Secretary may
require such responsible party to perform, as soon as
practicable, but in no case later than a time specified by
the Secretary, 1 or more of the following:
``(A) Amend the report submitted by the responsible party
under paragraph (1) to include the data element described in
subsection (e)(9).
``(B) Provide a notification--
``(i) to the immediate previous source of the article of
food, if the Secretary deems necessary;
``(ii) to the immediate subsequent recipient of the article
of food, if the Secretary deems necessary; and
``(iii) that includes--
``(I) the data elements described in subsection (e) that
the Secretary deems necessary;
``(II) the actions described under paragraph (7) that the
recipient of the notification shall perform, as required by
the Secretary; and
``(III) any other information that the Secretary may
require.
``(7) Subsequent reports and notifications.--Except as
provided in paragraph (8), the Secretary may require a
responsible party to perform, as soon as practicable, but in
no case later than a time specified by the Secretary, after
the responsible party receives a notification under
subparagraph (C) or paragraph (6)(B), 1 or more of the
following:
``(A) Submit a report to the Food and Drug Administration
through the electronic portal established under subsection
(b) that includes those data elements described in subsection
(e) and other information that the Secretary deems necessary.
``(B) Investigate the cause of the adulteration if the
adulteration of the article of food may have originated with
the responsible party.
``(C) Provide a notification--
``(i) to the immediate previous source of the article of
food, if the Secretary deems necessary;
``(ii) to the immediate subsequent recipient of the article
of food, if the Secretary deems necessary; and
``(iii) that includes--
``(I) the data elements described in subsection (e) that
the Secretary deems necessary;
``(II) the actions described under this paragraph that the
recipient of the notification shall perform, as required by
the Secretary; and
``(III) any other information that the Secretary may
require.
``(8) Amended report.--If a responsible party receives a
notification under paragraph (6)(B) or paragraph (7)(C) with
respect to an article of food after the responsible party has
submitted a report to the Food and Drug Administration under
paragraph (1) with respect to such article of food--
``(A) the responsible party is not required to submit an
additional report or make a notification under paragraph (7);
and
``(B) the responsible party shall amend the report
submitted by the responsible party under paragraph (1) to
include the data elements described in paragraph (9), and,
with respect to both such notification and such report,
paragraph (11) of subsection (e).
``(e) Data Elements.--The data elements described in this
subsection are the following:
``(1) The registration numbers of the responsible party
under section 415(a)(3).
``(2) The date on which an article of food was determined
to be a reportable food.
``(3) A description of the article of food including the
quantity or amount.
``(4) The extent and nature of the adulteration.
``(5) If the adulteration of the article of food may have
originated with the responsible party, the results of the
investigation required under paragraph (1)(B) or (7)(B) of
subsection (d), as applicable and when known.
``(6) The disposition of the article of food, when known.
``(7) Product information typically found on packaging
including product codes, use-by dates, and names of
manufacturers, packers, or distributors sufficient to
identify the article of food.
``(8) Contact information for the responsible party.
``(9) The contact information for parties directly linked
in the supply chain and notified under paragraph (6)(B) or
(7)(C) of subsection (d), as applicable.
``(10) The information required by the Secretary to be
included in a notification provided by the responsible party
involved under paragraph (6)(B) or (7)(C) of subsection (d)
or required in a report under subsection (d)(7)(A).
``(11) The unique number described in subsection (d)(4).
``(f) Coordination of Federal, State, and Local Efforts.--
``(1) Department of agriculture.--In implementing this
section, the Secretary shall--
``(A) share information and coordinate regulatory efforts
with the Department of Agriculture; and
``(B) if the Secretary receives a report submitted about a
food within the jurisdiction of the Department of
Agriculture, promptly provide such report to the Department
of Agriculture.
``(2) States and localities.--In implementing this section,
the Secretary shall work with the State and local public
health officials to share information and coordinate
regulatory efforts, in order to--
``(A) help to ensure coverage of the safety of the food
supply chain, including those food establishments regulated
by the States and localities that are not required to
register under section 415; and
``(B) reduce duplicative regulatory efforts.
``(g) Maintenance and Inspection of Records.--The
responsible party shall maintain records related to each
report received, notification made, and report submitted to
the Food and Drug Administration under this section for 2
years. A responsible party shall, at the request of the
Secretary, permit inspection of such records as provided for
section 414.
``(h) Request for Information.--Except as provided by
section 415(a)(4), section 552 of title 5, United States
Code, shall apply to any request for information regarding a
record in the Reportable Food Registry.
``(i) Safety Report.--A report or notification under
subsection (d) shall be considered to be a safety report
under section 756 and may be accompanied by a statement,
which shall be part of any report released for public
disclosure, that denies that the report or the notification
constitutes an admission that the product involved caused or
contributed to a death, serious injury, or serious illness.
``(j) Admission.--A report or notification under this
section shall not be considered an admission that the article
of food involved is adulterated or caused or contributed to a
death, serious injury, or serious illness.
``(k) Homeland Security Notification.--If, after receiving
a report under subsection (d), the Secretary believes such
food may have been deliberately adulterated, the Secretary
shall immediately notify the Secretary of Homeland Security.
The Secretary shall make relevant information from the
Reportable Food Registry available to the Secretary of
Homeland Security.''.
(c) Definition.--Section 201(ff) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321(ff)) is amended by striking
``section 201(g)'' and inserting ``sections 201(g) and 417''.
(d) Prohibited Acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section
912, is further amended--
(1) in subsection (e), by--
(A) striking ``414,'' and inserting ``414, 417(g),''; and
(B) striking ``414(b)'' and inserting ``414(b), 417''; and
(2) by adding at the end the following:
``(mm) The failure to submit a report or provide a
notification required under section 417(d).
``(nn) The falsification of a report or notification
required under section 417(d).''.
(e) Effective Date.--The requirements of section 417(d) of
the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), shall become effective 1 year after the date
of the enactment of this Act.
(f) Guidance.--Not later than 9 months after the date of
the enactment of this Act, the Secretary shall issue a
guidance to industry about submitting reports to the
electronic portal established under section 417 of the
Federal Food, Drug, and Cosmetic Act (as added by this
section) and providing notifications to other persons in the
supply chain of an article of food under such section 417.
(g) Effect.--Nothing in this title, or an amendment made by
this title, shall be construed to alter the jurisdiction
between the
[[Page H10592]]
Secretaries of Agriculture and of Health and Human Services,
under applicable statutes and regulations.
SEC. 1006. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION.
(a) Findings.--Congress finds the following:
(1) In 2007, there has been an overwhelming increase in the
volume of aquaculture and seafood that has been found to
contain substances that are not approved for use in food in
the United States.
(2) As of May 2007, inspection programs are not able to
satisfactorily accomplish the goals of ensuring the food
safety of the United States.
(3) To protect the health and safety of consumers in the
United States, the ability of the Secretary to perform
inspection functions must be enhanced.
(b) Heightened Inspections.--The Secretary is authorized to
enhance, as necessary, the inspection regime of the Food and
Drug Administration for aquaculture and seafood, consistent
with obligations of the United States under international
agreements and United States law.
(c) Report to Congress.--Not later than 180 days after the
date of the enactment of this Act, the Secretary shall submit
to Congress a report that--
(1) describes the specifics of the aquaculture and seafood
inspection program;
(2) describes the feasibility of developing a traceability
system for all catfish and seafood products, both domestic
and imported, for the purpose of identifying the processing
plant of origin of such products; and
(3) provides for an assessment of the risks associated with
particular contaminants and banned substances.
(d) Partnerships With States.--Upon the request by any
State, the Secretary may enter into partnership agreements,
as soon as practicable after the request is made, to
implement inspection programs to Federal standards regarding
the importation of aquaculture and seafood.
SEC. 1007. CONSULTATION REGARDING GENETICALLY ENGINEERED
SEAFOOD PRODUCTS.
The Commissioner of Food and Drugs shall consult with the
Assistant Administrator of the National Marine Fisheries
Service of the National Oceanic and Atmospheric
Administration to produce a report on any environmental risks
associated with genetically engineered seafood products,
including the impact on wild fish stocks.
SEC. 1008. SENSE OF CONGRESS.
It is the sense of Congress that--
(1) it is vital for Congress to provide the Food and Drug
Administration with additional resources, authorities, and
direction with respect to ensuring the safety of the food
supply of the United States;
(2) additional inspectors are required to improve the Food
and Drug Administration's ability to safeguard the food
supply of the United States;
(3) because of the increasing volume of international trade
in food products the Secretary should make it a priority to
enter into agreements with the trading partners of the United
States with respect to food safety; and
(4) Congress should work to develop a comprehensive
response to the issue of food safety.
SEC. 1009. ANNUAL REPORT TO CONGRESS.
The Secretary shall, on an annual basis, submit to the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the Committee
on Energy and Commerce and the Committee on Appropriations of
the House of Representatives a report that includes, with
respect to the preceding 1-year period--
(1) the number and amount of food products regulated by the
Food and Drug Administration imported into the United States,
aggregated by country and type of food;
(2) a listing of the number of Food and Drug Administration
inspectors of imported food products referenced in paragraph
(1) and the number of Food and Drug Administration
inspections performed on such products; and
(3) aggregated data on the findings of such inspections,
including data related to violations of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 201 et seq.), and
enforcement actions used to follow-up on such findings and
violations.
SEC. 1010. PUBLICATION OF ANNUAL REPORTS.
(a) In General.--The Commissioner of Food and Drugs shall
annually submit to Congress and publish on the Internet Web
site of the Food and Drug Administration, a report concerning
the results of the Administration's pesticide residue
monitoring program, that includes--
(1) information and analysis similar to that contained in
the report entitled ``Food and Drug Administration Pesticide
Program Residue Monitoring 2003'' as released in June of
2005;
(2) based on an analysis of previous samples, an
identification of products or countries (for imports) that
require special attention and additional study based on a
comparison with equivalent products manufactured,
distributed, or sold in the United States (including details
on the plans for such additional studies), including in the
initial report (and subsequent reports as determined
necessary) the results and analysis of the Ginseng Dietary
Supplements Special Survey as described on page 13 of the
report entitled ``Food and Drug Administration Pesticide
Program Residue Monitoring 2003'';
(3) information on the relative number of interstate and
imported shipments of each tested commodity that were
sampled, including recommendations on whether sampling is
statistically significant, provides confidence intervals or
other related statistical information, and whether the number
of samples should be increased and the details of any plans
to provide for such increase; and
(4) a description of whether certain commodities are being
improperly imported as another commodity, including a
description of additional steps that are being planned to
prevent such smuggling.
(b) Initial Reports.--Annual reports under subsection (a)
for fiscal years 2004 through 2006 may be combined into a
single report, by not later than June 1, 2008, for purposes
of publication under subsection (a). Thereafter such reports
shall be completed by June 1 of each year for the data
collected for the year that was 2-years prior to the year in
which the report is published.
(c) Memorandum of Understanding.--The Commissioner of Food
and Drugs, the Administrator of the Food Safety and
Inspection Service, the Department of Commerce, and the head
of the Agricultural Marketing Service shall enter into a
memorandum of understanding to permit inclusion of data in
the reports under subsection (a) relating to testing carried
out by the Food Safety and Inspection Service and the
Agricultural Marketing Service on meat, poultry, eggs, and
certain raw agricultural products, respectively.
SEC. 1011. RULE OF CONSTRUCTION.
Nothing in this title (or an amendment made by this title)
shall be construed to affect--
(1) the regulation of dietary supplements under the Dietary
Supplement Health and Education Act of 1994 (Public Law 103-
417); or
(2) the adverse event reporting system for dietary
supplements created under the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (Public Law 109-
462).
TITLE XI--OTHER PROVISIONS
Subtitle A--In General
SEC. 1101. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC
ARTICLES PUBLISHED BY FDA EMPLOYEES.
Subchapter A of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371 et seq.), as amended by section
701, is further amended by adding at the end the following:
``SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC
ARTICLES PUBLISHED BY FDA EMPLOYEES.
``(a) Definition.--In this section, the term `article'
means a paper, poster, abstract, book, book chapter, or other
published writing.
``(b) Policies.--The Secretary, through the Commissioner of
Food and Drugs, shall establish and make publicly available
clear written policies to implement this section and govern
the timely submission, review, clearance, and disclaimer
requirements for articles.
``(c) Timing of Submission for Review.--If an officer or
employee, including a Staff Fellow and a contractor who
performs staff work, of the Food and Drug Administration is
directed by the policies established under subsection (b) to
submit an article to the supervisor of such officer or
employee, or to some other official of the Food and Drug
Administration, for review and clearance before such officer
or employee may seek to publish or present such an article at
a conference, such officer or employee shall submit such
article for such review and clearance not less than 30 days
before submitting the article for publication or
presentation.
``(d) Timing for Review and Clearance.--The supervisor or
other reviewing official shall review such article and
provide written clearance, or written clearance on the
condition of specified changes being made, to such officer or
employee not later than 30 days after such officer or
employee submitted such article for review.
``(e) Non-Timely Review.--If, 31 days after such submission
under subsection (c), the supervisor or other reviewing
official has not cleared or has not reviewed such article and
provided written clearance, such officer or employee may
consider such article not to have been cleared and may submit
the article for publication or presentation with an
appropriate disclaimer as specified in the policies
established under subsection (b).
``(f) Effect.--Nothing in this section shall be construed
as affecting any restrictions on such publication or
presentation provided by other provisions of law.''.
SEC. 1102. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR
TROPICAL DISEASES.
Subchapter A of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at
the end the following:
``SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR
TROPICAL DISEASES.
``(a) Definitions.--In this section:
``(1) Priority review.--The term `priority review', with
respect to a human drug application as defined in section
735(1), means review and action by the Secretary on such
application not later than 6 months after receipt by the
Secretary of such application, as described in the Manual of
Policies and Procedures of the Food and Drug Administration
and goals identified in the letters described in section
101(c) of the Food and Drug Administration Amendments Act of
2007.
[[Page H10593]]
``(2) Priority review voucher.--The term `priority review
voucher' means a voucher issued by the Secretary to the
sponsor of a tropical disease product application that
entitles the holder of such voucher to priority review of a
single human drug application submitted under section
505(b)(1) or section 351 of the Public Health Service Act
after the date of approval of the tropical disease product
application.
``(3) Tropical disease.--The term `tropical disease' means
any of the following:
``(A) Tuberculosis.
``(B) Malaria.
``(C) Blinding trachoma.
``(D) Buruli Ulcer.
``(E) Cholera.
``(F) Dengue/dengue haemorrhagic fever.
``(G) Dracunculiasis (guinea-worm disease).
``(H) Fascioliasis.
``(I) Human African trypanosomiasis.
``(J) Leishmaniasis.
``(K) Leprosy.
``(L) Lymphatic filariasis.
``(M) Onchocerciasis.
``(N) Schistosomiasis.
``(O) Soil transmitted helmithiasis.
``(P) Yaws.
``(Q) Any other infectious disease for which there is no
significant market in developed nations and that
disproportionately affects poor and marginalized populations,
designated by regulation by the Secretary.
``(4) Tropical disease product application.--The term
`tropical disease product application' means an application
that--
``(A) is a human drug application as defined in section
735(1)--
``(i) for prevention or treatment of a tropical disease;
and
``(ii) the Secretary deems eligible for priority review;
``(B) is approved after the date of the enactment of the
Food and Drug Administration Amendments Act of 2007, by the
Secretary for use in the prevention, detection, or treatment
of a tropical disease; and
``(C) is for a human drug, no active ingredient (including
any ester or salt of the active ingredient) of which has been
approved in any other application under section 505(b)(1) or
section 351 of the Public Health Service Act.
``(b) Priority Review Voucher.--
``(1) In general.--The Secretary shall award a priority
review voucher to the sponsor of a tropical disease product
application upon approval by the Secretary of such tropical
disease product application.
``(2) Transferability.--The sponsor of a tropical disease
product that receives a priority review voucher under this
section may transfer (including by sale) the entitlement to
such voucher to a sponsor of a human drug for which an
application under section 505(b)(1) or section 351 of the
Public Health Service Act will be submitted after the date of
the approval of the tropical disease product application.
``(3) Limitation.--
``(A) No award for prior approved application.--A sponsor
of a tropical disease product may not receive a priority
review voucher under this section if the tropical disease
product application was submitted to the Secretary prior to
the date of the enactment of this section.
``(B) One-year waiting period.--The Secretary shall issue a
priority review voucher to the sponsor of a tropical disease
product no earlier than the date that is 1 year after the
date of the enactment of the Food and Drug Administration
Amendments Act of 2007.
``(4) Notification.--The sponsor of a human drug
application shall notify the Secretary not later than 365
days prior to submission of the human drug application that
is the subject of a priority review voucher of an intent to
submit the human drug application, including the date on
which the sponsor intends to submit the application. Such
notification shall be a legally binding commitment to pay for
the user fee to be assessed in accordance with this section.
``(c) Priority Review User Fee.--
``(1) In general.--The Secretary shall establish a user fee
program under which a sponsor of a human drug application
that is the subject of a priority review voucher shall pay to
the Secretary a fee determined under paragraph (2). Such fee
shall be in addition to any fee required to be submitted by
the sponsor under chapter VII.
``(2) Fee amount.--The amount of the priority review user
fee shall be determined each fiscal year by the Secretary and
based on the average cost incurred by the agency in the
review of a human drug application subject to priority review
in the previous fiscal year.
``(3) Annual fee setting.--The Secretary shall establish,
before the beginning of each fiscal year beginning after
September 30, 2007, for that fiscal year, the amount of the
priority review user fee.
``(4) Payment.--
``(A) In general.--The priority review user fee required by
this subsection shall be due upon the submission of a human
drug application under section 505(b)(1) or section 351 of
the Public Health Services Act for which the priority review
voucher is used.
``(B) Complete application.--An application described under
subparagraph (A) for which the sponsor requests the use of a
priority review voucher shall be considered incomplete if the
fee required by this subsection and all other applicable user
fees are not paid in accordance with the Secretary's
procedures for paying such fees.
``(C) No waivers, exemptions, reductions, or refunds.--The
Secretary may not grant a waiver, exemption, reduction, or
refund of any fees due and payable under this section.
``(5) Offsetting collections.--Fees collected pursuant to
this subsection for any fiscal year--
``(A) shall be deposited and credited as offsetting
collections to the account providing appropriations to the
Food and Drug Administration; and
``(B) shall not be collected for any fiscal year except to
the extent provided in advance in appropriation Acts.''.
SEC. 1103. IMPROVING GENETIC TEST SAFETY AND QUALITY.
(a) Report.--If the Secretary's Advisory Committee on
Genetics, Health, and Society does not complete and submit
the Regulatory Oversight of Genetic/Genomic Testing Report &
Action Recommendations to the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
by July of 2008, the Secretary shall enter into a contract
with the Institute of Medicine to conduct a study to assess
the overall safety and quality of genetic tests and prepare a
report that includes recommendations to improve Federal
oversight and regulation of genetic tests. Such study shall
take into consideration relevant reports by the Secretary's
Advisory Committee on Genetics, Health, and Society and other
groups and shall be completed not later than 1 year after the
date on which the Secretary entered into such contract.
(b) Rule of Construction.--Nothing in this section shall be
construed as requiring Federal efforts with respect to
regulatory oversight of genetic tests to cease or be limited
or delayed pending completion of the report by the
Secretary's Advisory Committee on Genetics, Health, and
Society or the Institute of Medicine.
SEC. 1104. NIH TECHNICAL AMENDMENTS.
The Public Health Service Act (42 U.S.C. 201 et seq.) is
amended--
(1) in section 319C-2(j)(3)(B), by striking ``section 319C-
1(h)'' and inserting ``section 319C-1(i)'';
(2) in section 402(b)(4), by inserting ``minority and
other'' after ``reducing'';
(3) in section 403(a)(4)(C)(iv)(III), by inserting ``and
postdoctoral training funded through research grants'' before
the semicolon;
(4) by designating the second section 403C (relating to the
drug diethylstilbestrol) as section 403D; and
(5) in section 403C(a)--
(A) in the matter preceding paragraph (1)--
(i) by inserting ``graduate students supported by the
National Institutes of Health'' after ``with respect to'';
and
(ii) by deleting ``each degree-granting program'';
(B) in paragraph (1), by inserting ``such'' after
``percentage of''; and
(C) in paragraph (2), by inserting ``(not including any
leaves of absence)'' after ``average time''.
SEC. 1105. SEVERABILITY CLAUSE.
If any provision of this Act, an amendment made this Act,
or the application of such provision or amendment to any
person or circumstance is held to be unconstitutional, the
remainder of this Act, the amendments made by this Act, and
the application of the provisions of such to any person or
circumstances shall not be affected thereby.
Subtitle B--Antibiotic Access and Innovation
SEC. 1111. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE
CONCENTRATIONS OF ANTIMICROBIALS.
(a) Definition.--In this section, the term ``clinically
susceptible concentrations'' means specific values which
characterize bacteria as clinically susceptible,
intermediate, or resistant to the drug (or drugs) tested.
(b) Identification.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary''),
through the Commissioner of Food and Drugs, shall identify
(where such information is reasonably available) and
periodically update clinically susceptible concentrations.
(c) Public Availability.--The Secretary, through the
Commissioner of Food and Drugs, shall make such clinically
susceptible concentrations publicly available, such as by
posting on the Internet, not later than 30 days after the
date of identification and any update under this section.
(d) Effect.--Nothing in this section shall be construed to
restrict, in any manner, the prescribing of antibiotics by
physicians, or to limit the practice of medicine, including
for diseases such as Lyme and tick-borne diseases.
SEC. 1112. 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. 1113. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE
ENANTIOMERS.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), as amended by
[[Page H10594]]
section 920, is further amended by adding at the end the
following:
``(u) Certain Drugs Containing Single Enantiomers.--
``(1) In general.--For purposes of subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is
submitted under subsection (b) for a non-racemic drug
containing as an active ingredient (including any ester or
salt of the active ingredient) a single enantiomer that is
contained in a racemic drug approved in another application
under subsection (b), the applicant may, in the application
for such non-racemic drug, elect to have the single
enantiomer not be considered the same active ingredient as
that contained in the approved racemic drug, if--
``(A)(i) the single enantiomer has not been previously
approved except in the approved racemic drug; and
``(ii) the application submitted under subsection (b) for
such non-racemic drug--
``(I) includes full reports of new clinical investigations
(other than bioavailability studies)--
``(aa) necessary for the approval of the application under
subsections (c) and (d); and
``(bb) conducted or sponsored by the applicant; and
``(II) does not rely on any investigations that are part of
an application submitted under subsection (b) for approval of
the approved racemic drug; and
``(B) the application submitted under subsection (b) for
such non-racemic drug is not submitted for approval of a
condition of use--
``(i) in a therapeutic category in which the approved
racemic drug has been approved; or
``(ii) for which any other enantiomer of the racemic drug
has been approved.
``(2) Limitation.--
``(A) No approval in certain therapeutic categories.--Until
the date that is 10 years after the date of approval of a
non-racemic drug described in paragraph (1) and with respect
to which the applicant has made the election provided for by
such paragraph, the Secretary shall not approve such non-
racemic drug for any condition of use in the therapeutic
category in which the racemic drug has been approved.
``(B) Labeling.--If applicable, the labeling of a non-
racemic drug described in paragraph (1) and with respect to
which the applicant has made the election provided for by
such paragraph shall include a statement that the non-racemic
drug is not approved, and has not been shown to be safe and
effective, for any condition of use of the racemic drug.
``(3) Definition.--
``(A) In general.--For purposes of this subsection, the
term `therapeutic category' means a therapeutic category
identified in the list developed by the United States
Pharmacopeia pursuant to section 1860D-4(b)(3)(C)(ii) of the
Social Security Act and as in effect on the date of the
enactment of this subsection.
``(B) Publication by secretary.--The Secretary shall
publish the list described in subparagraph (A) and may amend
such list by regulation.
``(4) Availability.--The election referred to in paragraph
(1) may be made only in an application that is submitted to
the Secretary after the date of the enactment of this
subsection and before October 1, 2012.''.
SEC. 1114. REPORT.
Not later than January 1, 2012, the Comptroller General of
the United States 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 that examines whether and how this subtitle
has--
(1) encouraged the development of new antibiotics and other
drugs; and
(2) prevented or delayed timely generic drug entry into the
market.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Michigan (Mr. Dingell) and the gentleman from Texas (Mr. Barton) each
will control 20 minutes.
The Chair recognizes the gentleman from Michigan.
General Leave
Mr. DINGELL. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and to include extraneous matter on the bill under consideration.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Michigan?
There was no objection.
Mr. DINGELL. Mr. Speaker, I yield myself 3 minutes.
Mr. Speaker, I rise today to express strong support for H.R. 3580,
the Food and Drug Administration Amendments Act of 2007. This is
excellent legislation. It contains needed reforms to strengthen the
safety of our Nation's drug, device, and food supply.
I want to pay a word of compliment to my Republican colleagues and
say that we have come to a compromise which I believe is satisfactory
in the broad public interest and is an excellent piece of legislation.
And I want to commend my friend Mr. Barton and our Republican
colleagues for having worked with us well on this matter.
On July 11, 2007, the House passed H.R. 2900, the Food and Drug
Administration Amendments, by a bipartisan vote of 403-16. The bill was
hailed by all as a strong bill that would improve the lives of
Americans by ensuring that drugs and devices are reviewed in a
competent and in a timely fashion.
Earlier this year the Senate passed a similar bill. Since July,
bipartisan meetings have been held frequently between the House Energy
and Commerce Committee and the Senate Committee on Health, Education,
Labor, and Pensions to reconcile the differences between the two bills.
This bill includes two very different user-fee programs, both vital
to the timely approval of lifesaving drugs and devices. The legislation
would significantly improve our postmarket safety programs, thereby
preventing many of the drug and device injuries and deaths that occur
today. It fills an important gap in therapies available to one of our
most vulnerable and important patient groups: our children. Finally, I
note that the period of market exclusivity in the pediatric studies
remains 6 months, as in current law.
I want to thank all the members of the committee who have worked hard
on this bill. They have endured long hours to ensure that this bill
would be completed before the expiration of the two user-fee programs
at the end of this month. And I want to pay particular tribute to the
staff on both sides for their outstanding labors.
Mr. Speaker, I want to point out that if this bill does not pass in
the time limits which are imposed upon us by the September 30
expiration of this statute, we will have significant problems here that
we may not be able to address because, I would point out, that failure
to do so will leave us with a situation where we are going to find that
RIF notices will be going out at Food and Drug and the ability to
approve new drugs will all of a sudden come to a screeching and
unfortunate halt.
{time} 1500
I urge my friends and colleagues to support this legislation; it is a
good piece of legislation, it has the support of all who have worked
with it, and I would commend it to the attention and the kindness of my
colleagues.
Mr. Speaker, I reserve the balance of my time.
Mr. BARTON of Texas. Mr. Speaker, I yield myself such time as I may
consume.
(Mr. BARTON of Texas asked and was given permission to revise and
extend his remarks.)
Mr. BARTON of Texas. Mr. Speaker, most of us are too young to
remember, but in the early days of the movies there was a series of
movies based on the ``Perils of Pauline.'' Pauline was a heroine who
always got tied to the railroad track, and just as the train was
bearing down on her the hero would come out and rescue her for another
adventure in the next movie reel.
Well, this bill before us has kind of experienced the Perils of
Pauline. It started out in a tremendous positive bipartisan spirit here
in the House. Chairman Dingell and Subcommittee Chairman Pallone on the
majority and Mr. Deal and myself on the minority side and our
colleagues in the rank-and-file worked together. We reported a bill,
and I don't remember how many votes it got on the House floor, but I
believe it was over 400. It got over to the other body, and they
modified it in some ways that were somewhat different than the House
bill. The negotiations broke down, and it looked for a while this week
that the Food and Drug Administration was going to have to send out
reduction in force notices to over 2,000 employees at the Food and Drug
Administration. But thanks to the tremendous leadership of Chairman
Dingell and Subcommittee Chairman Pallone and the help of people like
Congressman Waxman and others on the majority side, we've been able to
come back together and create a unified House position and work with
our friends in the other body. And they've accepted the compromise
that's before us to say that here, at 3 o'clock on Wednesday afternoon,
we're going to rescue Pauline and pass the PDUFA, I hope by unanimous
consent on the suspension calendar, the PDUFA reauthorization bill, and
lots of good things are going to happen.
I am honored to be the ranking member on the Energy and Commerce
Committee, along with Subcommittee
[[Page H10595]]
Ranking Member Deal, who has worked with the majority to put this
compromise together.
I want to stress the sensitivity of completing the reauthorization of
the Prescription Drug User Fee Program and the Medical Device User Fee
Program right now. As I said earlier, if we were not to have done that
by the end of this week, over 2,000 employees at the FDA would probably
have received a reduction in force notice sometime next week or the
week after. These are dedicated experts who are responsible for
reviewing and approving new drugs, biologics and medical devices. If we
were to lose those individuals, we would probably never get them back.
That would have severe negative repercussions for everybody in this
country.
The legislation before us will promote advancement in pediatric
therapies both for pharmaceuticals and for medical devices. The
Pediatric Rule and the Best Pharmaceuticals for Children Act have
helped to fill a void in pediatric medicine. Prior to these acts, many
children were not getting the best treatment because the information
was simply not available to determine how a drug would act on them.
Drugs do perform differently in different patients, which is especially
true when that patient is a child. These acts have begun to provide
physicians the information they need to make the best decisions for
their pediatric patients. These two acts work together to ensure that
accurate, timely pediatric use information is developed to ensure the
best medical outcomes for the Nation's children.
The bill preserves the 6-month incentive that companies receive to do
additional testing in pediatric populations. I want to emphasize that.
The bill before us preserves the 6-month pediatric exclusivity
provision in current law, and I think that's a real accomplishment.
Chairman Dingell should be commended for his leadership on that effort.
I was glad to support him in that insistence on that particular
provision. I would also like to thank Congresswoman Anna Eshoo for her
work on that provision.
Finally, the legislation addresses the issue of drug safety. No drug
is completely safe. All drugs have some risk. The goal of the Food and
Drug Administration is to ensure that the benefits of the drug outweigh
any potential risks and ensure that patients have access to life-saving
and life-improving medications.
The legislation before us today strives to ensure that the FDA has
the authority to monitor drugs to ensure that the balance between the
benefit and the risk remains in equilibrium. The FDA will now have the
authority to require that drug sponsors conduct postmarket clinical
trials. The FDA will now have the authority to require that a drug make
a label change. The FDA will also now have the authority to impose
additional requirements on a drug in the form of a risk evaluation and
mitigation strategy when it is needed to ensure that a drug's benefits
outweigh its risk.
Mr. Speaker, this bill is a bipartisan compromise that does
strengthen the FDA, it will improve children's health, and it will
reauthorize programs that are essential to ensuring that patients have
timely access to drugs and medical devices.
Before I reserve the balance of my time, I again want to thank
Chairman Dingell, Subcommittee Chairman Pallone, Ranking Member Deal,
and all the rank-and-file members. I also want to especially thank Ryan
Long on the minority staff, the gentleman that is sitting to my left.
He stayed up all last night working on these final nuances. I shouldn't
say this, but I'm told that he has the same clothes on today that he
had on yesterday because he has worked so hard on this bill. We do want
to give him special commendation. And I would urge that he take the
appropriate hygienic provisions as soon as possible.
With that, Mr. Speaker, I reserve the balance of my time.
Mr. DINGELL. Mr. Speaker, I ask unanimous consent that I be permitted
to yield the remainder of my time to the distinguished gentleman from
New Jersey (Mr. Pallone), the chairman of the subcommittee, and that he
be permitted to control the time.
The SPEAKER pro tempore. Without objection, the gentleman from New
Jersey is recognized.
There was no objection.
Mr. PALLONE. Thank you, Mr. Speaker, and I yield myself such time as
I may consume.
Mr. Speaker, this is an important day for American consumers. Thanks
to the legislation the House is about to pass, the Food and Drug
Administration will have the financial resources and authorities
necessary to ensure patients have timely access to safe and effective
therapies.
First and foremost, this bill is about drug safety. In order to
empower the FDA to protect the public from harmful drugs, we are giving
the agency new authority to compel important labeling changes. This is
a significant improvement over current policy, where FDA must haggle
with drug companies and protracted negotiations that put patients and
consumers at risk.
Under this bill, FDA will also be better equipped to force drug
manufacturers to fulfill their responsibility to the American public
and complete postmarket study commitments which are critical to
ensuring a drug is safe.
In addition to these important new authorities, this bill authorizes
the collection of $225 million in new user fees, a significant increase
in the amount of funds dedicated for the use of drug safety activities.
The FDA Revitalization Act also provides for commonsense improvements
to our Nation's food safety system, such as more stringent ingredient
and labeling standards, establishment of an adulterated food registry,
and improvements in public notifications.
Patients will be happy to know that the bill before us also requires
greater transparency of drug makers by calling for clinical trials to
be registered in a database monitored by the National Institutes of
Health, along with basic results data. As we saw with the case of
Avandia, making this information available to patients, providers and
researchers is critical to uncovering potential harmful effects of a
drug. And under this legislation, the public will also have greater
access to internal documents that FDA used in its review of a drug
application.
We also secure FDA scientists' right to publish by requiring the
Secretary to establish clear policies on the timely clearance of
articles written by FDA employees.
And finally, Mr. Speaker, this bill would make significant progress
in reducing the number of conflicted experts who serve on advisory
committees.
Mr. Speaker, I'm proud to say that this bill reauthorizes two very
important programs for our Nation's children, the Best Pharmaceuticals
for Children Act and the Pediatric Research and Equity Act. These
programs have been crucial in the successful cultivation of important
research used by doctors and parents to better determine what kinds of
drug therapy is safest and most appropriate for a child patient.
In addition to the two existing programs, we're creating a new
program that would help provide device manufacturers with greater
incentives to conduct research and development of pediatric devices.
Combined, these three bills will strengthen the research being done on
pediatric uses of drugs and devices, and will make sure that our
Nation's children have access to the medicines and therapies they need
to grow up healthy and strong.
And finally, this bill reauthorizes two critically important user fee
agreements with respect to prescription drugs and medical devices.
These programs provide FDA with the necessary resources to review
applications in a timely manner so patients who rely on new and
improved drugs and devices don't have to go without. In addition to
reauthorizing these existing user fee programs, this bill would
establish a new user fee for the specific purpose of reviewing direct-
to-consumer advertising.
I just want to commend Mr. Dingell, our ranking member Mr. Barton,
Mr. Deal, and all of the members here, Mr. Waxman, Ms. Eshoo, Mr.
Markey. Their leadership on these issues has been unwavering. It is to
their credit that we have a bill on the floor today.
This is a great victory for American consumers that will make
tremendous strides in empowering the FDA and restoring public
confidence in its ability to protect the public health, and I would
urge my colleagues to vigorously support it.
[[Page H10596]]
Mr. Speaker, I reserve the balance of my time.
Mr. BARTON of Texas. Mr. Speaker, I would ask unanimous consent that
the balance of the time on the minority side be yielded to Mr. Nathan
Deal, the ranking member of the Health Subcommittee, for him to use and
control as he sees fit.
The SPEAKER pro tempore. Without objection, the gentleman from
Georgia is recognized.
There was no objection.
Mr. DEAL of Georgia. Thank you, Mr. Speaker.
I want to, first of all, thank Chairman Dingell and Chairman Pallone
for working in a bipartisan fashion on this very important piece of
legislation.
As we all know, the work of the FDA is vital to the health and safety
of the citizens of this country, and especially legislation such as
this that enhances their ability to deal with the questions of drug
safety and the monitoring capabilities and the continuing programs that
are so vital both to the drugs and to medical devices which require
review and approval by the FDA.
The user fee programs that are being reauthorized by this legislation
are very important to fulfilling their role in meeting their personnel
needs to achieve a timely review of drugs and medical devices, and I
believe that Congress should not and cannot afford to delay further
action on this package. Certainly to do so would require FDA to begin
to scale back their personnel, and none of us want to see that happen.
Moreover, patients demand and deserve to know that the medications
they are taking are safe and effective, and that the FDA has adequate
resources, both pre- and postmarket, in order to ensure that the safety
of the Nation's drug supply is intact.
This legislation makes sensible bipartisan strides in that direction
and balances the need to bring new life-saving medications to market,
and at the same time provide the necessary protections for patient
safety.
Like all compromises, there was a necessary give-and-take from all
sides to bring this bill to the floor today. I think it is through the
responsible work of the leadership of our committee of Energy and
Commerce and through the processes that the committee has followed that
we were able to accomplish that on this very significant piece of
legislation.
I would urge my colleagues to vote in favor of the bill and hope that
our colleagues across the rotunda would do likewise so that we can
present a bill to the desk of the President for his signature which
will keep this vital program and functions of FDA going forward and
will not allow it to expire.
Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from
California who has been a leader on this issue for so many years.
Mr. WAXMAN. Mr. Speaker, the legislation we are considering provides
FDA with critical tools the agency has been desperately lacking in its
efforts to protect the American public from unsafe drugs. This
legislation will provide FDA with the ability to require companies to
update their drug label with new information, and FDA won't have to
haggle with companies to get them to make those changes.
It also says, in giving FDA this labeling change authority, Congress
is making it clear that we do not intend to impact a drug company's
responsibility to promptly update its label with safety information on
its own accord.
The legislation also gives FDA the authority to require companies to
conduct postmarket studies and clinical trials of drugs. And it creates
a mandatory clinical trial registry and results database to increase
the transparency of those trials.
{time} 1515
Mr. Speaker, before we break our arms trying to pat ourselves on the
back, I want to express my deep disappointment that today we are
walking away from a critical opportunity to make some reasonable
adjustments to the windfall profits that drug companies receive for
conducting pediatric studies under the Best Pharmaceuticals for
Children Act. This is not about whether those pediatric studies should
be done. We all agree about that. They are being done now. There is no
question they will continue to be done. But if we were to cut back
slightly on the term of exclusivity for only the blockbuster drugs,
that would make a great deal of difference to people who are paying the
high cost for pharmaceuticals.
In my view, we lost that opportunity, and it is going to hurt a lot
of our consumers. In my view, there is simply no justification for
rewarding companies with incentives that are so far in excess of the
actual cost of doing the studies themselves.
I am also deeply disturbed the legislation fails to remove the sunset
on FDA's authority to require pediatric studies under the Pediatric
Research and Equity Act. There is absolutely no reason Congress needs
to keep revisiting this commonsense measure that allows FDA to get
essential information about whether new therapies are safe and
effective for children.
So although I am pleased that today will provide FDA with important
new authorities and resources, I must express my deep regret that we
fail to take this opportunity to help individuals, businesses, State
governments and insurers who pay the bill for the higher prices that
result when generic competition is delayed for these expensive
blockbuster drugs. I think it is a shame. We are talking about drugs of
$5 billion in sales a year. If they spend a couple million dollars for
their studies, they are being overreimbursed at the consumer's expense.
Mr. DEAL of Georgia. Mr. Speaker, I have no other requested time and
would be prepared to close whenever the gentleman from New Jersey is
prepared.
Mr. PALLONE. Mr. Speaker, I yield 2\1/2\ minutes to the gentleman
from Massachusetts who, again, had quite a bit to do with this
legislation, particularly on the safety provisions.
Mr. MARKEY. First of all, I want to commend you, Mr. Chairman, and
Chairman Dingell, your staffs, Mr. Waxman, Ranking Member Barton and
Mr. Deal, all the Members on the Republican side for the product that
is here, all of the staff which has worked on it for so long. My own
staff, Kate Bazinsky, who is sitting right here, just was married 2
months ago, this has definitely affected those first 2 months of
marriage, the incredible negotiations that have taken place to reach
this point, along with Mark Bayer who was working on the privacy parts
of this legislation with your staffs. I congratulate everyone.
I am pleased that the final bill before us today retains the core
drug safety and clinical trial provisions from the bill that
Congressman Waxman and I introduced in March, which will improve
transparency at the FDA and make drugs safer. Although I had hoped the
sunset would be removed from the pediatric rule and less exclusivity
given to blockbuster products under the pediatric incentive program,
this bill is a historic achievement which will make drugs and medical
devices safer for consumers around the world.
The past several years have been marked by drug scandal after drug
scandal, Vioxx, Ketek, Paxil and Avandia. These drugs have harmed
families across the country and come to symbolize the urgent need for
reform at the FDA. Taking drugs should not be a game of RX roulette,
and yet the FDA's current system is broken, and thousands of American
families have been harmed by drugs with dangerous side effects.
Today, the House is responding to those failures. The bill is a
victory for consumers and for patients. The bill will empower the FDA
with important new authorities to mandate label changes and require
postmarket studies. However, these new FDA authorities do not change
the responsibility of companies to maintain drug labels and warn the
public about risk.
For the first time ever, the FDA will have the power to impose civil
monetary penalties on companies that fail to conduct required
postmarket studies. It will also establish a new postmarket risk
identification and analysis system to identify harmful side effects
without compromising patient privacy.
Since 2004, I have been fighting for a mandatory clinical trial
registry and results database which will ensure that the public has
accurate and complete information about drugs and devices.
[[Page H10597]]
This bill will create that mandatory clinical trials database.
I am also extremely pleased that the FDA package includes language
from the Markey-Rogers pediatric devices bill which is a major step
forward for getting better and better devices for kids.
Mr. Speaker, again, I thank the chairman from New Jersey for all his
great work.
Mr. PALLONE. Mr. Speaker, I would yield 3 minutes to the gentlewoman
from California (Ms. Eshoo) and point out, again, her leadership on
this issue, particularly with regard to children and the pediatric
issues.
Ms. ESHOO. Mr. Speaker, I thank the distinguished chairman of the
Health Subcommittee as well as all of my colleagues that have worked so
hard to bring this bill forward. So I rise, obviously, in support of it
because I think the bill is going to make an enormous difference in the
safety and the effectiveness of drugs and medical devices used to treat
adults and children.
I think the bill also strengthens the FDA. I think the American
people want the FDA to be an agency that is strong in its protection of
consumers around the country. We know that there have been shortcomings
that have had terrible effects on many families in our country. So, I
think this bill is a victory in that arena.
I am also pleased that the bill adopts much of my legislation
relative to children and pharmaceutical drugs for children. The
American Academy of Pediatrics has instructed us that only about 25
percent of drugs administered to children have been appropriately
tested and labeled for use in kids. Pediatricians often had to
prescribe adult pharmaceuticals for children by telling parents, ``cut
the pill in half, cut it in thirds, cut it in quarters.'' We understood
that we had to do better. By every measurement, the reauthorization of
this legislation, previous legislation, was supported because it was
very, very successful. We know that children are not small adults, and
the legislation recognizes that. We have reauthorized, and we are doing
the right thing.
I am pleased that the blockbuster provision is not a part of this
legislation. The other body supported that. I didn't. This bill
doesn't. In all negotiations, there is always give-and-take. There are
items I supported that didn't make it into the package, including the
permanent extension of the Pediatric Research Equity Act, which I
championed, obviously, as part of my legislation in the original House
bill. I hope that we can get to this at some point. I am sorry it is
not in this bill.
Overall, I want to thank all of my colleagues that made this possible
and that we are here today; certainly, Chairman Dingell, Ranking Member
Barton, most especially the professional staff, because they do so much
work, no one more than John Ford of our staff, and Virgil Miller. I
would like to also thank Jennifer Nieto Carey, formerly of my staff,
who worked so hard and extensively to help bring us to this point.
So this is a good bill. I think the whole House should support it. I
think it is a tribute to the substance of it, that it is coming up
under suspension. I salute everyone that made the effort a winning one.
Most importantly, I think the bill is a winner for the people of our
country, both children and adults.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from
Oregon (Ms. Hooley).
Ms. HOOLEY. Mr. Speaker, I would like to thank my colleague from New
Jersey who has done a fabulous job of chairing the subcommittee.
Mr. Speaker, I rise today in strong support of H.R. 3580. Patients
and consumers are the clear winners in this legislation today. This
legislation will save lives by promoting the safe and quick approval of
lifesaving medications and providing the FDA with vital new authority
to protect consumers after a drug is on the market. This bill collects
an additional $225 million over 5 years to enhance drug safety reviews
and also promotes testing of pharmaceuticals and medical devices to
ensure that they are safe for children.
Revisions I crafted with my colleague, Mr. Doyle, the FDA and others
require the creation of a unique device identification, or a UDI,
system for medical devices that will help take important strides to
improve the public health. Medical devices cannot easily be tracked or
identified in any systemic fashion with current tools. A UDI system
will enable the FDA to detect warning signs of a defective device
earlier and quickly respond to recalls. Every person with an artificial
knee, hip, pacemaker or any one of the thousands of other medical
devices will benefit once this UDI system is in place.
Mr. Speaker, I urge my colleagues to support this bipartisan and
comprehensive drug and device safety bill.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from
Illinois (Ms. Schakowsky).
Ms. SCHAKOWSKY. Mr. Speaker, I want to thank Chairman Dingell and
Chairman Pallone, Mr. Waxman and Mr. Markey and Congresswoman Eshoo and
all my colleagues on both sides of the aisle and their hardworking
staffs for bringing this landmark bill to the floor today.
This bill strikes to the heart of some of FDA's most troubling issues
by granting additional authorities to the Food and Drug Administration
that are critical to enhancing drug safety. This bill gives consumers a
larger role in deciding how user fees are spent to enhance drug safety,
a huge victory for consumer protection. It will take steps to enhance
the kind of information that will be available to patients and their
families as they make personal decisions regarding their health care.
I am particularly pleased by the inclusion of an amendment I offered
that will improve consumer's awareness of the MedWatch program, one of
FDA's best but least known ways of monitoring adverse drug events once
a product has been approved. Consumer reports of bad effects signal to
FDA when prescription drugs pose a threat. The success of this program
is crucial to postmarketing surveillance. Unfortunately, 9 out of 10
Americans are unaware that the MedWatch program exists, yet adverse
drug and device reactions account for as many as 100,000 deaths every
year.
My amendment requires that printed prescription drug ads include
information on how to report side effects to the FDA's MedWatch
program, both on the Internet and through a 1-800 number. It also
requires the FDA to do a study on how we can best include this
important information on the TV ads that have become so pervasive and
influential in our society. So, again, I thank the chairman and staff
for working with me to include this language.
This bill makes a strong statement about the importance of protecting
people who rely on prescription medications to get through their day
and remain active members of society. I am encouraged by the steps it
takes toward a safer, more transparent Food and Drug Administration.
Mr. Speaker, I urge all my colleagues to support it.
Mr. DEAL of Georgia. Mr. Speaker, I have no other requests for time.
Mr. Speaker, I thank our staff and urge the adoption of this bill and
I yield back the balance of our time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I just want to thank everyone, particularly the staff
that were involved in putting this legislation together and all the
negotiations. I want to thank our legislative counsel, Warren Burke,
Energy and Commerce Republicans, Ryan Long and Nandan Kenkeremath; Mr.
Deal's staff, John Little; our Energy and Commerce Democrats, John
Ford, Pete Goodloe, Virgil Miller, Bobby Clark; and Mr. Waxman's staff,
Karen Nelson, Rachel Sher, Stephen Cha, Anne Witt; and also Mr.
Markey's staffperson, Kate Bazinsky.
Needless to say, this bill is a product of a lot of hard work here in
the House on both sides of the aisle, and, of course, we are also
expecting, since this is going to be a consensus bill passed on the
suspension list today, that it will pass easily in the Senate hopefully
tonight or tomorrow. And it really addresses the problems and the
safety issues that have come to light in the last few years.
{time} 1530
I think many of us know there has been a lot of media attention to
the fact that oftentimes drugs in the postmarketing situation have been
problems. People have died. People have gotten sick. This bill I think
effectively addresses those issues. I hope
[[Page H10598]]
and expect that it will be noticed, because it will make a difference
in people's lives.
Mr. WAXMAN. Mr. Speaker, the legislation are poised to pass today
provides FDA, for the first time, critical tools that the Agency has
been desperately lacking in its efforts to protect the American public
from unsafe drugs.
This legislation will provide FDA with the ability to require
companies to update their drug label with new safety information. Our
goal here is to address tragic situations like Vioxx. In that case,
because FDA could not compel the company to promptly make a labeling
change, the Agency haggled with the company for 14 months before
consumers were finally warned about serious cardiac risks in the drug
label. This is simply unacceptable.
However, this legislation will make clear that, in giving FDA this
labeling change authority, Congress does not intend to impact, in any
way, a drug company's responsibility to promptly update its label with
safety information on its own accord. Under FDA's current regulations,
companies are required to add new warnings to their labels as soon as
they learn of new dangers, even if FDA has not yet required the change.
In promulgating those regulations, FDA made a sensible policy choice.
FDA recognized that the companies themselves are in the best position
to know about risks associated with their own drugs. Logically, then,
the companies should also be charged with the duty to make consumers
aware of a drug's risk at the earliest possible moment. FDA recognized
that drug safety is first and foremost a shared responsibility between
the Agency and the company. And, today, Congress is making it clear
that we do not mean to disrupt that balance.
This legislation will also give FDA for the first time the authority
to require companies to conduct post-market studies and clinical trials
of drugs. Another section of the bill creates a mandatory clinical
trial registry and results database to increase the transparency of
those trials. Both of these provisions will make a critical
contribution towards increasing the safety of our drugs once they are
on the market.
But I want to express my deep disappointment that this legislation
failed to adopt a compromise that would have provided consumers with
much-needed relief from the ever-increasing cost of drugs. Today, we
are walking away from a critical and very rare opportunity to make some
reasonable adjustments to the windfall profits drug companies receive
for conducting pediatric studies under the Best Pharmaceuticals for
Children Act.
This is not about whether these pediatric studies should be done. We
all agree about that. They are being done now. And there is no question
that they would continue to be done if we were to cut back slightly on
the term of exclusivity for just the blockbuster drugs that are
realizing profits many times over the cost of doing pediatric studies.
The Senate did this in its bill and I regret that the compromise
agreement we are considering today did not reflect anything from the
Senate approach on this issue.
In my view, there simply is no justification for rewarding companies
with incentives that are far in excess of the actual costs of the
studies themselves--often hundreds of times over.
I also am deeply disturbed that this legislation fails to remove what
is an unprecedented sunset on FDA's statutory authority to require
pediatric studies under the Pediatric Research and Equity Act. There is
no reason Congress needs to keep revisiting this common sense measure
that allows FDA to get critical information about whether new therapies
are safe and effective for children--FDA quite obviously needs to have
the ability to require that new treatments be tested in children. And
there need not be any further discussion about that.
So, although I am pleased that we will provide FDA with critical new
authorities and resources in this bill today, I must express my deep
regret that we failed to take this opportunity to help individuals,
businesses, State governments, and insurers who pay the bill for the
higher prices that result when generic competition is delayed for these
expensive, blockbuster drugs.
Mr. GENE GREEN of Texas. Mr. Speaker, I rise in strong support of
this conference agreement 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 intense negotiations between the
House and Senate, whose negotiators have worked tirelessly to reach
consensus on this legislation. They did so with a looming deadline of
September 31, after which the user fee program would expire and many
hard-working FDA scientists would likely lose their jobs. To reach a
compromise, all parties to the negotiation had to give and take, but I
am pleased that the product before us represents something we can all
support. I would like to congratulate the negotiators on their success.
The FDA Amendments Act of 2007 makes important changes at the FDA to
place a greater emphasis on post-market surveillance within the agency.
The Risk, Evaluation, and Mitigation Strategy established by this bill
would give the agency the authority to monitor drugs 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 5
years for postmarket surveillance activities at the FDA. This
additional funding represents an important investment by the
pharmaceutical industry in the FDA's post-market safety activities,
while also ensuring that pre-market user fees are adequate to bring
potentially life-saving medicines to market in a reasonable time.
There is no question that the labeling and liability language
prompted a great deal of debate during conference negotiations, but one
thing is clear: the Congress in no way intends to limit the ability of
a patient injured by a drug to seek redress from our Nation's justice
system. FDA should have the ability to require labeling changes, but
that additional authority does not absolve the drug manufacturer of any
duty to initiate labeling changes on their own when new data bears out
the need for a change. The implementation of stronger drug safety
authorities does not mean that drug companies get a free pass when
their products harm consumers. I am pleased that the conference
agreement makes this point perfectly clear.
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, which help ensure that pharmaceuticals are tested
for their effect on children. After all, we know that children are not
simply smaller adults, and part of protecting America's children is
knowing how best to treat them when they face health concerns.
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. ESHOO. Mr. Speaker, I rise in support of H.R. 3580, the Food and
Drug Administration Amendments Act.
This bill will make an enormous difference in the safety and
effectiveness of drugs and medical devices used to treat adults and
children.
I'm pleased that the bill adopts much of my legislation (H.R. 2589,
Improving Pharmaceuticals for Children Act) to renew the Best
Pharmaceuticals for Children Act (BPCA) and the Pediatric Research
Equity Act (PREA). Together, BPCA and PREA represent two halves of a
comprehensive effort to make sure that prescription drugs are
appropriately tested and labeled for children.
According to the American Academy of Pediatrics, about 25 percent of
drugs administered to children have been appropriately tested and
labeled 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 are not
small adults; they 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.
The bill helps improve drug safety for children in two ways. First,
under BPCA, the bill provides an incentive, an extra 6 months of
marketing exclusivity, for a drug if the innovator company agrees to
undertake comprehensive pediatric studies requested by the FDA. Second,
under PREA, FDA is granted authority to require studies when there is a
demonstrated need and drug companies are required to submit a pediatric
assessment each time they apply to market a new drug or change an
existing drug's indication.
I'm pleased this bill continues the BPCA incentive without the so-
called ``blockbuster provision'' adopted by the Senate. The Senate's
proposal would have reduced the incentive for drugs with annual sales
of $1 billion, and, I believe the Senate language had the potential to
kill ``the goose that laid the golden egg.'' The 6-month incentive has
worked. According to GAO, 81 percent of the time FDA has offered this
incentive for a drug, drug companies have accepted, undertaking studies
that have generated pediatric data that would otherwise not have been
available. Scaling back the incentive for ``blockbusters'' would risk
that proven record of success. That is a gamble on the
[[Page H10599]]
health of children, and I'm pleased it's not in the bill.
In all negotiations there is give and take. There are items I
supported that didn't make it into this package, including the
permanent extension of PREA which I championed as part of my
legislation and the original House bill. I hope we'll have a chance to
revisit the issue in the next reauthorization, if not sooner.
On balance, this bill will make a huge improvement in the safety of
drugs and devices. We should pass it and send it to the President
today.
I want to commend Chairman Dingell, Ranking Member Barton and the
professional staff of the House Energy and Commerce Committee,
especially John Ford and Virgil Miller, as well as Jennifer Nieto Carey
formerly of my staff, who worked extensively on this bill.
Mr. PALLONE. Mr. Speaker, I want to thank everyone again, and I yield
back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Michigan (Mr. Dingell) that the House suspend the rules
and pass the bill, H.R. 3580.
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 vote was taken by electronic device, and there were--yeas 405,
nays 7, not voting 20, as follows:
[Roll No. 885]
YEAS--405
Abercrombie
Ackerman
Aderholt
Akin
Alexander
Altmire
Arcuri
Baca
Bachmann
Bachus
Baird
Baker
Baldwin
Barrett (SC)
Barrow
Bartlett (MD)
Barton (TX)
Bean
Becerra
Berkley
Berman
Berry
Biggert
Bilbray
Bilirakis
Bishop (GA)
Bishop (NY)
Blackburn
Blumenauer
Bonner
Bono
Boozman
Boren
Boswell
Boucher
Boustany
Boyd (FL)
Boyda (KS)
Brady (PA)
Brady (TX)
Braley (IA)
Broun (GA)
Brown (SC)
Brown, Corrine
Brown-Waite, Ginny
Buchanan
Burgess
Burton (IN)
Butterfield
Buyer
Calvert
Camp (MI)
Campbell (CA)
Cannon
Capito
Capps
Capuano
Cardoza
Carnahan
Carson
Castle
Castor
Chabot
Chandler
Clarke
Clay
Cleaver
Clyburn
Coble
Cohen
Conaway
Conyers
Cooper
Costa
Costello
Courtney
Cramer
Crenshaw
Crowley
Cuellar
Culberson
Cummings
Davis (AL)
Davis (CA)
Davis (IL)
Davis (KY)
Davis, David
Davis, Lincoln
Davis, Tom
Deal (GA)
DeFazio
DeGette
Delahunt
DeLauro
Dent
Diaz-Balart, L.
Diaz-Balart, M.
Dingell
Doggett
Donnelly
Doolittle
Doyle
Drake
Dreier
Edwards
Ehlers
Ellison
Ellsworth
Emanuel
Engel
English (PA)
Eshoo
Etheridge
Everett
Fallin
Farr
Fattah
Feeney
Ferguson
Filner
Forbes
Fortenberry
Fossella
Foxx
Frank (MA)
Franks (AZ)
Frelinghuysen
Gallegly
Garrett (NJ)
Gerlach
Giffords
Gilchrest
Gillibrand
Gingrey
Gohmert
Gonzalez
Goodlatte
Gordon
Graves
Green, Al
Green, Gene
Grijalva
Gutierrez
Hall (NY)
Hall (TX)
Hare
Harman
Hastert
Hastings (FL)
Hastings (WA)
Hayes
Heller
Hensarling
Herger
Herseth Sandlin
Higgins
Hill
Hinojosa
Hirono
Hobson
Hodes
Hoekstra
Holden
Holt
Honda
Hooley
Hoyer
Hulshof
Hunter
Inglis (SC)
Inslee
Israel
Issa
Jackson (IL)
Jackson-Lee (TX)
Jefferson
Johnson (IL)
Johnson, E. B.
Johnson, Sam
Jones (NC)
Jones (OH)
Jordan
Kagen
Kanjorski
Kaptur
Keller
Kennedy
Kildee
Kilpatrick
Kind
King (IA)
King (NY)
Kingston
Kirk
Klein (FL)
Kline (MN)
Knollenberg
Kuhl (NY)
LaHood
Lamborn
Lampson
Langevin
Lantos
Larsen (WA)
Larson (CT)
Latham
LaTourette
Lee
Levin
Lewis (CA)
Lewis (GA)
Lewis (KY)
Linder
Lipinski
LoBiondo
Loebsack
Lofgren, Zoe
Lowey
Lucas
Lungren, Daniel E.
Lynch
Mack
Mahoney (FL)
Maloney (NY)
Manzullo
Marchant
Markey
Marshall
Matheson
Matsui
McCarthy (CA)
McCarthy (NY)
McCaul (TX)
McCollum (MN)
McCrery
McDermott
McGovern
McHenry
McIntyre
McKeon
McMorris Rodgers
McNerney
McNulty
Meek (FL)
Meeks (NY)
Melancon
Mica
Michaud
Miller (FL)
Miller (MI)
Miller (NC)
Miller, Gary
Miller, George
Mitchell
Mollohan
Moore (KS)
Moore (WI)
Moran (KS)
Moran (VA)
Murphy (CT)
Murphy, Patrick
Murphy, Tim
Murtha
Musgrave
Myrick
Nadler
Napolitano
Neal (MA)
Neugebauer
Nunes
Oberstar
Obey
Olver
Pallone
Pascrell
Pastor
Payne
Pearce
Pence
Perlmutter
Peterson (MN)
Peterson (PA)
Petri
Pickering
Pitts
Platts
Poe
Pomeroy
Porter
Price (GA)
Price (NC)
Pryce (OH)
Radanovich
Rahall
Ramstad
Rangel
Regula
Rehberg
Reichert
Renzi
Reyes
Reynolds
Richardson
Rodriguez
Rogers (AL)
Rogers (KY)
Rogers (MI)
Rohrabacher
Ros-Lehtinen
Roskam
Ross
Rothman
Roybal-Allard
Royce
Ruppersberger
Rush
Ryan (OH)
Ryan (WI)
Salazar
Sali
Sanchez, Linda T.
Sanchez, Loretta
Sarbanes
Saxton
Schakowsky
Schiff
Schmidt
Schwartz
Scott (GA)
Scott (VA)
Sensenbrenner
Serrano
Sessions
Sestak
Shadegg
Shays
Shea-Porter
Sherman
Shimkus
Shuler
Shuster
Simpson
Sires
Skelton
Slaughter
Smith (NE)
Smith (NJ)
Smith (TX)
Smith (WA)
Snyder
Solis
Souder
Space
Spratt
Stark
Stearns
Stupak
Sullivan
Sutton
Tancredo
Tanner
Tauscher
Taylor
Terry
Thompson (CA)
Thompson (MS)
Thornberry
Tiahrt
Tiberi
Tierney
Towns
Turner
Udall (CO)
Udall (NM)
Upton
Van Hollen
Velazquez
Visclosky
Walberg
Walden (OR)
Walsh (NY)
Walz (MN)
Wamp
Wasserman Schultz
Watson
Watt
Waxman
Weiner
Welch (VT)
Weldon (FL)
Weller
Westmoreland
Wexler
Whitfield
Wicker
Wilson (NM)
Wilson (OH)
Wilson (SC)
Wolf
Woolsey
Wu
Wynn
Yarmuth
Young (AK)
Young (FL)
NAYS--7
Duncan
Emerson
Flake
Goode
Hinchey
Kucinich
Paul
NOT VOTING--20
Allen
Andrews
Bishop (UT)
Blunt
Boehner
Cantor
Carney
Carter
Cole (OK)
Cubin
Davis, Jo Ann
Dicks
Granger
Jindal
Johnson (GA)
McCotter
McHugh
Ortiz
Putnam
Waters
{time} 1555
Mr. GOODE changed his vote from ``yea'' to ``nay.''
Mr. PRICE of North Carolina changed his vote from ``nay'' to ``yea.''
So (two-thirds being in the affirmative) the rules were suspended and
the bill was passed.
The result of the vote was announced as above recorded.
A motion to reconsider was laid on the table
Stated for:
Mr. COLE of Oklahoma. Mr. Speaker, on Wednesday, September 19, 2007,
I was unavoidably detained due to a prior obligation.
Had I been present and voting, I would have voted ``yea'' on rollcall
No. 885.
____________________