[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3580 Enrolled Bill (ENR)]
H.R.3580
One Hundred Tenth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Thursday,
the fourth day of January, two thousand and seven
An Act
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.
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.
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 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 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 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 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;
``(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:
``(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
Fee Type Year 2008 Year 2009 Year 2010 Year 2011 Year 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:
``(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 subsections (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 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--
(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--
(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 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'';
(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 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, 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)--
``(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).
``(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
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).
``(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
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.
``(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-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.
``(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;
``(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.
``(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 clauses (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.
``(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
paragraphs (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 paragraphs (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
paragraphs (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. 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 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 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:
5``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
``(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 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--
``(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 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
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.
``(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
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
``(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 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 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 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
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.
``(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 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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.