[House Report 119-352]
[From the U.S. Government Publishing Office]
119th Congress } { Report
HOUSE OF REPRESENTATIVES
1st Session } { 119-352
======================================================================
GIVE KIDS A CHANCE ACT OF 2025
_______
October 31, 2025.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Guthrie, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 1262]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 1262) to amend the Federal Food, Drug, and
Cosmetic Act with respect to molecularly targeted pediatric
cancer investigations, and for other purposes, having
considered the same, reports favorably thereon with an
amendment and recommends that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 9
Background and Need for Legislation.............................. 9
Committee Action................................................. 11
Committee Votes.................................................. 11
Oversight Findings and Recommendations........................... 13
New Budget Authority, Entitlement Authority, and Tax Expenditures 13
Congressional Budget Office Estimate............................. 13
Federal Mandates Statement....................................... 13
Statement of General Performance Goals and Objectives............ 13
Duplication of Federal Programs.................................. 13
Related Committee and Subcommittee Hearings...................... 13
Committee Cost Estimate.......................................... 13
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 14
Advisory Committee Statement..................................... 14
Applicability to Legislative Branch.............................. 14
Section-by-Section Analysis of the Legislation................... 14
Changes in Existing Law Made by the Bill, as Reported............ 15
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Give Kids a Chance
Act of 2025''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Research into pediatric uses of drugs; additional authorities of
Food and Drug Administration regarding molecularly targeted
cancer drugs.
Sec. 3. Ensuring completion of pediatric study requirements.
Sec. 4. FDA report on PREA enforcement.
Sec. 5. Extension of authority to issue priority review vouchers to
encourage treatments for rare pediatric diseases.
Sec. 6. Limitations on exclusive approval or licensure of orphan drugs.
Sec. 7. Program for pediatric studies of drugs.
Sec. 8. Organ Procurement and Transplantation Network.
Sec. 9. Establishment of Abraham Accords Office within Food and Drug
Administration.
Sec. 10. Increasing transparency in generic drug applications.
Sec. 11. Medicare Improvement Fund.
SEC. 2. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL AUTHORITIES
OF FOOD AND DRUG ADMINISTRATION REGARDING
MOLECULARLY TARGETED CANCER DRUGS.
(a) In General.--
(1) Additional active ingredient for application drug;
limitation regarding novel-combination application drug.--
Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355c(a)(3)) is amended--
(A) by redesignating subparagraphs (B) and (C) as
subparagraphs (C) and (D), respectively; and
(B) by striking subparagraph (A) and inserting the
following:
``(A) In general.--For purposes of paragraph (1)(B),
the investigation described in this paragraph is a
molecularly targeted pediatric cancer investigation
of--
``(i) the drug or biological product for
which the application referred to in such
paragraph is submitted; or
``(ii) such drug or biological product used
in combination with--
``(I) an active ingredient of a drug
or biological product--
``(aa) for which an approved
application under section
505(j) under this Act or under
section 351(k) of the Public
Health Service Act is in
effect; and
``(bb) that is determined by
the Secretary, after
consultation with the
applicant, to be part of the
standard of care for treating a
pediatric cancer; or
``(II) an active ingredient of a drug
or biological product--
``(aa) for which an approved
application under section
505(b) of this Act or section
351(a) of the Public Health
Service Act to treat an adult
cancer is in effect and is held
by the same person submitting
the application under paragraph
(1)(B); and
``(bb) that is directed at a
molecular target that the
Secretary determines to be
substantially relevant to the
growth or progression of a
pediatric cancer.
``(B) Additional requirements.--
``(i) Design of investigation.--A molecularly
targeted pediatric cancer investigation
referred to in subparagraph (A) shall be
designed to yield clinically meaningful
pediatric study data that is gathered using
appropriate formulations for each age group for
which the study is required, regarding dosing,
safety, and preliminary efficacy to inform
potential pediatric labeling.
``(ii) Limitation.--An investigation
described in subparagraph (A)(ii) may be
required only if the drug or biological product
for which the application referred to in
paragraph (1)(B) contains either--
``(I) a single new active ingredient;
or
``(II) more than one active
ingredient, if an application for the
combination of active ingredients has
not previously been approved but each
active ingredient is in a drug product
that has been previously approved to
treat an adult cancer.
``(iii) Results of already-completed
preclinical studies of application drug.--With
respect to an investigation required pursuant
to paragraph (1)(B), the Secretary may require
the results of any completed preclinical
studies relevant to the initial pediatric study
plan be submitted to the Secretary at the same
time that the initial pediatric study plan
required under subsection (e)(1) is submitted.
``(iv) Rule of construction regarding
inactive ingredients.--With respect to a
combination of active ingredients referred to
in subparagraph (A)(ii), such subparagraph
shall not be construed as addressing the use of
inactive ingredients with such combination.''.
(2) Determination of applicable requirements.--Section
505B(e)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c(e)(1)) is amended by adding at the end the
following: ``The Secretary shall determine whether subparagraph
(A) or (B) of subsection (a)(1) applies with respect to an
application before the date on which the applicant is required
to submit the initial pediatric study plan under paragraph
(2)(A).''.
(3) Clarifying applicability.--Section 505B(a)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) is
amended by adding at the end the following:
``(C) Rule of construction.--No application that is
subject to the requirements of subparagraph (B) shall
be subject to the requirements of subparagraph (A), and
no application (or supplement to an application) that
is subject to the requirements of subparagraph (A)
shall be subject to the requirements of subparagraph
(B).''.
(4) Conforming amendments.--Section 505B(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended--
(A) in paragraph (3)(C), as redesignated by paragraph
(1)(A) of this subsection, by striking ``investigations
described in this paragraph'' and inserting
``investigations referred to in subparagraph (A)''; and
(B) in paragraph (3)(D), as redesignated by paragraph
(1)(A) of this subsection, by striking ``the
assessments under paragraph (2)(B)'' and inserting
``the assessments required under paragraph (1)(A)''.
(b) Guidance.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall--
(1) not later than 12 months after the date of enactment of
this Act, issue draft guidance on the implementation of the
amendments made by subsection (a); and
(2) not later than 12 months after closing the comment period
on such draft guidance, finalize such guidance.
(c) Applicability.--The amendments made by this section apply with
respect to any application under section 505(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(b)) and any application under
section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)),
that is submitted on or after the date that is 3 years after the date
of enactment of this Act.
(d) Reports to Congress.--
(1) Secretary of health and human services.--Not later than 6
years after the date of enactment of this Act, the Secretary of
Health and Human Services shall 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 Secretary's efforts, in coordination
with industry, to ensure implementation of the amendments made
by subsection (a).
(2) GAO study and report.--
(A) Study.--Not later than 8 years after the date of
enactment of this Act, the Comptroller General of the
United States shall conduct a study of the
effectiveness of requiring assessments and
investigations described in section 505B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as
amended by subsection (a), in the development of drugs
and biological products for pediatric cancer
indications, including consideration of any benefits
to, or burdens on, pediatric cancer drug development.
(B) Findings.--Not later than 10 years after the date
of enactment of this Act, the Comptroller General shall
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
containing the findings of the study conducted under
subparagraph (A).
SEC. 3. ENSURING COMPLETION OF PEDIATRIC STUDY REQUIREMENTS.
(a) Equal Accountability for Pediatric Study Requirements.--Section
505B(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d))
is amended--
(1) in paragraph (1), by striking ``Beginning 270'' and
inserting ``Noncompliance letter.--Beginning 270'';
(2) in paragraph (2)--
(A) by striking ``The drug or'' and inserting
``Effect of noncompliance.--The drug or''; and
(B) by striking ``(except that the drug or biological
product shall not be subject to action under section
303)'' and inserting ``(except that the drug or
biological product shall be subject to action under
section 303 only if such person demonstrated a lack of
due diligence in satisfying the applicable
requirement)''; and
(3) by adding at the end the following:
``(3) Limitation.--The Secretary shall not issue enforcement
actions under section 303 for failures under this subsection in
the case of a drug or biological product that is no longer
marketed.''.
(b) Due Diligence.--Section 505B(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c(d)), as amended by subsection (a), is
further amended by adding at the end the following:
``(4) Due diligence.--Before the Secretary may conclude that
a person failed to submit or otherwise meet a requirement as
described in the matter preceding paragraph (1), the Secretary
shall--
``(A) issue a noncompliance letter pursuant to
paragraph (1);
``(B) provide such person with a 45-day period
beginning on the date of receipt of such noncompliance
letter to respond in writing as set forth in such
paragraph; and
``(C) after reviewing such written response,
determine whether the person demonstrated a lack of due
diligence in satisfying such requirement.''.
(c) Conforming Amendments.--Section 303(f)(4)(A) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333(f)(4)(A)) is amended by striking
``or 505-1'' and inserting ``505-1, or 505B''.
(d) Transition Rule.--The Secretary of Health and Human Services may
take enforcement action under section 303 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 333) only for failures described in section
505B(d) of such Act (21 U.S.C. 355c(d)) that occur on or after the date
that is 180 days after the date of enactment of this Act.
SEC. 4. FDA REPORT ON PREA ENFORCEMENT.
Section 508(b) of the Food and Drug Administration Safety and
Innovation Act (21 U.S.C. 355c-1(b)) is amended--
(1) in paragraph (11), by striking the semicolon at the end
and inserting ``, including an evaluation of compliance with
deadlines provided for in deferrals and deferral extensions;'';
(2) in paragraph (15), by striking ``and'' at the end;
(3) in paragraph (16), by striking the period at the end and
inserting ``; and''; and
(4) by adding at the end the following:
``(17) a listing of penalties, settlements, or payments under
section 303 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353) for failure to comply with requirements under such
section 505B, including, for each penalty, settlement, or
payment, the name of the drug, the sponsor thereof, and the
amount of the penalty, settlement, or payment imposed.''.
SEC. 5. EXTENSION OF AUTHORITY TO ISSUE PRIORITY REVIEW VOUCHERS TO
ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES.
(a) Extension.--Paragraph (5) of section 529(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360ff(b)) is amended by striking
``December 20, 2024, unless'' and all that follows through the period
at the end and inserting ``September 30, 2029.''.
(b) User Fee Payment.--Section 529(c)(4) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360ff(c)(4)) is amended by striking
subparagraph (A) and inserting the following:
``(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(a) of the Public Health
Service Act for which the priority review voucher is
used. All other user fees associated with the human
drug application shall be due as required by the
Secretary or under applicable law.''.
(c) GAO Report on Effectiveness of Rare Pediatric Disease Priority
Voucher Awards in Incentivizing Rare Pediatric Disease Drug
Development.--
(1) GAO study.--
(A) Study.--The Comptroller General of the United
States shall conduct a study of the effectiveness of
awarding rare pediatric disease priority vouchers under
section 529 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360ff), as amended by subsection (a), in the
development of human drug products that treat or
prevent rare pediatric diseases (as defined in such
section 529).
(B) Contents of study.--In conducting the study under
subparagraph (A), the Comptroller General shall examine
the following:
(i) The indications for each drug or
biological product that--
(I) is the subject of a rare
pediatric disease product application
(as defined in section 529 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360ff)) for which a priority
review voucher was awarded; and
(II) was approved under section 505
of the Federal Food, Drug, and Cosmetic
Act (42 U.S.C. 355) or licensed under
section 351 of the Public Health
Service Act (42 U.S.C. 262).
(ii) Whether, and to what extent, an unmet
need related to the treatment or prevention of
a rare pediatric disease was met through the
approval or licensure of such a drug or
biological product.
(iii) The size of the company to which a
priority review voucher was awarded under
section 529 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360ff) for such a drug
or biological product.
(iv) The value of such priority review
voucher if transferred.
(v) Identification of each drug for which a
priority review voucher awarded under such
section 529 was used.
(vi) The size of the company using each
priority review voucher awarded under such
section 529.
(vii) The length of the period of time
between the date on which a priority review
voucher was awarded under such section 529 and
the date on which it was used.
(viii) Whether, and to what extent, an unmet
need related to the treatment or prevention of
a rare pediatric disease was met through the
approval under section 505 of the Federal Food,
Drug, and Cosmetic Act (42 U.S.C. 355) or
licensure under section 351 of the Public
Health Service Act (42 U.S.C. 262) of a drug
for which a priority review voucher was used.
(ix) Whether, and to what extent, companies
were motivated by the availability of priority
review vouchers under section 529 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360ff) to attempt to develop a drug for a rare
pediatric disease.
(x) Whether, and to what extent, pediatric
review vouchers awarded under such section were
successful in stimulating development and
expedited patient access to drug products for
treatment or prevention of a rare pediatric
disease that wouldn't otherwise take place
without the incentive provided by such
vouchers.
(xi) The impact of such priority review
vouchers on the workload, review process, and
public health prioritization efforts of the
Food and Drug Administration.
(xii) Any other incentives in Federal law
that exist for companies developing drugs or
biological products described in clause (i).
(2) Report on findings.--Not later than 5 years after the
date of the enactment of this Act, the Comptroller General of
the United States shall 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
containing the findings of the study conducted under paragraph
(1).
SEC. 6. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICENSURE OF ORPHAN DRUGS.
(a) In General.--Section 527 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360cc) is amended--
(1) in subsection (a), in the matter following paragraph (2),
by striking ``same disease or condition'' and inserting ``same
approved use or indication within such rare disease or
condition'';
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by
striking ``same rare disease or condition'' and
inserting ``same approved use or indication for which
such 7-year period applies to such already approved or
licensed drug''; and
(B) in paragraph (1), by inserting ``, relating to
the approved use or indication,'' after ``the needs'';
(3) in subsection (c)(1), by striking ``same rare disease or
condition as the already approved drug'' and inserting ``same
use or indication for which the already approved or licensed
drug was approved or licensed''; and
(4) by adding at the end the following:
``(f) Approved Use or Indication Defined.--In this section, the term
`approved use or indication' means the use or indication approved under
section 505 of this Act or licensed under section 351 of the Public
Health Service Act for a drug designated under section 526 for a rare
disease or condition.''.
(b) Application of Amendments.--The amendments made by subsection (a)
shall apply with respect to any drug designated under section 526 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regardless
of the date on which the drug was so designated, and regardless of the
date on which the drug was approved under section 505 of such Act (21
U.S.C. 355) or licensed under section 351 of the Public Health Service
Act (42 U.S.C. 262).
SEC. 7. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.
Section 409I(d)(1) of the Public Health Service Act (42 U.S.C.
284m(d)(1)) is amended by striking ``section,'' and all that follows
through the period at the end and inserting ``section, $25,000,000 for
each of fiscal years 2026 through 2028.''.
SEC. 8. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.
Section 372 of the Public Health Service Act (42 U.S.C. 274) is
amended--
(1) in subsection (b)(2)--
(A) by moving the margins of subparagraphs (M)
through (O) 2 ems to the left;
(B) in subparagraph (A)--
(i) in clause (i), by striking ``, and'' and
inserting ``; and''; and
(ii) in clause (ii), by striking the comma at
the end and inserting a semicolon;
(C) in subparagraph (C), by striking ``twenty-four-
hour telephone service'' and inserting ``24-hour
telephone or information technology service'';
(D) in each of subparagraphs (B) through (M), by
striking the comma at the end and inserting a
semicolon;
(E) in subparagraph (N), by striking
``transportation, and'' and inserting
``transportation;'';
(F) in subparagraph (O), by striking the period and
inserting a semicolon; and
(G) by adding at the end the following:
``(P) encourage the integration of electronic health
records systems through application programming
interfaces (or successor technologies) among hospitals,
organ procurement organizations, and transplant
centers, including the use of automated electronic
hospital referrals and the grant of remote, electronic
access to hospital electronic health records of
potential donors by organ procurement organizations, in
a manner that complies with the privacy regulations
promulgated under the Health Insurance Portability and
Accountability Act of 1996, at part 160 of title 45,
Code of Federal Regulations, and subparts A, C, and E
of part 164 of such title (or any successor
regulations); and
``(Q) consider establishing a dashboard to display
the number of transplants performed, the types of
transplants performed, the number and types of organs
that entered the Organ Procurement and Transplantation
Network system and failed to be transplanted, and other
appropriate statistics, which should be updated more
frequently than annually.''; and
(2) by adding at the end the following:
``(d) Registration Fees.--
``(1) In general.--The Secretary may collect registration
fees from any member of the Organ Procurement and
Transplantation Network for each transplant candidate such
member places on the list described in subsection (b)(2)(A)(i).
Such registration fees shall be collected and distributed only
to support the operation of the Organ Procurement and
Transplantation Network. Such registration fees are authorized
to remain available until expended.
``(2) Collection.--The Secretary may collect the registration
fees under paragraph (1) directly or through awards made under
subsection (b)(1)(A).
``(3) Distribution.--Any amounts collected under this
subsection shall--
``(A) be credited to the currently applicable
appropriation, account, or fund of the Department of
Health and Human Services as discretionary offsetting
collections; and
``(B) be available, only to the extent and in the
amounts provided in advance in appropriations Acts, to
distribute such fees among awardees described in
subsection (b)(1)(A).
``(4) Transparency.--The Secretary shall--
``(A) promptly post on the website of the Organ
Procurement and Transplantation Network--
``(i) the amount of registration fees
collected under this subsection from each
member of the Organ Procurement and
Transplantation Network; and
``(ii) a list of activities such fees are
used to support; and
``(B) update the information posted pursuant to
subparagraph (A), as applicable for each calendar
quarter for which fees are collected under paragraph
(1).
``(5) GAO review.--Not later than 2 years after the date of
enactment of this subsection, the Comptroller General of the
United States shall, to the extent data are available--
``(A) conduct a review concerning the activities
under this subsection; and
``(B) submit to the Committee on Health, Education,
Labor, and Pensions and the Committee on Finance of the
Senate and the Committee on Energy and Commerce of the
House of Representatives, a report on such review,
including related recommendations, as applicable.
``(6) Sunset.--The authority to collect registration fees
under paragraph (1) shall expire on the date that is 3 years
after the date of enactment of the Give Kids a Chance Act of
2025.''.
SEC. 9. ESTABLISHMENT OF ABRAHAM ACCORDS OFFICE WITHIN FOOD AND DRUG
ADMINISTRATION.
(a) In General.--Chapter X 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. 1015. ABRAHAM ACCORDS OFFICE.
``(a) In General.--The Secretary, acting through the Commissioner of
Food and Drugs, shall establish within the Food and Drug Administration
an office, to be known as the Abraham Accords Office, to be headed by a
director.
``(b) Office.--Not later than two years after the date of enactment
of this section, the Secretary shall--
``(1) in consultation with the governments of Abraham Accords
countries, as well as appropriate United States Government
diplomatic and security personnel--
``(A) select the location of the Abraham Accords
Office in an Abraham Accords country; and
``(B) establish such office; and
``(2) assign to such office such personnel of the Food and
Drug Administration as the Secretary determines necessary to
carry out the functions of such office.
``(c) Duties.--The Secretary, acting through the Director of the
Abraham Accords Office, shall--
``(1) after the Abraham Accords Office is established--
``(A) as part of the Food and Drug Administration's
work to strengthen the international oversight of
regulated commodities, provide technical assistance to
regulatory partners in Abraham Accords countries on
strengthening regulatory oversight and converging
regulatory requirements for the oversight of regulated
products, including good manufacturing practices and
other issues relevant to manufacturing medical products
that are regulated by the Food and Drug Administration;
and
``(B) facilitate interactions between the Food and
Drug Administration and interested parties in Abraham
Accords countries, including by sharing relevant
information regarding United States regulatory pathways
with such parties, and facilitate feedback on the
research, development, and manufacturing of products
regulated in accordance with this Act; and
``(2) carry out other functions and activities as the
Secretary determines to be necessary to carry out this section.
``(d) Abraham Accords Country Defined.--In this section, the term
`Abraham Accords country' means a country identified by the Department
of State as having signed the Abraham Accords Declaration.
``(e) National Security.--Nothing in this section shall be construed
to require any action inconsistent with a national security
recommendation provided by the Federal Government.''.
(b) Report to Congress.--
(1) In general.--Not later than 3 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall submit to the Congress a report on the Abraham
Accords Office, including--
(A) an evaluation of how the Office has advanced
progress toward conformance with Food and Drug
Administration regulatory requirements by manufacturers
in the Abraham Accords countries;
(B) a numerical count of parties that the Office has
helped facilitate interactions or feedback pursuant to
section 1015(c)(1)(B) of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a));
(C) a summary of technical assistance provided to
regulatory partners in Abraham Accords countries
pursuant to subparagraph (A) of such section
1015(c)(1); and
(D) recommendations for increasing and improving
coordination between the Food and Drug Administration
and entities in Abraham Accords countries.
(2) Abraham accords country defined.--In this subsection, the
term ``Abraham Accords country'' has the meaning given such
term in section 1015(d) of the Federal Food, Drug, and Cosmetic
Act (as added by subsection (a)).
SEC. 10. INCREASING TRANSPARENCY IN GENERIC DRUG APPLICATIONS.
(a) In General.--Section 505(j)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the
following:
``(H)(i) Upon request (in controlled correspondence or an analogous
process) by a person that has submitted or intends to submit an
abbreviated application under this subsection for a drug that is
required by regulation to contain one or more of the same inactive
ingredients in the same concentrations as the listed drug referred to,
or for which the Secretary determines there is a scientific
justification for an approach that is in vitro, in whole or in part, to
be used to demonstrate bioequivalence for a drug if such a drug
contains one or more of the same inactive ingredients in the same
concentrations as the listed drug referred to, the Secretary shall
inform the person whether such drug is qualitatively and quantitatively
the same as the listed drug. The Secretary may also provide such
information to such a person on the Secretary's own initiative during
the review of an abbreviated application under this subsection for such
drug.
``(ii) Notwithstanding section 301(j), if the Secretary determines
that such drug is not qualitatively or quantitatively the same as the
listed drug, the Secretary shall identify and disclose to the person--
``(I) the ingredient or ingredients that cause such drug not
to be qualitatively or quantitatively the same as the listed
drug; and
``(II) for any ingredient for which there is an identified
quantitative deviation, the amount of such deviation.
``(iii) If the Secretary determines that such drug is qualitatively
and quantitatively the same as the listed drug, the Secretary shall not
change or rescind such determination after the submission of an
abbreviated application for such drug under this subsection unless--
``(I) the formulation of the listed drug has been changed and
the Secretary has determined that the prior listed drug
formulation was withdrawn for reasons of safety or
effectiveness; or
``(II) the Secretary makes a written determination that the
prior determination must be changed because an error has been
identified.
``(iv) If the Secretary makes a written determination described in
clause (iii)(II), the Secretary shall provide notice and a copy of the
written determination to the person making the request under clause
(i).
``(v) The disclosures authorized under clauses (i) and (ii) are
disclosures authorized by law, including for purposes of section 1905
of title 18, United States Code. This subparagraph shall not otherwise
be construed to authorize the disclosure of nonpublic qualitative or
quantitative information about the ingredients in a listed drug, or to
affect the status, if any, of such information as trade secret or
confidential commercial information for purposes of section 301(j) of
this Act, section 552 of title 5, United States Code, or section 1905
of title 18, United States Code.''.
(b) Guidance.--
(1) In general.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue draft guidance, or update guidance,
describing how the Secretary will determine whether a drug is
qualitatively and quantitatively the same as the listed drug
(as such terms are used in section 505(j)(3)(H) of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a)),
including with respect to assessing pH adjusters.
(2) Process.--In issuing guidance under this subsection, the
Secretary of Health and Human Services shall--
(A) publish draft guidance;
(B) provide a period of at least 60 days for comment
on the draft guidance; and
(C) after considering any comments received and not
later than one year after the close of the comment
period on the draft guidance, publish final guidance.
(c) Applicability.--Section 505(j)(3)(H) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), applies beginning on the
date of enactment of this Act, irrespective of the date on which the
guidance required by subsection (b) is finalized.
SEC. 11. MEDICARE IMPROVEMENT FUND.
Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)) is amended--
(1) by striking ``fiscal year 2026'' and inserting ``fiscal
year 2027''; and
(2) by striking ``$1,804,000,000'' and inserting
``$3,047,000,000''.
Purpose and Summary
H.R. 1262 provides the Food and Drug Administration (FDA)
with additional authority to require pediatric cancer trials
for new combinations of drug therapies. The legislation also
authorizes the FDA to take enforcement action against companies
that fail to meet pediatric study requirements under the
Pediatric Research Equity Act (PREA) and requires the FDA to
report on enforcement of PREA. Additionally, the legislation
reauthorizes the FDA rare pediatric disease priority review
voucher (PRV) program through Fiscal Year 2029 and clarifies
that orphan drug exclusivity applies to the approved
indication, rather than the potentially broader designation.
This legislation also makes a technical correction to the
existing authorization of appropriations for the National
Institutes of Health (NIH) to fund studies of drugs in
children. In addition, this legislation allows the Secretary of
Health and Human Services (HHS) to collect registration fees
from members of the Organ Procurement and Transplantation
Network (OPTN) and distribute these fees to support the
operation of the OPTN for a period of 3 years. This legislation
also directs the FDA to establish an office in an Abraham
Accord country to enhance facilitation with the agency. Lastly,
this legislation requires FDA to disclose to certain generic
drug applicants what ingredients, if any, cause a drug to be
quantitatively or qualitatively different from the listed drug
for purposes of establishing sameness in formulation, and the
specific amount of the difference.
Background and Need for Legislation
Approximately 1,600 American children and adolescents die
each year from cancer and, in 2024, roughly 14,910 children and
adolescents were diagnosed with cancer.\1\ In recent years, the
5-year survival rates for most childhood cancers have
improved--between 1975 and 2022, the cancer mortality rate
among children and adolescents decreased from 5.1 per 100,000
children and adolescents to 2.2 per 100,000 children and
adolescents.\2\ Though cancer outcomes have generally improved,
the rate of improvement in survival has more recently slowed
and more than one-half of pediatric cancer survivors experience
serious long-term effects of their cancer and its therapy.\3\
In addition, there remain disparities between the outcomes and
cancer-related mortality across cancer types, ultimately
requiring more research and treatment development. Combination
therapy, a treatment method that utilizes two or more
therapeutic agents, is considered a cornerstone of cancer
therapy.\4\ Combination therapies are often more effective than
single agent therapy and demonstrate lower levels of toxicity
during long-term treatment.\5\ Currently, the FDA is only
authorized to require pediatric trials of single drug cancer
treatments.
---------------------------------------------------------------------------
\1\American Cancer Society, Cancer Facts & Figures 2024 (2024),
https://www.cancer.org/
content/dam/cancer-org/research/cancer-facts-and-statistics/annual-
cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf;
see also NATIONAL INSTITUTE OF HEALTH (NIH), National Cancer Institute,
Cancer in Children and Adolescents (Aug. 27, 2024), https://
www.cancer.gov/types/childhood-cancers/child-adolescent-cancers-fact-
sheet.
\2\NIH, National Cancer Institute, Cancer in Children and
Adolescents (Aug. 27, 2024), https://www.cancer.gov/types/childhood-
cancers/child-adolescent-cancers-fact-sheet.
\3\Erin Butler et al., ``Recent progress in the treatment of cancer
in children,'' American Cancer Society Journals, 2021, https://
acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21665.
\4\Rexa Bayat Mokhtari et al., Combination therapy in combating
cancer, Oncotarget (Mar. 30, 2017), https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC5514969/.
\5\Yiling Wang & Audrey Minden, Current Molecular Combination
Therapies Used for the Treatment of Breast Cancer, International
Journal of Molecular Sciences (Sept. 20, 2022), https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC9569555/
#::text=Recently%2C%20combination%20
therapies%20%28in%20which%20two%20or%20more,demonstrate%20lower%20levels
%20of%20 toxicity%20during%20long-term%20treatment.
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In addition, roughly 15 million American children are
living with a rare disease, yet 95 percent of rare diseases do
not have an FDA-approved treatment.\6\ The FDA rare pediatric
disease priority review voucher (PRV) program, which sunset
after December 20, 2024, aims to incentivize drug development
of treatments and cures for rare pediatric diseases by awarding
a priority review voucher for a qualifying drug or biological
product that targets a rare pediatric disease.\7\ Since the
program was first authorized in 2012, there have been over 60
PRVs awarded to sponsors that developed treatments for
pediatric rare diseases.\8\
---------------------------------------------------------------------------
\6\National Organization for Rare Disorders (NORD), Congress:
Reauthorize the Rare Pediatric Disease Priority Review Voucher Program
(Jul. 23, 2024), https://rarediseases.org/rare-pediatric-disease-prv-
program/.
\7\U.S. FOOD AND DRUG ADMINISTRATION, Rare Pediatric Disease
Designation and Priority Review Voucher Programs (Sept. 27, 2024),
https://www.fda.gov/industry/medical-products-rare-diseases-and-
conditions/rare-pediatric-disease-designation-and-priority-review-
voucher-
programs.
\8\Between 2012 and August 28, 2025, there have been a total of 48
Rare Pediatric Disease (RPD) PRVs issued through FDA's Center for Drug
Evaluation and Research and a total of 13 RPD PRVs issued through FDA's
Center for Biologics Evaluation and Research and published on the
Federal Register. See Notice, 79 Fed. Reg. 14055 (Mar. 12, 2014); see
also 80 Fed. Reg. 18628 (Apr. 7, 2015); 80 Fed. Reg. 18628 (Apr. 7,
2015); 80 Fed. Reg. 58489 (Sept. 29, 2015); 80 Fed. Reg. 71811 (Nov.
17, 2015); 81 Fed. Reg. 71511 (Oct. 17, 2016); 82 Fed. Reg. 12614 (Mar.
6, 2017); 82 Fed. Reg. 19052 (Apr. 25, 2017); 82 Fed. Reg. 28860 (Jun.
26, 2017); 82 Fed. Reg. 42686 (Sept. 11, 2017); 82 Fed. Reg. 59622
(Dec. 15, 2017); 83 Fed. Reg. 125 (Jan. 2, 2018); 83 Fed. Reg. 34139
(Jul. 19, 2018); 83 FR 40524 (Aug. 15, 2018); 83 Fed. Reg. 53880 (Oct.
25, 2018); 83 Fed. Reg. 64133 (Dec. 13, 2018); 84 Fed. Reg. 11985 (Mar.
29, 2019); 84 Fed. Reg. 29520 (Jun. 24, 2019); 84 Fed. Reg. 31324 (Jul.
1, 2019); 85 Fed. Reg. 3935 (Jan. 23, 2020); 85 Fed. Reg. 52354 (Aug.
25, 2020); 85 Fed. Reg. 55304 (Sept. 4, 2020); 85 Fed. Reg. 57217
(Sept. 15, 2020); 85 Fed. Reg. 57864 (Sept. 16, 2020); 85 Fed. Reg.
78859 (Dec. 7, 2020); 85 Fed. Reg. 81929 (Dec. 17, 2020); 85 Fed. Reg.
81933 (Dec. 17, 2020); 86 Fed. Reg. 9514 (Feb. 16, 2021); 86 Fed. Reg.
14125 (Mar. 12, 2021); 86 Fed. Reg. 14130 (Mar. 12, 2021); 86 Fed. Reg.
35307 (Jul. 2, 2021); 86 Fed. Reg. 59405 (Oct. 27, 2021); 87 Fed. Reg.
52782 (Aug. 29, 2022); 87 Fed. Reg. 54515 (Sept. 6, 2022); 87 Fed. Reg.
54700 (Sept. 7, 2022); 87 Fed. Reg. 61090 (Oct. 7, 2022); 87 Fed. Reg.
61090 (Oct. 7, 2022); 88 Fed. Reg. 16266 (Mar. 16, 2023); 88 Fed. Reg.
16274 (Mar. 16, 2023); 88 Fed. Reg. 19150 (Mar. 30, 2023); 88 Fed. Reg.
24806 (Apr. 24, 2023); 88 Fed. Reg. 37068 (Jun. 6, 2023); 88 Fed. Reg.
45430 (Jul. 17, 2023); 88 Fed. Reg. 61598 (Sept. 7, 2023); 88 Fed. Reg.
61600 (Sept. 7, 2023); 88 Fed. Reg. 84337 (Dec. 5, 2023); 89 Fed. Reg.
1097 (Jan. 9, 2024); 89 Fed. Reg. 1924 (Jan. 11, 2024); 89 Fed. Reg.
1925 (Jan. 11, 2024); 89 Fed. Reg. 25634 (Apr. 11, 2024); 89 Fed. Reg.
27767 (Apr. 18, 2024); 89 Fed. Reg. 42472 (May 15, 2024); 89 Fed. Reg.
42888 (May 16, 2024); 89 Fed. Reg. 68909 (Aug. 28, 2024); 89 Fed. Reg.
83023 (Oct. 15, 2024); 89 Fed. Reg. 83020 (Oct. 15, 2024); 89 Fed. Reg.
95219 (Dec. 2, 2024); 90 Fed. Reg. 2008 (Jan. 10, 2025); 90 Fed. Reg.
3880 (Jan. 15, 2025); 90 Fed. Reg. 11992 (Mar. 13, 2025); and 90 Fed.
Reg. 42018 (Aug. 28, 2025).
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In addition, FDA currently requires certain formulations of
generic medicines to demonstrate qualitative and quantitative
sameness of inactive ingredients with their brand-name
reference product. Generic drug developers often lack
information about these inactive ingredients, which can result
in inefficiencies in agency review, slower approvals, and
delayed access of generic drugs for patients.
By extending FDA's authority to require completion of
pediatric studies of combination therapies, as well as
clarifying that Orphan Drug Exclusivity only applies to the
same approved use or indication within such rare disease or
condition, as opposed to the entire disease or condition,
reauthorizing the rare pediatric disease priority review
voucher (PRV) program, providing a technical correction to the
authorization of appropriations to support efforts at the NIH
to research and improve the safety and efficacy of medication
use for children, and establishing an FDA office in an Abraham
Accords country to facilitate innovation, the Give Kids a
Chance Act of 2025 seeks to accelerate the development of
novel, safe, and effective treatments and improve outcomes for
pediatric cancer and rare pediatric diseases. Further, allowing
the Department of Health and Human Services (HHS) to collect
and distribute registration fees itself to support the OPTN
operations, as well as increasing transparency and reducing
burdens related to generic drug approvals, will continue our
shared missions to increase organ transplant rates and improve
access to timely, cost-efficient treatments, respectively--
ultimately leading to improved health outcomes.
Committee Action
On June 24, 2025, the Subcommittee on Health held a hearing
related to H.R. 1262. The title of the hearing was ``The Fiscal
Year 2026 Department of Health and Human Services Budget.'' The
Subcommittee received testimony from:
The Honorable Robert F. Kennedy, Jr.,
Secretary, U.S. Department of Health and Human
Services.
On September 17, 2025, the full Committee on Energy and
Commerce met in open markup session and ordered H.R. 1262, as
amended, favorably reported to the House by a record vote of 47
yeas and 0 nays.
Committee Votes
Clause 3(b) of rule XIII requires the Committee to list the
record votes on the motion to report legislation and amendments
thereto. The following reflects the record votes taken during
the Committee consideration:
Oversight Findings and Recommendations
Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of
rule XIII, the Committee held a hearing and made findings that
are reflected in this report.
New Budget Authority, Entitlement Authority,
and Tax Expenditures
Pursuant to clause 3(c)(2) of rule XIII, the Committee
finds that H.R. 1262 would result in no new or increased budget
authority, entitlement authority, or tax expenditures or
revenues.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII, at the time this
report was filed, the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974 was not available.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to expand
FDA authority related to pediatric cancer and rare disease
research and development, allow the Secretary of Health and
Human Services (HHS) to collect registration fees from OPTN
members to support the operation of the OPTN, and increase
access to generic drugs.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 1262 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
Related Committee and Subcommittee Hearings
Pursuant to clause 3(c)(6) of rule XIII, the following
related hearing was used to develop or consider H.R. 1262:
On June 24, 2025, the Subcommittee on Health
held a hearing related to H.R. 1262. The title of the
hearing was ``The Fiscal Year 2026 Department of Health
and Human Services Budget.'' The Subcommittee received
testimony from:
The Honorable Robert F. Kennedy,
Jr., Secretary, U.S. Department of Health and
Human Services.
Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974. At the time this report was
filed, the estimate was not available.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 1262 contains no earmarks, limited
tax benefits, or limited tariff benefits.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title; table of contents
Section 1 provides a short title of ``Give Kids a Chance
Act of 2025'' and the table of contents for this Act.
Section 2. Research into pediatric uses of drugs; additional
authorities of Food and Drug Administration regarding
molecularly targeted cancer drugs
Section 2 provides the Food and Drug Administration (FDA)
the authority to require pediatric cancer trials for new drugs
that are used in combination with active ingredients that meet
the standard of care for targeting pediatric cancer or have
been approved to treat adult cancer and are directed at
molecular targets for pediatric cancer. It would also require
the Government Accountability Office (GAO) to conduct a study
and report to Congress on the effectiveness of the requirements
outlined in this section in the development of drugs and
biological products for pediatric cancer indications.
Section 3. Ensuring completion of pediatric study requirements
Section 3 provides the FDA the authority to enforce against
companies that fail to meet pediatric study requirements. The
Secretary of the Department of Health and Human Services shall
perform due diligence before concluding failure to meet
requirements.
Section 4. FDA report on PREA enforcement
Section 4 requires the FDA to report on enforcement of the
Pediatric Research Equity Act (PREA).
Section 5. Extension of authority to issue priority review vouchers to
encourage treatments for rare pediatric diseases
Section 5 extends the FDA priority review voucher program
through September 30, 2029, to incentivize the development of
drugs for rare pediatric diseases. It also requires a study
from the GAO on the effectiveness of the pediatric PRV program.
Section 6. Limitations on exclusive approval of licensure of orphan
drugs
Section 6 clarifies that orphan drug exclusivity applies to
the approved indication, rather than the potentially broader
designation, in alignment with the FDA's interpretation.
Section 7. Program for pediatric studies of drugs
Section 7 makes a technical correction to the existing
authorization of appropriations for the National Institutes of
Health (NIH) to research studies of drugs in children.
Section 8. Organ Procurement and Transplantation Network
Section 8 allows the Secretary of Health and Human Services
to collect registration fees from any member of the Organ
Procurement Transplantation Network (OPTN) for each transplant
candidate such member places on the list and distribute these
fees to support the operation of OPTN, for a period of 3 years.
Section 9. Establishment of Abraham Accords Office within Food and Drug
Administration
Section 9 would require the Food and Drug Administration to
establish an office in an Abraham Accords country to enhance
facilitation with the agency and require the Secretary of
Health and Human Services to submit a report to Congress to
evaluate the office's progress.
Section 10. Increasing transparency in generic drug applications
Section 10 requires FDA to disclose to certain formulations
of generic drug applicants what ingredients, if any, cause a
drug to be quantitatively or qualitatively different from the
listed drug for purposes of establishing sameness in
formulation, and the specific amount of the difference.
Section 11. Medicare Improvement Fund
Section 11 adjusts the amount of funding in the Medicare
Improvement Fund from $1.804 billion to $3.047 billion.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, and existing law in which no
change is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER III--PROHIBITED ACTS AND PENALTIES
* * * * * * *
penalties
Sec. 303. (a)(1) Any person who violates a provision of
section 301 shall be imprisoned for not more than one year or
fined not more than $1,000, or both.
(2) Notwithstanding the provisions of paragraph (1) of this
section, if any person commits such a violation after a
conviction of him under this section has become final, or
commits such a violation with the intent to defraud or mislead,
such person shall be imprisoned for not more than three years
or fined not more than $10,000 or both.
(b)(1) Notwithstanding subsection (a), any person who
violates section 301(t) by--
(A) knowingly importing a drug in violation of
section 801(d)(1),
(B) knowingly selling, purchasing, or trading a drug
or drug sample or knowingly offering to sell, purchase,
or trade a drug or drug sample, in violation of section
503(c)(1),
(C) knowingly selling, purchasing, or trading a
coupon, knowingly offering to sell, purchase, or trade
such a coupon, or knowingly counterfeiting such a
coupon, in violation of section 503(c)(2), or
(D) knowingly distributing drugs in violation of
section 503(e)(1),
shall be imprisoned for not more than 10 years or fined not
more than $250,000, or both.
(2) Any manufacturer or distributor who distributes drug
samples by means other than the mail or common carrier whose
representative, during the course of the representative's
employment or association with that manufacturer or
distributor, violated section 301(t) because of a violation of
section 503(c)(1) or violated any State law prohibiting the
sale, purchase, or trade of a drug sample subject to section
503(b) or the offer to sell, purchase, or trade such a drug
sample shall, upon conviction of the representative for such
violation, be subject to the following civil penalties:
(A) A civil penalty of not more than $50,000 for each
of the first two such violations resulting in a
conviction of any representative of the manufacturer or
distributor in any 10-year period.
(B) A civil penalty of not more than $1,000,000 for
each violation resulting in a conviction of any
representative after the second conviction in any 10-
year period.
For the purposes of this paragraph, multiple convictions of one
or more persons arising out of the same event or transaction,
or a related series of events or transactions, shall be
considered as one violation.
(3) Any manufacturer or distributor who violates section
301(t) because of a failure to make a report required by
section 503(d)(3)(E) shall be subject to a civil penalty of not
more than $100,000.
(4)(A) If a manufacturer or distributor or any representative
of such manufacturer or distributor provides information
leading to the institution of a criminal proceeding against,
and conviction of, any representative of that manufacturer or
distributor for a violation of section 301(t) because of a
sale, purchase, or trade or offer to purchase, sell, or trade a
drug sample in violation of section 503(c)(1) or for a
violation of State law prohibiting the sale, purchase, or trade
or offer to sell, purchase, or trade a drug sample, the
conviction of such representative shall not be considered as a
violation for purposes of paragraph (2).
(B) If, in an action brought under paragraph (2) against a
manufacturer or distributor relating to the conviction of a
representative of such manufacturer or distributor for the
sale, purchase, or trade of a drug or the offer to sell,
purchase, or trade a drug, it is shown, by clear and convincing
evidence--
(i) that the manufacturer or distributor conducted,
before the institution of a criminal proceeding against
such representative for the violation which resulted in
such conviction, an investigation of events or
transactions which would have led to the reporting of
information leading to the institution of a criminal
proceeding against, and conviction of, such
representative for such purchase, sale, or trade or
offer to purchase, sell, or trade, or
(ii) that, except in the case of the conviction of a
representative employed in a supervisory function,
despite diligent implementation by the manufacturer or
distributor of an independent audit and security system
designed to detect such a violation, the manufacturer
or distributor could not reasonably have been expected
to have detected such violation,
the conviction of such representative shall not be considered
as a conviction for purposes of paragraph (2).
(5) If a person provides information leading to the
institution of a criminal proceeding against, and conviction
of, a person for a violation of section 301(t) because of the
sale, purchase, or trade of a drug sample or the offer to sell,
purchase, or trade a drug sample in violation of section
503(c)(1), such person shall be entitled to one-half of the
criminal fine imposed and collected for such violation but not
more than $125,000.
(6) Notwithstanding subsection (a), any person who is a
manufacturer or importer of a prescription drug under section
804(b) and knowingly fails to comply with a requirement of
section 804(e) that is applicable to such manufacturer or
importer, respectively, shall be imprisoned for not more than
10 years or fined not more than $250,000, or both.
(7) Notwithstanding subsection (a)(2), any person that
knowingly and intentionally adulterates a drug such that the
drug is adulterated under subsection (a)(1), (b), (c), or (d)
of section 501 and has a reasonable probability of causing
serious adverse health consequences or death to humans or
animals shall be imprisoned for not more than 20 years or fined
not more than $1,000,000, or both.
(8) Notwithstanding subsection (a), any person who violates
section 301(i)(3) by knowingly making, selling or dispensing,
or holding for sale or dispensing, a counterfeit drug, or who
violates section 301(fff)(3) by knowingly making, selling or
dispensing, or holding for sale or dispensing, a counterfeit
device, shall be imprisoned for not more than 10 years or fined
in accordance with title 18, United States Code, or both.
(c) No person shall be subject to the penalties of subsection
(a)(1) of this section, (1) for having received in interstate
commerce any article and delivered it or proffered delivery of
it, if such delivery or proffer was made in good faith, unless
he refuses to furnish on request of an officer or employee duly
designated by the Secretary the name and address of the person
from whom he purchased or received such article and copies of
all documents, if any there be, pertaining to the delivery of
the article to him; or (2) for having violated section 301(a)
or (d), if he establishes a guaranty or undertaking signed by,
and containing the name and address of, the person residing in
the United States from whom he received in good faith the
article, to the effect, in case of an alleged violation of
section 301(a), that such article is not adulterated or
misbranded, within the meaning of this Act, designating this
Act, or to the effect, in case of an alleged violation of
section 301(d), that such article is not an article which may
not, under the provisions of section 404 or 505, be introduced
into interstate commerce; or (3) for having violated section
301(a), where the violation exists because the article is
adulterated by reason of containing a color additive not from a
batch certified in accordance with regulations promulgated by
the Secretary under this Act, if such person establishes a
guaranty or undertaking signed by, and containing the name and
address of, the manufacturer of the color additive, to the
effect that such color additive was from a batch certified in
accordance with the applicable regulations promulgated by the
Secretary under this Act; or (4) for having violated section
301 (b), (c), or (k) by failure to comply with section 502(f)
in respect to an article received in interstate commerce to
which neither section 503(a) nor section 503(b)(1) is
applicable, if the delivery or proffered delivery was made in
good faith and the labeling at the time thereof contained the
same directions for use and warning statements as were
contained in the labeling at the time of such receipt of such
article; or (5) for having violated section 301(i)(2) if such
person acted in good faith and had no reason to believe that
use of the punch, die, plate, stone, or other thing involved
would result in a drug being a counterfeit drug, or for having
violated section 301(i)(3) if the person doing the act or
causing it to be done acted in good faith and had no reason to
believe that the drug was a counterfeit drug; or (6) for having
violated section 301(fff)(2) if such person acted in good faith
and had no reason to believe that use of the punch, die, plate,
stone, or other thing involved would result in a device being a
counterfeit device, or for having violated section 301(fff)(3)
if the person doing the act or causing it to be done acted in
good faith and had no reason to believe that the device was a
counterfeit device.
(d) No person shall be subject to the penalties of subsection
(a)(1) of this section for a violation of section 301 involving
misbranded food if the violation exists solely because the food
is misbranded under section 403(a)(2) because of its
advertising.
(e)(1) Except as provided in paragraph (2), whoever knowingly
distributes, or possesses with intent to distribute, human
growth hormone for any use in humans other than the treatment
of a disease or other recognized medical condition, where such
use has been authorized by the Secretary of Health and Human
Services under section 505 and pursuant to the order of a
physician, is guilty of an offense punishable by not more than
5 years in prison, such fines as are authorized by title 18,
United States Code, or both.
(2) Whoever commits any offense set forth in paragraph (1)
and such offense involves an individual under 18 years of age
is punishable by not more than 10 years imprisonment, such
fines as are authorized by title 18, United States Code, or
both.
(3) Any conviction for a violation of paragraphs (1) and (2)
of this subsection shall be considered a felony violation of
the Controlled Substances Act for the purposes of forfeiture
under section 413 of such Act.
(4) As used in this subsection the term ``human growth
hormone'' means somatrem, somatropin, or an analogue of either
of them.
(5) The Drug Enforcement Administration is authorized to
investigate offenses punishable by this subsection.
(f)(1)(A) Except as provided in subparagraph (B), any person
who violates a requirement of this Act which relates to devices
shall be liable to the United States for a civil penalty in an
amount not to exceed $15,000 for each such violation, and not
to exceed $1,000,000 for all such violations adjudicated in a
single proceeding. For purposes of the preceding sentence, a
person accredited under paragraph (2) of section 704(g) who is
substantially not in compliance with the standards of
accreditation under such section, or who poses a threat to
public health or fails to act in a manner that is consistent
with the purposes of such section, shall be considered to have
violated a requirement of this Act that relates to devices.
(B) Subparagraph (A) shall not apply--
(i) to any person who violates the requirements of
section 519(a) or 520(f) unless such violation
constitutes (I) a significant or knowing departure from
such requirements, or (II) a risk to public health,
(ii) to any person who commits minor violations of
section 519(e) or 519(g) (only with respect to
correction reports) if such person demonstrates
substantial compliance with such section, or
(iii) to violations of section 501(a)(2)(A) which
involve one or more devices which are not defective.
(2)(A) Any person who introduces into interstate commerce or
delivers for introduction into interstate commerce an article
of food that is adulterated within the meaning of section
402(a)(2)(B) or any person who does not comply with a recall
order under section 423 shall be subject to a civil money
penalty of not more than $50,000 in the case of an individual
and $250,000 in the case of any other person for such
introduction or delivery, not to exceed $500,000 for all such
violations adjudicated in a single proceeding.
(B) This paragraph shall not apply to any person who grew the
article of food that is adulterated. If the Secretary assesses
a civil penalty against any person under this paragraph, the
Secretary may not use the criminal authorities under this
section to sanction such person for the introduction or
delivery for introduction into interstate commerce of the
article of food that is adulterated. If the Secretary assesses
a civil penalty against any person under this paragraph, the
Secretary may not use the seizure authorities of section 304 or
the injunction authorities of section 302 with respect to the
article of food that is adulterated.
(C) In a hearing to assess a civil penalty under this
paragraph, the presiding officer shall have the same authority
with regard to compelling testimony or production of documents
as a presiding officer has under section 408(g)(2)(B). The
third sentence of paragraph (5)(A) shall not apply to any
investigation under this paragraph.
(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.
(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] 505-1, or 505B 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.
(5)(A) A civil penalty under paragraph (1), (2), (3), (4), or
(9) shall be assessed, or a no-tobacco-sale order may be
imposed, by the Secretary by an order made on the record after
opportunity for a hearing provided in accordance with this
subparagraph and section 554 of title 5, United States Code.
Before issuing such an order, the Secretary shall give written
notice to the person to be assessed a civil penalty, or upon
whom a no-tobacco-sale order is to be imposed, under such order
of the Secretary's proposal to issue such order and provide
such person an opportunity for a hearing on the order. In the
course of any investigation, the Secretary may issue subpoenas
requiring the attendance and testimony of witnesses and the
production of evidence that relates to the matter under
investigation.
(B) In determining the amount of a civil penalty, or the
period to be covered by a no-tobacco-sale order, the Secretary
shall take into account the nature, circumstances, extent, and
gravity of the violation or violations and, with respect to the
violator, ability to pay, effect on ability to continue to do
business, any history of prior such violations, the degree of
culpability, and such other matters as justice may require. A
no-tobacco-sale order permanently prohibiting an individual
retail outlet from selling tobacco products shall include
provisions that allow the outlet, after a specified period of
time, to request that the Secretary compromise, modify, or
terminate the order.
(C) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty which may be assessed
under paragraph (1), (2), (3), (4), or (9). The amount of such
penalty, when finally determined, or the amount agreed upon in
compromise, may be deducted from any sums owing by the United
States to the person charged.
(D) The Secretary may compromise, modify, or terminate, with
or without conditions, any no-tobacco-sale order.
(6) Any person who requested, in accordance with paragraph
(5)(A), a hearing respecting the assessment of a civil penalty
or the imposition of a no-tobacco-sale order and who is
aggrieved by an order assessing a civil penalty or the
imposition of a no-tobacco-sale order may file a petition for
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 assessment was
issued, or on which the no-tobacco-sale order was imposed, as
the case may be.
(7) If any person fails to pay an assessment of a civil
penalty--
(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 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.
(8) If the Secretary finds that a person has committed
repeated violations of section 906(d)(5) or of restrictions
promulgated under section 906(d) at a particular retail outlet
then the Secretary may impose a no-tobacco-sale order on that
person prohibiting the sale of tobacco products in that outlet.
A no-tobacco-sale order may be imposed with a civil penalty
under paragraph (1). Prior to the entry of a no-sale order
under this paragraph, a person shall be entitled to a hearing
pursuant to the procedures established through regulations of
the Food and Drug Administration for assessing civil money
penalties, including at a retailer's request a hearing by
telephone, or at the nearest regional or field office of the
Food and Drug Administration, or at a Federal, State, or county
facility within 100 miles from the location of the retail
outlet, if such a facility is available.
(9) Civil Monetary Penalties for Violation of Tobacco Product
Requirements.--
(A) In general.--Subject to subparagraph (B), any
person who violates a requirement of this Act which
relates to tobacco products shall be liable to the
United States for a civil penalty in an amount not to
exceed $15,000 for each such violation, and not to
exceed $1,000,000 for all such violations adjudicated
in a single proceeding.
(B) Enhanced penalties.--
(i) Any person who intentionally violates a
requirement of section 902(5), 902(6), 904,
908(c), or 911(a), shall be subject to a civil
monetary penalty of--
(I) not to exceed $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 such person, $250,000
for the first 30-day period (or any
portion thereof) that the 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.
(ii) Any person who violates a requirement of
section 911(g)(2)(C)(ii) or 911(i)(1), shall be
subject to a civil monetary penalty of--
(I) not to exceed $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 such person, $250,000
for the first 30-day period (or any
portion thereof) that the 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.
(iii) In determining the amount of a civil
penalty under clause (i)(II) or (ii)(II), the
Secretary shall take into consideration whether
the person is making efforts toward correcting
the violation of the requirements of the
section for which such person is subject to
such civil penalty.
(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.
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
* * * * * * *
new drugs
Sec. 505. (a) No person shall introduce or deliver for
introduction into interstate commerce any new drug, unless an
approval of an application filed pursuant to subsection (b) or
(j) is effective with respect to such drug.
(b)
(b)(1)(A) Any person may file with the Secretary an
application with respect to any drug subject to the provisions
of subsection (a). Such persons shall submit to the Secretary
as part of the application--
(i) full reports of investigations which have been
made to show whether such drug is safe for use and
whether such drug is effective in use;
(ii) a full list of the articles used as components
of such drug;
(iii) a full statement of the composition of such
drug;
(iv) a full description of the methods used in, and
the facilities and controls used for, the manufacture,
processing, and packing of such drug;
(v) such samples of such drug and of the articles
used as components thereof as the Secretary may
require;
(vi) specimens of the labeling proposed to be used
for such drug;
(vii) any assessments required under section 505B;
and
(viii) the patent number and expiration date of each
patent for which a claim of patent infringement could
reasonably be asserted if a person not licensed by the
owner of the patent engaged in the manufacture, use, or
sale of the drug, and that--
(I) claims the drug for which the applicant
submitted the application and is a drug
substance (active ingredient) patent or a drug
product (formulation or composition) patent; or
(II) claims a method of using such drug for
which approval is sought or has been granted in
the application.
(B) If an application is filed under this subsection for a
drug, and a patent of the type described in subparagraph
(A)(viii) is issued after the filing date but before approval
of the application, the applicant shall amend the application
to include the patent number and expiration date.
(2) An application submitted under paragraph (1) for a drug
for which the investigations described in clause (A) of such
paragraph and relied upon by the applicant for approval of the
application were not conducted by or for the applicant and for
which the applicant has not obtained a right of reference or
use from the person by or for whom the investigations were
conducted shall also include--
(A) a certification, in the opinion of the applicant
and to the best of his knowledge, with respect to each
patent which claims the drug for which such
investigations were conducted or which claims a use for
such drug for which the applicant is seeking approval
under this subsection and for which information is
required to be filed under paragraph (1) or subsection
(c)--
(i) that such patent information has not been
filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will
expire, or
(iv) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new drug for which the application is
submitted; and
(B) if with respect to the drug for which
investigations described in paragraph (1)(A) were
conducted information was filed under paragraph (1) or
subsection (c) for a method of use patent which does
not claim a use for which the applicant is seeking
approval under this subsection, a statement that the
method of use patent does not claim such a use.
(3) Notice of opinion that patent is invalid or will not be
infringed.--
(A) Agreement to give notice.--An applicant that
makes a certification described in paragraph (2)(A)(iv)
shall include in the application a statement that the
applicant will give notice as required by this
paragraph.
(B) Timing of notice.--An applicant that makes a
certification described in paragraph (2)(A)(iv) shall
give notice as required under this paragraph--
(i) if the certification is in the
application, not later than 20 days after the
date of the postmark on the notice with which
the Secretary informs the applicant that the
application has been filed; or
(ii) if the certification is in an amendment
or supplement to the application, at the time
at which the applicant submits the amendment or
supplement, regardless of whether the applicant
has already given notice with respect to
another such certification contained in the
application or in an amendment or supplement to
the application.
(C) Recipients of notice.--An applicant required
under this paragraph to give notice shall give notice
to--
(i) each owner of the patent that is the
subject of the certification (or a
representative of the owner designated to
receive such a notice); and
(ii) the holder of the approved application
under this subsection for the drug that is
claimed by the patent or a use of which is
claimed by the patent (or a representative of
the holder designated to receive such a
notice).
(D) Contents of notice.--A notice required under this
paragraph shall--
(i) state that an application that contains
data from bioavailability or bioequivalence
studies has been submitted under this
subsection for the drug with respect to which
the certification is made to obtain approval to
engage in the commercial manufacture, use, or
sale of the drug before the expiration of the
patent referred to in the certification; and
(ii) include a detailed statement of the
factual and legal basis of the opinion of the
applicant that the patent is invalid or will
not be infringed.
(4)(A) An applicant may not amend or supplement an
application referred to in paragraph (2) to seek approval of a
drug that is a different drug than the drug identified in the
application as submitted to the Secretary.
(B) With respect to the drug for which such an application is
submitted, nothing in this subsection or subsection (c)(3)
prohibits an applicant from amending or supplementing the
application to seek approval of a different strength.
(5)(A) The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1) or under
section 351 of the Public Health Service Act, which shall
relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which
shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection or section 351 of the Public Health Service Act
if the sponsor or applicant makes a reasonable written request
for a meeting for the purpose of reaching agreement on the
design and size--
(i)(I) of clinical trials intended to form the
primary basis of an effectiveness claim; or
(II) in the case where human efficacy studies are not
ethical or feasible, of animal and any associated
clinical trials which, in combination, are intended to
form the primary basis of an effectiveness claim; or
(ii) with respect to an application for approval of a
biological product under section 351(k) of the Public
Health Service Act, of any necessary clinical study or
studies.
The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of the
clinical trials. Minutes of any such meeting shall be prepared
by the Secretary and made available to the sponsor or applicant
upon request.
(C) Any agreement regarding the parameters of the design and
size of clinical trials of a new drug under this paragraph that
is reached between the Secretary and a sponsor or applicant
shall be reduced to writing and made part of the administrative
record by the Secretary. Such agreement shall not be changed
after the testing begins, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing
division, that a substantial scientific issue essential
to determining the safety or effectiveness of the drug
has been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to the
sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant will be present and at
which the director will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by,
the field or compliance division personnel unless such field or
compliance division personnel demonstrate to the reviewing
division why such decision should be modified.
(F) No action by the reviewing division may be delayed
because of the unavailability of information from or action by
field personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe and
effective drug.
(G) For purposes of this paragraph, the reviewing division is
the division responsible for the review of an application for
approval of a drug under this subsection or section 351 of the
Public Health Service Act (including all scientific and medical
matters, chemistry, manufacturing, and controls).
(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)(1) Within one hundred and eighty days after the filing of
an application under subsection (b), or such additional period
as may be agreed upon by the Secretary and the applicant, the
Secretary shall either--
(A) approve the application if he then finds that
none of the grounds for denying approval specified in
subsection (d) applies, or
(B) give the applicant notice of an opportunity for a
hearing before the Secretary under subsection (d) on
the question whether such application is approvable. If
the applicant elects to accept the opportunity for
hearing by written request within thirty days after
such notice, such hearing shall commence not more than
ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an
expedited basis and the Secretary's order thereon shall
be issued within ninety days after the date fixed by
the Secretary for filing final briefs.
(2) Not later than 30 days after the date of approval of an
application submitted under subsection (b), the holder of the
approved application shall file with the Secretary the patent
number and the expiration date of any patent described in
subsection (b)(1)(A)(viii), except that a patent that is
identified as claiming a method of using such drug shall be
filed only if the patent claims a method of use approved in the
application. If a patent described in subsection
(b)(1)(A)(viii) is issued after the date of approval of an
application submitted under subsection (b), the holder of the
approved application shall, not later than 30 days after the
date of issuance of the patent, file the patent number and the
expiration date of the patent, except that a patent that claims
a method of using such drug shall be filed only if approval for
such use has been granted in the application. If the patent
information described in subsection (b) could not be filed with
the submission of an application under subsection (b) because
the application was filed before the patent information was
required under subsection (b) or a patent was issued after the
application was approved under such subsection, the holder of
an approved application shall file with the Secretary, the
patent number and the expiration date of any patent described
in subsection (b)(1)(A)(viii). If the holder of an approved
application could not file patent information under subsection
(b) because it was not required at the time the application was
approved, the holder shall file such information under this
subsection not later than thirty days after the date of the
enactment of this sentence, and if the holder of an approved
application could not file patent information under subsection
(b) because no patent of the type for which information is
required to be submitted in subsection (b)(1)(A)(viii) had been
issued when an application was filed or approved, the holder
shall file such information under this subsection not later
than thirty days after the date the patent involved is issued.
Upon the submission of patent information under this
subsection, the Secretary shall publish it. Patent
informationthat is not the type of patent information
requiredby subsection (b)(1)(A)(viii) shall not be submitted
underthis paragraph.
(3) The approval of an application filed under subsection (b)
which contains a certification required by paragraph (2) of
such subsection shall be made effective on the last applicable
date determined by applying the following to each certification
made under subsection (b)(2)(A):
(A) If the applicant only made a certification
described in clause (i) or (ii) of subsection (b)(2)(A)
or in both such clauses, the approval may be made
effective immediately.
(B) If the applicant made a certification described
in clause (iii) of subsection (b)(2)(A), the approval
may be made effective on the date certified under
clause (iii).
(C) If the applicant made a certification described
in clause (iv) of subsection (b)(2)(A), the approval
shall be made effective immediately unless, before the
expiration of 45 days after the date on which the
notice described in subsection (b)(3) is received, an
action is brought for infringement of the patent that
is the subject of the certification and for which
information was submitted to the Secretary under
paragraph (2) or subsection (b)(1) before the date on
which the application (excluding an amendment or
supplement to the application) was submitted. If such
an action is brought before the expiration of such
days, the approval may be made effective upon the
expiration of the thirty-month period beginning on the
date of the receipt of the notice provided under
subsection (b)(3) or such shorter or longer period as
the court may order because either party to the action
failed to reasonably cooperate in expediting the
action, except that--
(i) if before the expiration of such period
the district court decides that the patent is
invalid or not infringed (including any
substantive determination that there is no
cause of action for patent infringement or
invalidity), the approval shall be made
effective on--
(I) the date on which the court
enters judgment reflecting the
decision; or
(II) the date of a settlement order
or consent decree signed and entered by
the court stating that the patent that
is the subject of the certification is
invalid or not infringed;
(ii) if before the expiration of such period
the district court decides that the patent has
been infringed--
(I) if the judgment of the district
court is appealed, the approval shall
be made effective on--
(aa) the date on which the
court of appeals decides that
the patent is invalid or not
infringed (including any
substantive determination that
there is no cause of action for
patent infringement or
invalidity); or
(bb) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the patent
that is the subject of the
certification is invalid or not
infringed; or
(II) if the judgment of the district
court is not appealed or is affirmed,
the approval shall be made effective on
the date specified by the district
court in a court order under section
271(e)(4)(A) of title 35, United States
Code;
(iii) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent is invalid or not
infringed, the approval shall be made effective
as provided in clause (i); or
(iv) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent has been infringed,
the approval shall be made effective as
provided in clause (ii).
In such an action, each of the parties shall reasonably
cooperate in expediting the action.
(D) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement
action.--
(I) In general.--No action may be
brought under section 2201 of title 28,
United States Code, by an applicant
referred to in subsection (b)(2) for a
declaratory judgment with respect to a
patent which is the subject of the
certification referred to in
subparagraph (C) unless--
(aa) the 45-day period
referred to in such
subparagraph has expired;
(bb) neither the owner of
such patent nor the holder of
the approved application under
subsection (b) for the drug
that is claimed by the patent
or a use of which is claimed by
the patent brought a civil
action against the applicant
for infringement of the patent
before the expiration of such
period; and
(cc) in any case in which the
notice provided under paragraph
(2)(B) relates to
noninfringement, the notice was
accompanied by a document
described in subclause (III).
(II) Filing of civil action.--If the
conditions described in items (aa),
(bb), and as applicable, (cc) of
subclause (I) have been met, the
applicant referred to in such subclause
may, in accordance with section 2201 of
title 28, United States Code, bring a
civil action under such section against
the owner or holder referred to in such
subclause (but not against any owner or
holder that has brought such a civil
action against the applicant, unless
that civil action was dismissed without
prejudice) for a declaratory judgment
that the patent is invalid or will not
be infringed by the drug for which the
applicant seeks approval, except that
such civil action may be brought for a
declaratory judgment that the patent
will not be infringed only in a case in
which the condition described in
subclause (I)(cc) is applicable. A
civil action referred to in this
subclause shall be brought in the
judicial district where the defendant
has its principal place of business or
a regular and established place of
business.
(III) Offer of confidential access to
application.--For purposes of subclause
(I)(cc), the document described in this
subclause is a document providing an
offer of confidential access to the
application that is in the custody of
the applicant referred to in subsection
(b)(2) for the purpose of determining
whether an action referred to in
subparagraph (C) should be brought. The
document providing the offer of
confidential access shall contain such
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, as would
apply had a protective order been
entered for the purpose of protecting
trade secrets and other confidential
business information. A request for
access to an application under an offer
of confidential access shall be
considered acceptance of the offer of
confidential access with the
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, contained
in the offer of confidential access,
and those restrictions and other terms
of the offer of confidential access
shall be considered terms of an
enforceable contract. Any person
provided an offer of confidential
access shall review the application for
the sole and limited purpose of
evaluating possible infringement of the
patent that is the subject of the
certification under subsection
(b)(2)(A)(iv) and for no other purpose,
and may not disclose information of no
relevance to any issue of patent
infringement to any person other than a
person provided an offer of
confidential access. Further, the
application may be redacted by the
applicant to remove any information of
no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the
patent or the holder of the approved
application under subsection (b) for
the drug that is claimed by the patent
or a use of which is claimed by the
patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the holder
to correct or delete the patent
information submitted by the holder
under subsection (b) or this subsection
on the ground that the patent does not
claim either--
(aa) the drug for which the
application was approved; or
(bb) an approved method of
using the drug.
(II) No independent cause of
action.--Subclause (I) does not
authorize the assertion of a claim
described in subclause (I) in any civil
action or proceeding other than a
counterclaim described in subclause
(I).
(iii) No damages.--An applicant shall not be
entitled to damages in a civil action under
clause (i) or a counterclaim under clause (ii).
(E)
(ii) If an application submitted under subsection (b)
for a drug, no active moiety (as defined by the
Secretary in section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations)) of which
has been approved in any other application under
subsection (b), is approved after the date of the
enactment of this clause, no application which refers
to the drug for which the subsection (b) application
was submitted and for which the investigations
described in subsection (b)(1)(A)(i) and relied upon by
the applicant for approval of the application were not
conducted by or for the applicant and for which the
applicant has not obtained a right of reference or use
from the person by or for whom the investigations were
conducted may be submitted under subsection (b) before
the expiration of five years from the date of the
approval of the application under subsection (b),
except that such an application may be submitted under
subsection (b) after the expiration of four years from
the date of the approval of the subsection (b)
application if it contains a certification of patent
invalidity or noninfringement described in clause (iv)
of subsection (b)(2)(A). The approval of such an
application shall be made effective in accordance with
this paragraph except that, if an action for patent
infringement is commenced during the one-year period
beginning forty-eight months after the date of the
approval of the subsection (b) application, the thirty-
month period referred to in subparagraph (C) shall be
extended by such amount of time (if any) which is
required for seven and one-half years to have elapsed
from the date of approval of the subsection (b)
application.
(iii) If an application submitted under subsection
(b) for a drug, which includes an active moiety (as
defined by the Secretary in section 314.3 of title 21,
Code of Federal Regulations (or any successor
regulations)) that has been approved in another
application approved under subsection (b), is approved
after the date of the enactment of this clause and if
such application contains reports of new clinical
investigations (other than bioavailability studies)
essential to the approval of the application and
conducted or sponsored by the applicant, the Secretary
may not make the approval of an application submitted
under subsection (b) for the conditions of approval of
such drug in the approved subsection (b) application
effective before the expiration of three years from the
date of the approval of the application under
subsection (b) if the investigations described in
subsection (b)(1)(A)(i) and relied upon by the
applicant for approval of the application were not
conducted by or for the applicant and if the applicant
has not obtained a right of reference or use from the
person by or for whom the investigations were
conducted.
(iv) If a supplement to an application approved under
subsection (b) is approved after the date of enactment
of this clause and the supplement contains reports of
new clinical investigations (other than bioavailabilty
studies) essential to the approval of the supplement
and conducted or sponsored by the person submitting the
supplement, the Secretary may not make the approval of
an application submitted under subsection (b) for a
change approved in the supplement effective before the
expiration of three years from the date of the approval
of the supplement under subsection (b) if the
investigations described in subsection (b)(1)(A)(i) and
relied upon by the applicant for approval of the
application were not conducted by or for the applicant
and if the applicant has not obtained a right of
reference or use from the person by or for whom the
investigations were conducted.
(v) If an application (or supplement to an
application) submitted under subsection (b) for a drug,
which includes anactive moiety (as defined by the
Secretary in section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations)) that has
been approved in another application under subsection
(b), was approved during the period beginning January
1, 1982, and ending on the date of the enactment of
this clause, the Secretary may not make the approval of
an application submitted under this subsection and for
which the investigations described in subsection
(b)(1)(A)(i) and relied upon by the applicant for
approval of the application were not conducted by or
for the applicant and for which the applicant has not
obtained a right of reference or use from the person by
or for whom the investigations were conducted and which
refers to the drug for which the subsection (b)
application was submitted effective before the
expiration of two years from the date of enactment of
this clause.
(4) A drug manufactured in a pilot or other small facility
may be used to demonstrate the safety and effectiveness of the
drug and to obtain approval for the drug prior to manufacture
of the drug in a larger facility, unless the Secretary makes a
determination that a full scale production facility is
necessary to ensure the safety or effectiveness of the drug.
(5)(A) The Secretary may rely upon qualified data summaries
to support the approval of a supplemental application, with
respect to a qualified indication for a drug, submitted under
subsection (b), if such supplemental application complies with
subparagraph (B).
(B) A supplemental application is eligible for review as
described in subparagraph (A) only if--
(i) there is existing data available and acceptable
to the Secretary demonstrating the safety of the drug;
and
(ii) all data used to develop the qualified data
summaries are submitted to the Secretary as part of the
supplemental application.
(C) The Secretary shall post on the Internet website of the
Food and Drug Administration and update annually--
(i) the number of applications reviewed solely under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act;
(ii) the average time for completion of review under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act;
(iii) the average time for review of supplemental
applications where the Secretary did not use review
flexibility under subparagraph (A) or section
351(a)(2)(E) of the Public Health Service Act; and
(iv) the number of applications reviewed under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act for which the Secretary made use of
full data sets in addition to the qualified data
summary.
(D) In this paragraph--
(i) the term ``qualified indication'' means an
indication for a drug that the Secretary determines to
be appropriate for summary level review under this
paragraph; and
(ii) the term ``qualified data summary'' means a
summary of clinical data that demonstrates the safety
and effectiveness of a drug with respect to a qualified
indication.
(d) If the Secretary finds, after due notice to the applicant
in accordance with subsection (c) and giving him an opportunity
for a hearing, in accordance with said subsection, that (1) the
investigations, reports of which are required to be submitted
to the Secretary pursuant to subsection (b), do not include
adequate tests by all methods reasonably applicable to show
whether or not such drug is safe for use under the conditions
prescribed, recommended, or suggested in the proposed labeling
thereof; (2) the results of such tests show that such drug is
unsafe for use under such conditions or do not show that such
drug is safe for use under such conditions; (3) the methods
used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug are
inadequate to preserve its identity, strength, quality, and
purity; (4) upon the basis of the information submitted to him
as part of the application, or upon the basis of any other
information before him with respect to such drug, he has
insufficient information to determine whether such drug is safe
for use under such conditions; or (5) evaluated on the basis of
the information submitted to him as part of the application and
any other information before him with respect to such drug,
there is a lack of substantial evidence that the drug will have
the effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the
proposed labeling thereof; or (6) the application failed to
contain the patent information prescribed by subsection (b); or
(7) based on a fair evaluation of all material facts, such
labeling is false or misleading in any particular; he shall
issue an order refusing to approve the application. If, after
such notice and opportunity for hearing, the Secretary finds
that clauses (1) through (6) do not apply, he shall issue an
order approving the application. As used in this subsection and
subsection (e), the term ``substantial evidence'' means
evidence consisting of adequate and well-controlled
investigations, including clinical investigations, by experts
qualified by scientific training and experience to evaluate the
effectiveness of the drug involved, on the basis of which it
could fairly and responsibly be concluded by such experts that
the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof. If the
Secretary determines, based on relevant science, that data from
one adequate and well-controlled clinical investigation and
confirmatory evidence (obtained prior to or after such
investigation) are sufficient to establish effectiveness, the
Secretary may consider such data and evidence to constitute
substantial evidence for purposes of the preceding sentence.
The Secretary shall implement a structured risk-benefit
assessment framework in the new drug approval process to
facilitate the balanced consideration of benefits and risks, a
consistent and systematic approach to the discussion and
regulatory decisionmaking, and the communication of the
benefits and risks of new drugs. Nothing in the preceding
sentence shall alter the criteria for evaluating an application
for marketing approval of a drug.
(e) The Secretary shall, after due notice and opportunity for
hearing to the applicant, withdraw approval of an application
with respect to any drug under this section if the Secretary
finds (1) that clinical or other experience, tests, or other
scientific data show that such drug is unsafe for use under the
conditions of use upon the basis of which the application was
approved; (2) that new evidence of clinical experience, not
contained in such application or not available to the Secretary
until after such application was approved, or tests by new
methods, or tests by methods not deemed reasonably applicable
when such application was approved, evaluated together with the
evidence available to the Secretary when the application was
approved, shows that such drug is not shown to be safe for use
under the conditions of use upon the basis of which the
application was approved; or (3) on the basis of new
information before him with respect to such drug, evaluated
together with the evidence available to him when the
application was approved, that there is a lack of substantial
evidence that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed,
recommended, or suggested in the labeling thereof; or (4) the
patent information prescribed by subsection (c) was not filed
within thirty days after the receipt of written notice from the
Secretary specifying the failure to file such information; or
(5) that the application contains any untrue statement of a
material fact: Provided, That if the Secretary (or in his
absence the officer acting as Secretary) finds that there is an
imminent hazard to the public health, he may suspend the
approval of such application immediately, and give the
applicant prompt notice of his action and afford the applicant
the opportunity for an expedited hearing under this subsection;
but the authority conferred by this proviso to suspend the
approval of an application shall not be delegated. The
Secretary may also, after due notice and opportunity for
hearing to the applicant, withdraw the approval of an
application submitted under subsection (b) or (j) with respect
to any drug under this section if the Secretary finds (1) that
the applicant has failed to establish a system for maintaining
required records, or has repeatedly or deliberately failed to
maintain such records or to make required reports, in
accordance with a regulation or order under subsection (k) or
to comply with the notice requirements of section 510(k)(2), or
the applicant has refused to permit access to, or copying or
verification of, such records as required by paragraph (2) of
such subsection; or (2) that on the basis of new information
before him, evaluated together with the evidence before him
when the application was approved, the methods used in, or the
facilities and controls used for, the manufacture, processing,
and packing of such drug are inadequate to assure and preserve
its identity, strength, quality, and purity and were not made
adequate within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained of;
or (3) that on the basis of new information before him,
evaluated together with the evidence before him when the
application was approved, the labeling of such drug, based on a
fair evaluation of all material facts, is false or misleading
in any particular and was not corrected within a reasonable
time after receipt of written notice from the Secretary
specifying the matter complained of. Any order under this
subsection shall state the findings upon which it is based. 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).
(f) Whenever the Secretary finds that the facts so require,
he shall revoke any previous order under subsection (d) or (e)
refusing, withdrawing, or suspending approval of an application
and shall approve such application or reinstate such approval,
as may be appropriate.
(g) Orders of the Secretary issued under this section shall
be served (1) in person by any officer or employee of the
Department designated by the Secretary or (2) by mailing the
order by registered mail or by certified mail addressed to the
applicant or respondent at his last-known address in the
records of the Secretary.
(h) An appeal may be taken by the applicant from an order of
the Secretary refusing or withdrawing approval of an
application under this section. Such appeal shall be taken by
filing in the United States court of appeals for the circuit
wherein such applicant resides or has his principal place of
business, or in the United States Court of Appeals for the
District of Columbia Circuit, within sixty days after the entry
of such order, a written petition praying that the order of the
Secretary be set aside. A copy of such petition shall be
forthwith transmitted by the clerk of the court to the
Secretary, or any officer designated by him for that purpose,
and thereupon the Secretary shall certify and file in the court
the record upon which the order complained of was entered, as
provided in section 2112 of title 28, United States Code. Upon
the filing of such petition such court shall have exclusive
jurisdiction to affirm or set aside such order, except that
until the filing of the record the Secretary may modify or set
aside his order. No objection to the order of the Secretary
shall be considered by the court unless such objection shall
have been urged before the Secretary or unless there were
reasonable grounds for failure so to do. The finding of the
Secretary as to the facts, if supported by substantial
evidence, shall be conclusive. If any person shall apply to the
court for leave to adduce additional evidence, and shall show
to the satisfaction of the court that such additional evidence
is material and that there were reasonable grounds for failure
to adduce such evidence in the proceeding before the Secretary,
the court may order such additional evidence to be taken before
the Secretary and to be adduced upon the hearing in such manner
and upon such terms and conditions as to the court may seem
proper. The Secretary may modify his findings as to the facts
by reason of the additional evidence so taken, and he shall
file with the court such modified findings which, if supported
by substantial evidence, shall be conclusive, and his
recommendation, if any, for the setting aside of the original
order. The judgment of the court affirming or setting aside any
such order of the Secretary shall be final, subject to review
by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28 of the
United States Code. The commencement of proceedings under this
subsection shall not, unless specifically ordered by the court
to the contrary, operate as a stay of the Secretary's order.
(i)(1) The Secretary shall promulgate regulations for
exempting from the operation of the foregoing subsections of
this section drugs intended solely for investigational use by
experts qualified by scientific training and experience to
investigate the safety and effectiveness of drugs. Such
regulations may, within the discretion of the Secretary, among
other conditions relating to the protection of the public
health, provide for conditioning such exemption upon--
(A) the submission to the Secretary, before any
clinical testing of a new drug is undertaken, of
reports, by the manufacturer or the sponsor of the
investigation of such drug, or nonclinical tests of
such drug adequate to justify the proposed clinical
testing;
(B) the manufacturer or the sponsor of the
investigation of a new drug proposed to be distributed
to investigators for clinical testing obtaining a
signed agreement from each of such investigators that
patients to whom the drug is administered will be under
his personal supervision, or under the supervision of
investigators responsible to him, and that he will not
supply such drug to any other investigator, or to
clinics, for administration to human beings;
(C) the establishment and maintenance of such
records, and the making of such reports to the
Secretary, by the manufacturer or the sponsor of the
investigation of such drug, of data (including but not
limited to analytical reports by investigators)
obtained as the result of such investigational use of
such drug, as the Secretary finds will enable him to
evaluate the safety and effectiveness of such drug in
the event of the filing of an application pursuant to
subsection (b); and
(D) the submission to the Secretary by the
manufacturer or the sponsor of the
investigation of a new drug of a statement of
intent regarding whether the manufacturer or
sponsor has plans for assessing pediatric
safety and efficacy.
(2) Subject to paragraph (3), a clinical investigation of a
new drug may begin 30 days after the Secretary has received
from the manufacturer or sponsor of the investigation a
submission containing such information about the drug and the
clinical investigation, including--
(A) information on design of the investigation and
adequate reports of basic information, certified by the
applicant to be accurate reports, necessary to assess
the safety of the drug for use in clinical
investigation; and
(B) adequate information on the chemistry and
manufacturing of the drug, controls available for the
drug, and primary data tabulations from nonclinical
tests or human studies.
(3)(A) At any time, the Secretary may prohibit the sponsor of
an investigation from conducting the investigation (referred to
in this paragraph as a ``clinical hold'') if the Secretary
makes a determination described in subparagraph (B). The
Secretary shall specify the basis for the clinical hold,
including the specific information available to the Secretary
which served as the basis for such clinical hold, and confirm
such determination in writing.
(B) For purposes of subparagraph (A), a determination
described in this subparagraph with respect to a clinical hold
is that--
(i) the drug involved represents an unreasonable risk
to the safety of the persons who are the subjects of
the clinical investigation, taking into account the
qualifications of the clinical investigators,
information about the drug, the design of the clinical
investigation, the condition for which the drug is to
be investigated, and the health status of the subjects
involved; or
(ii) the clinical hold should be issued for such
other reasons as the Secretary may by regulation
establish (including reasons established by regulation
before the date of the enactment of the Food and Drug
Administration Modernization Act of 1997).
(C) Any written request to the Secretary from the sponsor of
an investigation that a clinical hold be removed shall receive
a decision, in writing and specifying the reasons therefor,
within 30 days after receipt of such request. Any such request
shall include sufficient information to support the removal of
such clinical hold.
(4) Regulations under paragraph (1) shall provide that such
exemption shall be conditioned upon the manufacturer, or the
sponsor of the investigation, requiring that experts using such
drugs for investigational purposes certify to such manufacturer
or sponsor that they will inform any human beings to whom such
drugs, or any controls used in connection therewith, are being
administered, or their representatives, that such drugs are
being used for investigational purposes and will obtain the
consent of such human beings or their representatives, except
where it is not feasible, it is contrary to the best interests
of such human beings, or the proposed clinical testing poses no
more than minimal risk to such human beings and includes
appropriate safeguards as prescribed to protect the rights,
safety, and welfare of such human beings. Nothing in this
subsection shall be construed to require any clinical
investigator to submit directly to the Secretary reports on the
investigational use of drugs. 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.
(j)(1) Any person may file with the Secretary an abbreviated
application for the approval of a new drug.
(2)(A) An abbreviated application for a new drug shall
contain--
(i) information to show that the conditions of use
prescribed, recommended, or suggested in the labeling
proposed for the new drug have been previously approved
for a drug listed under paragraph (7) (hereinafter in
this subsection referred to as a ``listed drug'');
(ii)(I) if the listed drug referred to in clause (i)
has only one active ingredient, information to show
that the active ingredient of the new drug is the same
as that of the listed drug;
(II) if the listed drug referred to in clause (i) has
more than one active ingredient, information to show
that the active ingredients of the new drug are the
same as those of the listed drug, or
(III) if the listed drug referred to in clause (i)
has more than one active ingredient and if one of the
active ingredients of the new drug is different and the
application is filed pursuant to the approval of a
petition filed under subparagraph (C), information to
show that the other active ingredients of the new drug
are the same as the active ingredients of the listed
drug, information to show that the different active
ingredient is an active ingredient of a listed drug or
of a drug which does not meet the requirements of
section 201(p), and such other information respecting
the different active ingredient with respect to which
the petition was filed as the Secretary may require;
(iii) information to show that the route of
administration, the dosage form, and the strength of
the new drug are the same as those of the listed drug
referred to in clause (i) or, if the route of
administration, the dosage form, or the strength of the
new drug is different and the application is filed
pursuant to the approval of a petition filed under
subparagraph (C), such information respecting the route
of administration, dosage form, or strength with
respect to which the petition was filed as the
Secretary may require;
(iv) information to show that the new drug is
bioequivalent to the listed drug referred to in clause
(i), except that if the application is filed pursuant
to the approval of a petition filed under subparagraph
(C), information to show that the active ingredients of
the new drug are of the same pharmacological or
therapeutic class as those of the listed drug referred
to in clause (i) and the new drug can be expected to
have the same therapeutic effect as the listed drug
when administered to patients for a condition of use
referred to in clause (i);
(v) information to show that the labeling proposed
for the new drug is the same as the labeling approved
for the listed drug referred to in clause (i) except
for changes required because of differences approved
under a petition filed under subparagraph (C) or
because the new drug and the listed drug are produced
or distributed by different manufacturers;
(vi) the items specified in clauses (ii) through (vi)
of subsection (b)(1)(A);
(vii) a certification, in the opinion of the
applicant and to the best of his knowledge, with
respect to each patent which claims the listed drug
referred to in clause (i) or which claims a use for
such listed drug for which the applicant is seeking
approval under this subsection and for which
information is required to be filed under subsection
(b) or (c)--
(I) that such patent information has not been
filed,
(II) that such patent has expired,
(III) of the date on which such patent will
expire, or
(IV) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new drug for which the application is
submitted; and
(viii) if with respect to the listed drug referred to
in clause (i) information was filed under subsection
(b) or (c) for a method of use patent which does not
claim a use for which the applicant is seeking approval
under this subsection, a statement that the method of
use patent does not claim such a use.
The Secretary may not require that an abbreviated application
contain information in addition to that required by clauses (i)
through (viii).
(B) Notice of opinion that patent is invalid or will not be
infringed.--
(i) Agreement to give notice.--An applicant that
makes a certification described in subparagraph
(A)(vii)(IV) shall include in the application a
statement that the applicant will give notice as
required by this subparagraph.
(ii) Timing of notice.--An applicant that makes a
certification described in subparagraph (A)(vii)(IV)
shall give notice as required under this subparagraph--
(I) if the certification is in the
application, not later than 20 days after the
date of the postmark on the notice with which
the Secretary informs the applicant that the
application has been filed; or
(II) if the certification is in an amendment
or supplement to the application, at the time
at which the applicant submits the amendment or
supplement, regardless of whether the applicant
has already given notice with respect to
another such certification contained in the
application or in an amendment or supplement to
the application.
(iii) Recipients of notice.--An applicant required
under this subparagraph to give notice shall give
notice to--
(I) each owner of the patent that is the
subject of the certification (or a
representative of the owner designated to
receive such a notice); and
(II) the holder of the approved application
under subsection (b) for the drug that is
claimed by the patent or a use of which is
claimed by the patent (or a representative of
the holder designated to receive such a
notice).
(iv) Contents of notice.--A notice required under
this subparagraph shall--
(I) state that an application that contains
data from bioavailability or bioequivalence
studies has been submitted under this
subsection for the drug with respect to which
the certification is made to obtain approval to
engage in the commercial manufacture, use, or
sale of the drug before the expiration of the
patent referred to in the certification; and
(II) include a detailed statement of the
factual and legal basis of the opinion of the
applicant that the patent is invalid or will
not be infringed.
(C) If a person wants to submit an abbreviated application
for a new drug which has a different active ingredient or whose
route of administration, dosage form, or strength differ from
that of a listed drug, such person shall submit a petition to
the Secretary seeking permission to file such an application.
The Secretary shall approve or disapprove a petition submitted
under this subparagraph within ninety days of the date the
petition is submitted. The Secretary shall approve such a
petition unless the Secretary finds--
(i) that investigations must be conducted to show the
safety and effectiveness of the drug or of any of its
active ingredients, the route of administration, the
dosage form, or strength which differ from the listed
drug; or
(ii) that any drug with a different active ingredient
may not be adequately evaluated for approval as safe
and effective on the basis of the information required
to be submitted in an abbreviated application.
(D)(i) An applicant may not amend or supplement an
application to seek approval of a drug referring to a different
listed drug from the listed drug identified in the application
as submitted to the Secretary.
(ii) With respect to the drug for which an application is
submitted, nothing in this subsection prohibits an applicant
from amending or supplementing the application to seek approval
of a different strength.
(iii) Within 60 days after the date of the enactment of the
Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, the Secretary shall issue guidance defining the term
``listed drug'' for purposes of this subparagraph.
(3)(A) The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1), which
shall relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which
shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection if the sponsor or applicant makes a reasonable
written request for a meeting for the purpose of reaching
agreement on the design and size of bioavailability and
bioequivalence studies needed for approval of such application.
The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of such
studies. Minutes of any such meeting shall be prepared by the
Secretary and made available to the sponsor or applicant.
(C) Any agreement regarding the parameters of design and size
of bioavailability and bioequivalence studies of a drug under
this paragraph that is reached between the Secretary and a
sponsor or applicant shall be reduced to writing and made part
of the administrative record by the Secretary. Such agreement
shall not be changed after the testing begins, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing
division, that a substantial scientific issue essential
to determining the safety or effectiveness of the drug
has been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to the
sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant will be present and at
which the director will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by,
the field or compliance office personnel unless such field or
compliance office personnel demonstrate to the reviewing
division why such decision should be modified.
(F) No action by the reviewing division may be delayed
because of the unavailability of information from or action by
field personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe and
effective drug.
(G) For purposes of this paragraph, the reviewing division is
the division responsible for the review of an application for
approval of a drug under this subsection (including scientific
matters, chemistry, manufacturing, and controls).
(H)(i) Upon request (in controlled correspondence or an
analogous process) by a person that has submitted or intends to
submit an abbreviated application under this subsection for a
drug that is required by regulation to contain one or more of
the same inactive ingredients in the same concentrations as the
listed drug referred to, or for which the Secretary determines
there is a scientific justification for an approach that is in
vitro, in whole or in part, to be used to demonstrate
bioequivalence for a drug if such a drug contains one or more
of the same inactive ingredients in the same concentrations as
the listed drug referred to, the Secretary shall inform the
person whether such drug is qualitatively and quantitatively
the same as the listed drug. The Secretary may also provide
such information to such a person on the Secretary's own
initiative during the review of an abbreviated application
under this subsection for such drug.
(ii) Notwithstanding section 301(j), if the Secretary
determines that such drug is not qualitatively or
quantitatively the same as the listed drug, the Secretary shall
identify and disclose to the person--
(I) the ingredient or ingredients that cause such
drug not to be qualitatively or quantitatively the same
as the listed drug; and
(II) for any ingredient for which there is an
identified quantitative deviation, the amount of such
deviation.
(iii) If the Secretary determines that such drug is
qualitatively and quantitatively the same as the listed drug,
the Secretary shall not change or rescind such determination
after the submission of an abbreviated application for such
drug under this subsection unless--
(I) the formulation of the listed drug has been
changed and the Secretary has determined that the prior
listed drug formulation was withdrawn for reasons of
safety or effectiveness; or
(II) the Secretary makes a written determination that
the prior determination must be changed because an
error has been identified.
(iv) If the Secretary makes a written determination described
in clause (iii)(II), the Secretary shall provide notice and a
copy of the written determination to the person making the
request under clause (i).
(v) The disclosures authorized under clauses (i) and (ii) are
disclosures authorized by law, including for purposes of
section 1905 of title 18, United States Code. This subparagraph
shall not otherwise be construed to authorize the disclosure of
nonpublic qualitative or quantitative information about the
ingredients in a listed drug, or to affect the status, if any,
of such information as trade secret or confidential commercial
information for purposes of section 301(j) of this Act, section
552 of title 5, United States Code, or section 1905 of title
18, United States Code.
(4) Subject to paragraph (5), the Secretary shall approve an
application for a drug unless the Secretary finds--
(A) the methods used in, or the facilities and
controls used for, the manufacture, processing, and
packing of the drug are inadequate to assure and
preserve its identity, strength, quality, and purity;
(B) information submitted with the application is
insufficient show that each of the proposed conditions
of use have been previously approved for the listed
drug referred to in the application;
(C)(i) if the listed drug has only one active
ingredient, information submitted with the application
is insufficient to show that the active ingredient is
the same as that of the listed drug;
(ii) if the listed drug has more than one active
ingredient, information submitted with the application
is insufficient to show that the active ingredients are
the same as the active ingredients of the listed drug,
or
(iii) if the listed drug has more than one active
ingredient and if the application is for a drug which
has an active ingredient different from the listed
drug, information submitted with the application is
insufficient to show--
(I) that the other active ingredients are the
same as the active ingredients of the listed
drug, or
(II) that the different active ingredient is
an active ingredient of a listed drug or a drug
which does not meet the requirements of section
201(p),
or no petition to file an application for the drug with
the different ingredient was approved under paragraph
(2)(C);
(D)(i) if the application is for a drug whose route
of administration, dosage form, or strength of the drug
is the same as the route of administration, dosage
form, or strength of the listed drug referred to in the
application, information submitted in the application
is insufficient to show that the route of
administration, dosage form, or strength is the same as
that of the listed drug, or
(ii) if the application is for a drug whose route of
administration, dosage form, or strength of the drug is
different from that of the listed drug referred to in
the application, no petition to file an application for
the drug with the different route of administration,
dosage form, or strength was approved under paragraph
(2)(C);
(E) if the application was filed pursuant to the
approval of a petition under paragraph (2)(C), the
application did not contain the information required by
the Secretary respecting the active ingredient, route
of administration, dosage form, or strength which is
not the same;
(F) information submitted in the application is
insufficient to show that the drug is bioequivalent to
the listed drug referred to in the application or, if
the application was filed pursuant to a petition
approved under paragraph (2)(C), information submitted
in the application is insufficient to show that the
active ingredients of the new drug are of the same
pharmacological or therapeutic class as those of the
listed drug referred to in paragraph (2)(A)(i) and that
the new drug can be expected to have the same
therapeutic effect as the listed drug when administered
to patients for a condition of use referred to in such
paragraph;
(G) information submitted in the application is
insufficient to show that the labeling proposed for the
drug is the same as the labeling approved for the
listed drug referred to in the application except for
changes required because of differences approved under
a petition filed under paragraph (2)(C) or because the
drug and the listed drug are produced or distributed by
different manufacturers;
(H) information submitted in the application or any
other information available to the Secretary shows that
(i) the inactive ingredients of the drug are unsafe for
use under the conditions prescribed, recommended, or
suggested in the labeling proposed for the drug, or
(ii) the composition of the drug is unsafe under such
conditions because of the type or quantity of inactive
ingredients included or the manner in which the
inactive ingredients are included;
(I) the approval under subsection (c) of the listed
drug referred to in the application under this
subsection has been withdrawn or suspended for grounds
described in the first sentence of subsection (e), the
Secretary has published a notice of opportunity for
hearing to withdraw approval of the listed drug under
subsection (c) for grounds described in the first
sentence of subsection (e), the approval under this
subsection of the listed drug referred to in the
application under this subsection has been withdrawn or
suspended under paragraph (6), or the Secretary has
determined that the listed drug has been withdrawn from
sale for safety or effectiveness reasons;
(J) the application does not meet any other
requirement of paragraph (2)(A); or
(K) the application contains an untrue statement of
material fact.
(5)(A) Within one hundred and eighty days of the initial
receipt of an application under paragraph (2) or within such
additional period as may be agreed upon by the Secretary and
the applicant, the Secretary shall approve or disapprove the
application.
(B) The approval of an application submitted under paragraph
(2) shall be made effective on the last applicable date
determined by applying the following to each certification made
under paragraph (2)(A)(vii):
(i) If the applicant only made a certification
described in subclause (I) or (II) of paragraph
(2)(A)(vii) or in both such subclauses, the approval
may be made effective immediately.
(ii) If the applicant made a certification described
in subclause (III) of paragraph (2)(A)(vii), the
approval may be made effective on the date certified
under subclause (III).
(iii) If the applicant made a certification described
in subclause (IV) of paragraph (2)(A)(vii), the
approval shall be made effective immediately unless,
before the expiration of 45 days after the date on
which the notice described in paragraph (2)(B) is
received, an action is brought for infringement of the
patent that is the subject of the certification and for
which information was submitted to the Secretary under
subsection (b)(1) or (c)(2) before the date on which
the application (excluding an amendment or supplement
to the application), which the Secretary later
determines to be substantially complete, was submitted.
If such an action is brought before the expiration of
such days, the approval shall be made effective upon
the expiration of the thirty-month period beginning on
the date of the receipt of the notice provided under
paragraph (2)(B)(i) or such shorter or longer period as
the court may order because either party to the action
failed to reasonably cooperate in expediting the
action, except that--
(I) if before the expiration of such period
the district court decides that the patent is
invalid or not infringed (including any
substantive determination that there is no
cause of action for patent infringement or
invalidity), the approval shall be made
effective on--
(aa) the date on which the court
enters judgment reflecting the
decision; or
(bb) the date of a settlement order
or consent decree signed and entered by
the court stating that the patent that
is the subject of the certification is
invalid or not infringed;
(II) if before the expiration of such period
the district court decides that the patent has
been infringed--
(aa) if the judgment of the district
court is appealed, the approval shall
be made effective on--
(AA) the date on which the
court of appeals decides that
the patent is invalid or not
infringed (including any
substantive determination that
there is no cause of action for
patent infringement or
invalidity); or
(BB) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the patent
that is the subject of the
certification is invalid or not
infringed; or
(bb) if the judgment of the district
court is not appealed or is affirmed,
the approval shall be made effective on
the date specified by the district
court in a court order under section
271(e)(4)(A) of title 35, United States
Code;
(III) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent is invalid or not
infringed, the approval shall be made effective
as provided in subclause (I); or
(IV) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent has been infringed,
the approval shall be made effective as
provided in subclause (II).
In such an action, each of the parties shall reasonably
cooperate in expediting the action.
(iv) 180-day exclusivity period.--
(I) Effectiveness of application.--Subject to
subparagraph (D), if the application contains a
certification described in paragraph
(2)(A)(vii)(IV) and is for a drug for which a
first applicant has submitted an application
containing such a certification, the
application shall be made effective on the date
that is 180 days after the date of the first
commercial marketing of the drug (including the
commercial marketing of the listed drug) by any
first applicant.
(II) Definitions.--In this paragraph:
(aa) 180-day exclusivity period.--
The term ``180-day exclusivity period''
means the 180-day period ending on the
day before the date on which an
application submitted by an applicant
other than a first applicant could
become effective under this clause.
(bb) First applicant.--As used in
this subsection, the term ``first
applicant'' means an applicant that, on
the first day on which a substantially
complete application containing a
certification described in paragraph
(2)(A)(vii)(IV) is submitted for
approval of a drug, submits a
substantially complete application that
contains and lawfully maintains a
certification described in paragraph
(2)(A)(vii)(IV) for the drug.
(cc) Substantially complete
application.--As used in this
subsection, the term ``substantially
complete application'' means an
application under this subsection that
on its face is sufficiently complete to
permit a substantive review and
contains all the information required
by paragraph (2)(A).
(dd) Tentative approval.--
(AA) In general.--The term
``tentative approval'' means
notification to an applicant by
the Secretary that an
application under this
subsection meets the
requirements of paragraph
(2)(A), but cannot receive
effective approval because the
application does not meet the
requirements of this
subparagraph, there is a period
of exclusivity for the listed
drug under subparagraph (F) or
section 505A, or there is a 7-
year period of exclusivity for
the listed drug under section
527.
(BB) Limitation.--A drug that
is granted tentative approval
by the Secretary is not an
approved drug and shall not
have an effective approval
until the Secretary issues an
approval after any necessary
additional review of the
application.
(v) 180-day exclusivity period for competitive
generic therapies.--
(I) Effectiveness of application.--Subject to
subparagraph (D)(iv), if the application is for
a drug that is the same as a competitive
generic therapy for which any first approved
applicant has commenced commercial marketing,
the application shall be made effective on the
date that is 180 days after the date of the
first commercial marketing of the competitive
generic therapy (including the commercial
marketing of the listed drug) by any first
approved applicant.
(II) Limitation.--The exclusivity period
under subclause (I) shall not apply with
respect to a competitive generic therapy that
has previously received an exclusivity period
under subclause (I).
(III) Definitions.--In this clause and
subparagraph (D)(iv):
(aa) The term ``competitive generic
therapy'' means a drug--
(AA) that is designated as a
competitive generic therapy
under section 506H; and
(BB) for which there are no
unexpired patents or
exclusivities on the list of
products described in section
505(j)(7)(A) at the time of
submission.
(bb) The term ``first approved
applicant'' means any applicant that
has submitted an application that--
(AA) is for a competitive
generic therapy that is
approved on the first day on
which any application for such
competitive generic therapy is
approved;
(BB) is not eligible for a
180-day exclusivity period
under clause (iv) for the drug
that is the subject of the
application for the competitive
generic therapy; and
(CC) is not for a drug for
which all drug versions have
forfeited eligibility for a
180-day exclusivity period
under clause (iv) pursuant to
subparagraph (D).
(C) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement
action.--
(I) In general.--No action may be
brought under section 2201 of title 28,
United States Code, by an applicant
under paragraph (2) for a declaratory
judgment with respect to a patent which
is the subject of the certification
referred to in subparagraph (B)(iii)
unless--
(aa) the 45-day period
referred to in such
subparagraph has expired;
(bb) neither the owner of
such patent nor the holder of
the approved application under
subsection (b) for the drug
that is claimed by the patent
or a use of which is claimed by
the patent brought a civil
action against the applicant
for infringement of the patent
before the expiration of such
period; and
(cc) in any case in which the
notice provided under paragraph
(2)(B) relates to
noninfringement, the notice was
accompanied by a document
described in subclause (III).
(II) Filing of civil action.--If the
conditions described in items (aa),
(bb), and as applicable, (cc) of
subclause (I) have been met, the
applicant referred to in such subclause
may, in accordance with section 2201 of
title 28, United States Code, bring a
civil action under such section against
the owner or holder referred to in such
subclause (but not against any owner or
holder that has brought such a civil
action against the applicant, unless
that civil action was dismissed without
prejudice) for a declaratory judgment
that the patent is invalid or will not
be infringed by the drug for which the
applicant seeks approval, except that
such civil action may be brought for a
declaratory judgment that the patent
will not be infringed only in a case in
which the condition described in
subclause (I)(cc) is applicable. A
civil action referred to in this
subclause shall be brought in the
judicial district where the defendant
has its principal place of business or
a regular and established place of
business.
(III) Offer of confidential access to
application.--For purposes of subclause
(I)(cc), the document described in this
subclause is a document providing an
offer of confidential access to the
application that is in the custody of
the applicant under paragraph (2) for
the purpose of determining whether an
action referred to in subparagraph
(B)(iii) should be brought. The
document providing the offer of
confidential access shall contain such
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, as would
apply had a protective order been
entered for the purpose of protecting
trade secrets and other confidential
business information. A request for
access to an application under an offer
of confidential access shall be
considered acceptance of the offer of
confidential access with the
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, contained
in the offer of confidential access,
and those restrictions and other terms
of the offer of confidential access
shall be considered terms of an
enforceable contract. Any person
provided an offer of confidential
access shall review the application for
the sole and limited purpose of
evaluating possible infringement of the
patent that is the subject of the
certification under paragraph
(2)(A)(vii)(IV) and for no other
purpose, and may not disclose
information of no relevance to any
issue of patent infringement to any
person other than a person provided an
offer of confidential access. Further,
the application may be redacted by the
applicant to remove any information of
no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the
patent or the holder of the approved
application under subsection (b) for
the drug that is claimed by the patent
or a use of which is claimed by the
patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the holder
to correct or delete the patent
information submitted by the holder
under subsection (b) or (c) on the
ground that the patent does not claim
either--
(aa) the drug for which the
application was approved; or
(bb) an approved method of
using the drug.
(II) No independent cause of
action.--Subclause (I) does not
authorize the assertion of a claim
described in subclause (I) in any civil
action or proceeding other than a
counterclaim described in subclause
(I).
(iii) No damages.--An applicant shall not be
entitled to damages in a civil action under
clause (i) or a counterclaim under clause (ii).
(D) Forfeiture of 180-day exclusivity period.--
(i) Definition of forfeiture event.--In this
subparagraph, the term ``forfeiture event'',
with respect to an application under this
subsection, means the occurrence of any of the
following:
(I) Failure to market.--The first
applicant fails to market the drug by
the later of--
(aa) the earlier of the date
that is--
(AA) 75 days after
the date on which the
approval of the
application of the
first applicant is made
effective under
subparagraph (B)(iii);
or
(BB) 30 months after
the date of submission
of the application of
the first applicant; or
(bb) with respect to the
first applicant or any other
applicant (which other
applicant has received
tentative approval), the date
that is 75 days after the date
as of which, as to each of the
patents with respect to which
the first applicant submitted
and lawfully maintained a
certification qualifying the
first applicant for the 180-day
exclusivity period under
subparagraph (B)(iv), at least
1 of the following has
occurred:
(AA) In an
infringement action
brought against that
applicant with respect
to the patent or in a
declaratory judgment
action brought by that
applicant with respect
to the patent, a court
enters a final decision
from which no appeal
(other than a petition
to the Supreme Court
for a writ of
certiorari) has been or
can be taken that the
patent is invalid or
not infringed.
(BB) In an
infringement action or
a declaratory judgment
action described in
subitem (AA), a court
signs a settlement
order or consent decree
that enters a final
judgment that includes
a finding that the
patent is invalid or
not infringed.
(CC) The patent
information submitted
under subsection (b) or
(c) is withdrawn by the
holder of the
application approved
under subsection (b).
(II) Withdrawal of application.--The
first applicant withdraws the
application or the Secretary considers
the application to have been withdrawn
as a result of a determination by the
Secretary that the application does not
meet the requirements for approval
under paragraph (4).
(III) Amendment of certification.--
The first applicant amends or withdraws
the certification for all of the
patents with respect to which that
applicant submitted a certification
qualifying the applicant for the 180-
day exclusivity period.
(IV) Failure to obtain tentative
approval.--The first applicant fails to
obtain tentative approval of the
application within 30 months after the
date on which the application is filed,
unless the failure is caused by a
change in or a review of the
requirements for approval of the
application imposed after the date on
which the application is filed.
(V) Agreement with another applicant,
the listed drug application holder, or
a patent owner.--The first applicant
enters into an agreement with another
applicant under this subsection for the
drug, the holder of the application for
the listed drug, or an owner of the
patent that is the subject of the
certification under paragraph
(2)(A)(vii)(IV), the Federal Trade
Commission or the Attorney General
files a complaint, and there is a final
decision of the Federal Trade
Commission or the court with regard to
the complaint from which no appeal
(other than a petition to the Supreme
Court for a writ of certiorari) has
been or can be taken that the agreement
has violated the antitrust laws (as
defined in section 1 of the Clayton Act
(15 U.S.C. 12), except that the term
includes section 5 of the Federal Trade
Commission Act (15 U.S.C. 45) to the
extent that that section applies to
unfair methods of competition).
(VI) Expiration of all patents.--All
of the patents as to which the
applicant submitted a certification
qualifying it for the 180-day
exclusivity period have expired.
(ii) Forfeiture.--The 180-day exclusivity
period described in subparagraph (B)(iv) shall
be forfeited by a first applicant if a
forfeiture event occurs with respect to that
first applicant.
(iii) Subsequent applicant.--If all first
applicants forfeit the 180-day exclusivity
period under clause (ii)--
(I) approval of any application
containing a certification described in
paragraph (2)(A)(vii)(IV) shall be made
effective in accordance with
subparagraph (B)(iii); and
(II) no applicant shall be eligible
for a 180-day exclusivity period.
(iv) Special forfeiture rule for competitive
generic therapy.--The 180-day exclusivity
period described in subparagraph (B)(v) shall
be forfeited by a first approved applicant if
the applicant fails to market the competitive
generic therapy within 75 days after the date
on which the approval of the first approved
applicant's application for the competitive
generic therapy is made effective.
(E) If the Secretary decides to disapprove an application,
the Secretary shall give the applicant notice of an opportunity
for a hearing before the Secretary on the question of whether
such application is approvable. If the applicant elects to
accept the opportunity for hearing by written request within
thirty days after such notice, such hearing shall commence not
more than ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree. Any
such hearing shall thereafter be conducted on an expedited
basis and the Secretary's order thereon shall be issued within
ninety days after the date fixed by the Secretary for filing
final briefs.
(F)
(ii) If an application submitted under subsection (b) for a
drug, no active moiety (as defined by the Secretary in section
314.3 of title 21, Code of Federal Regulations (or any
successor regulations)) of which has been approved in any other
application under subsection (b), is approved after the date of
the enactment of this subsection, no application may be
submitted under this subsection which refers to the drug for
which the subsection (b) application was submitted before the
expiration of five years from the date of the approval of the
application under subsection (b), except that such an
application may be submitted under this subsection after the
expiration of four years from the date of the approval of the
subsection (b) application if it contains a certification of
patent invalidity or noninfringement described in subclause
(IV) of paragraph (2)(A)(vii). The approval of such an
application shall be made effective in accordance with
subparagraph (B) except that, if an action for patent
infringement is commenced during the one-year period beginning
forty-eight months after the date of the approval of the
subsection (b) application, the thirty-month period referred to
in subparagraph (B)(iii) shall be extended by such amount of
time (if any) which is required for seven and one-half years to
have elapsed from the date of approval of the subsection (b)
application.
(iii) If an application submitted under subsection (b) for a
drug, which includes an active moiety (as defined by the
Secretary in section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations)) that has been
approved in another application approved under subsection (b),
is approved after the date of enactment of this subsection and
if such application contains reports of new clinical
investigations (other than bioavailability studies) essential
to the approval of the application and conducted or sponsored
by the applicant, the Secretary may not make the approval of an
application submitted under this subsection for the conditions
of approval of such drug in the subsection (b) application
effective before the expiration of three years from the date of
the approval of the application under subsection (b) for such
drug.
(iv) If a supplement to an application approved under
subsection (b) is approved after the date of enactment of this
subsection and the supplement contains reports of new clinical
investigations (other than bioavailability studies) essential
to the approval of the supplement and conducted or sponsored by
the person submitting the supplement, the Secretary may not
make the approval of an application submitted under this
subsection for a change approved in the supplement effective
before the expiration of three years from the date of the
approval of the supplement under subsection (b).
(v) If an application (or supplement to an application)
submitted under subsection (b) for a drug, which includes an
active moiety (as defined by the Secretary in section 314.3 of
title 21, Code of Federal Regulations (or any successor
regulations)) that has been approved in another application
under subsection (b), was approved during the period beginning
January 1, 1982, and ending on the date of the enactment of
this subsection, the Secretary may not make the approval of an
application submitted under this subsection which refers to the
drug for which the subsection (b) application was submitted or
which refers to a change approved in a supplement to the
subsection (b) application effective before the expiration of
two years from the date of enactment of this subsection.
(6) If a drug approved under this subsection refers in its
approved application to a drug the approval of which was
withdrawn or suspended for grounds described in the first
sentence of subsection (e) or was withdrawn or suspended under
this paragraph or which, as determined by the Secretary, has
been withdrawn from sale for safety or effectiveness reasons,
the approval of the drug under this subsection shall be
withdrawn or suspended--
(A) for the same period as the withdrawal or
suspension under subsection (e) or this paragraph, or
(B) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
(7)(A)(i) Within sixty days of the date of the enactment of
this subsection, the Secretary shall publish and make available
to the public--
(I) a list in alphabetical order of the official and
proprietary name of each drug which has been approved
for safety and effectiveness under subsection (c)
before the date of the enactment of this subsection;
(II) the date of approval if the drug is approved
after 1981 and the number of the application which was
approved; and
(III) whether in vitro or in vivo bioequivalence
studies, or both such studies, are required for
applications filed under this subsection which will
refer to the drug published.
(ii) Every thirty days after the publication of the first
list under clause (i) the Secretary shall revise the list to
include each drug which has been approved for safety and
effectiveness under subsection (c) or approved under this
subsection during the thirty-day period.
(iii) When patent information submitted under subsection (c)
respecting a drug included on the list is to be published by
the Secretary, the Secretary shall, in revisions made under
clause (ii), include such information for such drug.
(iv) For each drug included on the list, the Secretary shall
specify any exclusivity period that is applicable, for which
the Secretary has determined the expiration date, and for which
such period has not yet expired, under--
(I) clause (ii), (iii), or (iv) of subsection
(c)(3)(E);
(II) clause (iv) or (v) of paragraph (5)(B);
(III) clause (ii), (iii), or (iv) of paragraph
(5)(F);
(IV) section 505A;
(V) section 505E;
(VI) section 527(a); or
(VII) subsection (u).
(v)(I) With respect to an application submitted pursuant to
subsection (b)(2) for a drug that is subject to section 503(b)
for which the sole difference from a listed drug relied upon in
the application is a difference in inactive ingredients not
permitted under clause (iii) or (iv) of section 314.94(a)(9) of
title 21, Code of Federal Regulations (or any successor
regulations), the Secretary shall make an evaluation with
respect to whether such drug is a therapeutic equivalent (as
defined in section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations)) to another approved
drug product in the prescription drug product section of the
list under this paragraph as follows:
(aa) With respect to such an application submitted
after the date of enactment of the Food and Drug
Omnibus Reform Act of 2022, the evaluation shall be
made with respect to a listed drug relied upon in the
application pursuant to subsection (b)(2) that is a
pharmaceutical equivalent (as defined in section 314.3
of title 21, Code of Federal Regulations (or any
successor regulations)) to the drug in the application
pursuant to subsection (b)(2) at the time of approval
of such application or not later than 180 days after
the date of such approval, provided that the request
for such an evaluation is made in the original
application (or in a resubmission to a complete
response letter), and all necessary data and
information are submitted in the original application
(or in a resubmission in response to a complete
response letter) for the therapeutic equivalence
evaluation, including information to demonstrate
bioequivalence, in a form and manner prescribed by the
Secretary.
(bb) With respect to such an application approved
prior to or on the date of enactment of the Food and
Drug Omnibus Reform Act of 2022, the evaluation shall
be made not later than 180 days after receipt of a
request for a therapeutic equivalence evaluation
submitted as part of a supplement to such application;
or with respect to an application that was submitted
prior to the date of enactment of the Food and Drug
Omnibus Reform Act of 2022 but not approved as of the
date of enactment of such Act, the evaluation shall be
made not later than 180 days after the date of approval
of such application if a request for such evaluation is
submitted as an amendment to the application, provided
that--
(AA) such request for a therapeutic
equivalence evaluation is being sought with
respect to a listed drug relied upon in the
application, and the relied upon listed drug is
in the prescription drug product section of the
list under this paragraph and is a
pharmaceutical equivalent (as defined in
section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations)) to
the drug for which a therapeutic equivalence
evaluation is sought; and
(BB) the amendment or supplement, as
applicable, containing such request, or the
relevant application, includes all necessary
data and information for the therapeutic
equivalence evaluation, including information
to demonstrate bioequivalence, in a form and
manner prescribed by the Secretary.
(II) When the Secretary makes an evaluation under subclause
(I), the Secretary shall, in revisions made to the list
pursuant to clause (ii), include such information for such
drug.
(B) A drug approved for safety and effectiveness under
subsection (c) or approved under this subsection shall, for
purposes of this subsection, be considered to have been
published under subparagraph (A) on the date of its approval or
the date of enactment, whichever is later.
(C) If the approval of a drug was withdrawn or suspended for
grounds described in the first sentence of subsection (e) or
was withdrawn or suspended under paragraph (6) or if the
Secretary determines that a drug has been withdrawn from sale
for safety or effectiveness reasons, it may not be published in
the list under subparagraph (A) or, if the withdrawal or
suspension occurred after its publication in such list, it
shall be immediately removed from such list--
(i) for the same period as the withdrawal or
suspension under subsection (e) or paragraph (6), or
(ii) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
A notice of the removal shall be published in the Federal
Register.
(D) In the case of a listed drug for which the list under
subparagraph (A)(i) includes a patent for such drug, and any
claim of the patent has been cancelled or invalidated pursuant
to a final decision issued by the Patent Trial and Appeal Board
of the United States Patent and Trademark Office or by a court,
from which no appeal has been, or can be, taken, if the holder
of the applicable application approved under subsection (c)
determines that a patent for such drug, or any patent
information for such drug, no longer meets the listing
requirements under this section--
(i) the holder of such approved application shall
notify the Secretary, in writing, within 14 days of
such decision of such cancellation or invalidation and
request that such patent or patent information, as
applicable, be amended or withdrawn in accordance with
the decision issued by the Patent Trial and Appeal
Board or a court;
(ii) the holder of such approved application shall
include in any notification under clause (i)
information related to such patent cancellation or
invalidation decision and submit such information,
including a copy of such decision, to the Secretary;
and
(iii) the Secretary shall, in response to a
notification under clause (i), amend or remove patent
or patent information in accordance with the relevant
decision from the Patent Trial and Appeals Board or
court, as applicable, except that the Secretary shall
not remove from the list any patent or patent
information before the expiration of any 180-day
exclusivity period under paragraph (5)(B)(iv) that
relies on a certification described in paragraph
(2)(A)(vii)(IV).
(8) For purposes of this subsection:
(A)(i) The term ``bioavailability'' means the rate
and extent to which the active ingredient or
therapeutic ingredient is absorbed from a drug and
becomes available at the site of drug action.
(ii) For a drug that is not intended to be absorbed
into the bloodstream, the Secretary may assess
bioavailability by scientifically valid measurements
intended to reflect the rate and extent to which the
active ingredient or therapeutic ingredient becomes
available at the site of drug action.
(B) A drug shall be considered to be bioequivalent to
a listed drug if--
(i) the rate and extent of absorption of the
drug do not show a significant difference from
the rate and extent of absorption of the listed
drug when administered at the same molar dose
of the therapeutic ingredient under similar
experimental conditions in either a single dose
or multiple doses; or
(ii) the extent of absorption of the drug
does not show a significant difference from the
extent of absorption of the listed drug when
administered at the same molar dose of the
therapeutic ingredient under similar
experimental conditions in either a single dose
or multiple doses and the difference from the
listed drug in the rate of absorption of the
drug is intentional, is reflected in its
proposed labeling, is not essential to the
attainment of effective body drug
concentrations on chronic use, and is
considered medically insignificant for the
drug.
(C) For a drug that is not intended to be absorbed
into the bloodstream, the Secretary may establish
alternative, scientifically valid methods to show
bioequivalence if the alternative methods are expected
to detect a significant difference between the drug and
the listed drug in safety and therapeutic effect.
(9) The Secretary shall, with respect to each application
submitted under this subsection, maintain a record of--
(A) the name of the applicant,
(B) the name of the drug covered by the application,
(C) the name of each person to whom the review of the
chemistry of the application was assigned and the date
of such assignment, and
(D) the name of each person to whom the
bioequivalence review for such application was assigned
and the date of such assignment.
The information the Secretary is required to maintain under
this paragraph with respect to an application submitted under
this subsection shall be made available to the public after the
approval of such application.
(10)(A) If the proposed labeling of a drug that is the
subject of an application under this subsection differs from
the listed drug due to a labeling revision described under
clause (i), the drug that is the subject of such application
shall, notwithstanding any other provision of this Act, be
eligible for approval and shall not be considered misbranded
under section 502 if--
(i) a revision to the labeling of the listed drug has
been approved by the Secretary within 90 days of when
the application is otherwise eligible for approval
under this subsection;
(ii) the sponsor of the application agrees to submit
revised labeling for the drug that is the subject of
the application not later than 60 days after approval
under this subsection of the application;
(iii) the labeling revision described under clause
(i) does not include a change to the ``Warnings''
section of the labeling; and
(iv) such application otherwise meets the applicable
requirements for approval under this subsection.
(B) If, after a labeling revision described in subparagraph
(A)(i), the Secretary determines that the continued presence in
interstate commerce of the labeling of the listed drug (as in
effect before the revision described in subparagraph (A)(i))
adversely impacts the safe use of the drug, no application
under this subsection shall be eligible for approval with such
labeling.
(11)(A) Subject to subparagraph (B), the Secretary shall
prioritize the review of, and act within 8 months of the date
of the submission of, an original abbreviated new drug
application submitted for review under this subsection that is
for a drug--
(i) for which there are not more than 3 approved drug
products listed under paragraph (7) and for which there
are no blocking patents and exclusivities; or
(ii) that has been included on the list under section
506E.
(B) To qualify for priority review under this paragraph, not
later than 60 days prior to the submission of an application
described in subparagraph (A) or that the Secretary may
prioritize pursuant to subparagraph (D), the applicant shall
provide complete, accurate information regarding facilities
involved in manufacturing processes and testing of the drug
that is the subject of the application, including facilities in
corresponding Type II active pharmaceutical ingredients drug
master files referenced in an application and sites or
organizations involved in bioequivalence and clinical studies
used to support the application, to enable the Secretary to
make a determination regarding whether an inspection of a
facility is necessary. Such information shall include the
relevant (as determined by the Secretary) sections of such
application, which shall be unchanged relative to the date of
the submission of such application, except to the extent that a
change is made to such information to exclude a facility that
was not used to generate data to meet any application
requirements for such submission and that is not the only
facility intended to conduct one or more unit operations in
commercial production. Information provided by an applicant
under this subparagraph shall not be considered the submission
of an application under this subsection.
(C) The Secretary may expedite an inspection or reinspection
under section 704 of an establishment that proposes to
manufacture a drug described in subparagraph (A).
(D) Nothing in this paragraph shall prevent the Secretary
from prioritizing the review of other applications as the
Secretary determines appropriate.
(12) The Secretary shall publish on the internet website of
the Food and Drug Administration, and update at least once
every 6 months, a list of all drugs approved under subsection
(c) for which all patents and periods of exclusivity under this
Act have expired and for which no application has been approved
under this subsection.
(13) Upon the request of an applicant regarding one or more
specified pending applications under this subsection, the
Secretary shall, as appropriate, provide review status updates
indicating the categorical status of the applications by each
relevant review discipline.
(k)(1) In the case of any drug for which an approval of an
application filed under subsection (b) or (j) is in effect, the
applicant shall establish and maintain such records, and make
such reports to the Secretary, of data relating to clinical
experience and other data or information, received or otherwise
obtained by such applicant with respect to such drug, as the
Secretary may by general regulation, or by order with respect
to such application, prescribe on the basis of a finding that
such records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination, whether
there is or may be ground for invoking subsection (e) of this
section. Regulations and orders issued under this subsection
and under subsection (i) shall have due regard for the
professional ethics of the medical profession and the interests
of patients and shall provide, where the Secretary deems it to
be appropriate, for the examination, upon request, by the
persons to whom such regulations or orders are applicable, of
similar information received or otherwise obtained by the
Secretary.
(2) Every person required under this section to maintain
records, and every person in charge or custody thereof, shall,
upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable
times to have access to and copy and verify such records.
(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.
(5) The Secretary shall--
(A) conduct regular screenings 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; and
(B) 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; and
(C) make available on the Internet website of the
Food and Drug Administration--
(i) guidelines, developed with input from
experts qualified by scientific training and
experience to evaluate the safety and
effectiveness of drugs, that detail best
practices for drug safety surveillance using
the Adverse Event Reporting System; and
(ii) criteria for public posting of adverse
event signals.
(l)(1) Safety and effectiveness data and information which
has been submitted in an application under subsection (b) for a
drug and which has not previously been disclosed to the public
shall be made available to the public, upon request, unless
extraordinary circumstances are shown--
(A) if no work is being or will be undertaken to have
the application approved,
(B) if the Secretary has determined that the
application is not approvable and all legal appeals
have been exhausted,
(C) if approval of the application under subsection
(c) is withdrawn and all legal appeals have been
exhausted,
(D) if the Secretary has determined that such drug is
not a new drug, or
(E) upon the effective date of the approval of the
first application under subsection (j) which refers to
such drug or upon the date upon which the approval of
an application under subsection (j) which refers to
such drug could be made effective if such an
application had been submitted.
(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 applications--
(I) for a drug, no active moiety (as
defined by the Secretary in section
314.3 of title 21, Code of Federal
Regulations (or any successor
regulations)) of which has been
approved in any other application under
this section; or
(II) for a biological product, no
active ingredient of which has been
approved in any other application under
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 or biological
product.
(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.
(m) For purposes of this section, the term ``patent'' means a
patent issued by the United States Patent and Trademark Office.
(n)(1) For the purpose of providing expert scientific advice
and recommendations to the Secretary regarding a clinical
investigation of a drug or the approval for marketing of a drug
under section 505 or section 351 of the Public Health Service
Act, the Secretary shall establish panels of experts or use
panels of experts established before the date of enactment of
the Food and Drug Administration Modernization Act of 1997, or
both.
(2) The Secretary may delegate the appointment and oversight
authority granted under section 1004 to a director of a center
or successor entity within the Food and Drug Administration.
(3) The Secretary shall make appointments to each panel
established under paragraph (1) so that each panel shall
consist of--
(A) members who are qualified by training and
experience to evaluate the safety and effectiveness of
the drugs to be referred to the panel and who, to the
extent feasible, possess skill and experience in the
development, manufacture, or utilization of such drugs;
(B) members with diverse expertise in such fields as
clinical and administrative medicine, pharmacy,
pharmacology, pharmacoeconomics, biological and
physical sciences, and other related professions;
(C) a representative of consumer interests, and a
representative of interests of the drug manufacturing
industry not directly affected by the matter to be
brought before the panel; and
(D) two or more members who are specialists or have
other expertise in the particular disease or condition
for which the drug under review is proposed to be
indicated.
Scientific, trade, and consumer organizations shall be afforded
an opportunity to nominate individuals for appointment to the
panels. No individual who is in the regular full-time employ of
the United States and engaged in the administration of this Act
may be a voting member of any panel. The Secretary shall
designate one of the members of each panel to serve as chairman
thereof.
(4) The Secretary shall, as appropriate, provide education
and training to each new panel member before such member
participates in a panel's activities, including education
regarding requirements under this Act and related regulations
of the Secretary, and the administrative processes and
procedures related to panel meetings.
(5) Panel members (other than officers or employees of the
United States), while attending meetings or conferences of a
panel or otherwise engaged in its business, shall be entitled
to receive compensation for each day so engaged, including
traveltime, at rates to be fixed by the Secretary, but not to
exceed the daily equivalent of the rate in effect for positions
classified above grade GS-15 of the General Schedule. While
serving away from their homes or regular places of business,
panel members may be allowed travel expenses (including per
diem in lieu of subsistence) as authorized by section 5703 of
title 5, United States Code, for persons in the Government
service employed intermittently.
(6) The Secretary shall ensure that scientific advisory
panels meet regularly and at appropriate intervals so that any
matter to be reviewed by such a panel can be presented to the
panel not more than 60 days after the matter is ready for such
review. Meetings of the panel may be held using electronic
communication to convene the meetings.
(7) Within 90 days after a scientific advisory panel makes
recommendations on any matter under its review, the Food and
Drug Administration official responsible for the matter shall
review the conclusions and recommendations of the panel, and
notify the affected persons of the final decision on the
matter, or of the reasons that no such decision has been
reached. Each such final decision shall be documented including
the rationale for the decision.
(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 or new effectiveness
information.--If the Secretary becomes aware of
new information, including any new safety
information or information related to reduced
effectiveness, that the Secretary determines
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
new effectiveness information; 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 or new effectiveness
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 or
new effectiveness 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).
(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) of
this section or section 351(k) of the Public
Health Service Act 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.
Consideration of the petition shall be separate
and apart from review and approval of any
application.
(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 150 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 150 days.--The
Secretary shall be considered to have taken
final agency action on a petition if--
(i) during the 150-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.--
(A) This subsection does not apply to--
(i) a petition that relates solely to
the timing of the approval of an
application pursuant to subsection
(j)(5)(B)(iv); or
(ii) 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.
(B) Paragraph (2) does not apply to a
petition addressing issues concerning an
application submitted pursuant to section
351(k) of the Public Health Service Act.
(5) Definitions.--
(A) Application.--For purposes of this
subsection, the term ``application'' means an
application submitted under subsection (b)(2)
or (j) of this section or section 351(k) of the
Public Health Service Act.
(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).
(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 and making publicly available
on the Internet website established under
paragraph (1) best practices for drug safety
surveillance activities for drugs approved
under this section or section 351 of the Public
Health Service Act;
(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.
(s) Referral to Advisory Committee.--The Secretary shall--
(1) refer a drug or biological product to a Food and
Drug Administration advisory committee for review at a
meeting of such advisory committee prior to the
approval of such drug or biological if it is--
(A) a drug, no active moiety (as defined by
the Secretary in section 314.3 of title 21,
Code of Federal Regulations (or any successor
regulations)) of which has been approved in any
other application under this section; or
(B) a biological product, no active
ingredient of which has been approved in any
other application under section 351 of the
Public Health Service Act; or
(2) if the Secretary does not refer a drug or
biological product described in paragraph (1) to a Food
and Drug Administration advisory committee prior to
such approval, provide in the action letter on the
application for the drug or biological product a
summary of the reasons why the Secretary did not refer
the drug or biological product to an advisory committee
prior to approval.
(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.
(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 moiety (as defined by the
Secretary in section 314.3 of title 21, Code of Federal
Regulations (or any successor regulations)) 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 moiety 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 clinical
investigations (other than
bioavailability studies) 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,
2027.
(v) Antibiotic Drugs Submitted Before November 21, 1997.--
(1) Antibiotic drugs approved before november 21,
1997.--
(A) In general.--Notwithstanding any
provision of the Food and Drug Administration
Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is
the subject of an application described in
subparagraph (B)(i) shall be eligible for, with
respect to the drug, the 3-year exclusivity
period referred to under clauses (iii) and (iv)
of subsection (c)(3)(E) and under clauses (iii)
and (iv) of subsection (j)(5)(F), subject to
the requirements of such clauses, as
applicable.
(B) Application; antibiotic drug described.--
(i) Application.--An application
described in this clause is an
application for marketing submitted
under this section after the date of
the enactment of this subsection in
which the drug that is the subject of
the application contains an antibiotic
drug described in clause (ii).
(ii) Antibiotic drug.--An antibiotic
drug described in this clause is an
antibiotic drug that was the subject of
an application approved by the
Secretary under section 507 of this Act
(as in effect before November 21,
1997).
(2) Antibiotic drugs submitted before november 21,
1997, but not approved.--
(A) In general.--Notwithstanding any
provision of the Food and Drug Administration
Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is
the subject of an application described in
subparagraph (B)(i) may elect to be eligible
for, with respect to the drug--
(i)(I) the 3-year exclusivity period
referred to under clauses (iii) and
(iv) of subsection (c)(3)(E) and under
clauses (iii) and (iv) of subsection
(j)(5)(F), subject to the requirements
of such clauses, as applicable; and
(II) the 5-year exclusivity period
referred to under clause (ii) of
subsection (c)(3)(E) and under clause
(ii) of subsection (j)(5)(F), subject
to the requirements of such clauses, as
applicable; or
(ii) a patent term extension under
section 156 of title 35, United States
Code, subject to the requirements of
such section.
(B) Application; antibiotic drug described.--
(i) Application.--An application
described in this clause is an
application for marketing submitted
under this section after the date of
the enactment of this subsection in
which the drug that is the subject of
the application contains an antibiotic
drug described in clause (ii).
(ii) Antibiotic drug.--An antibiotic
drug described in this clause is an
antibiotic drug that was the subject of
1 or more applications received by the
Secretary under section 507 of this Act
(as in effect before November 21,
1997), none of which was approved by
the Secretary under such section.
(3) Limitations.--
(A) Exclusivities and extensions.--Paragraphs
(1)(A) and (2)(A) shall not be construed to
entitle a drug that is the subject of an
approved application described in subparagraphs
(1)(B)(i) or (2)(B)(i), as applicable, to any
market exclusivities or patent extensions other
than those exclusivities or extensions
described in paragraph (1)(A) or (2)(A).
(B) Conditions of use.--Paragraphs (1)(A) and
(2)(A)(i) shall not apply to any condition of
use for which the drug referred to in
subparagraph (1)(B)(i) or (2)(B)(i), as
applicable, was approved before the date of the
enactment of this subsection.
(4) Application of certain provisions.--
Notwithstanding section 125, or any other provision, of
the Food and Drug Administration Modernization Act of
1997, or any other provision of law, and subject to the
limitations in paragraphs (1), (2), and (3), the
provisions of the Drug Price Competition and Patent
Term Restoration Act of 1984 shall apply to any drug
subject to paragraph (1) or any drug with respect to
which an election is made under paragraph (2)(A).
(w) Deadline for Determination on Certain Petitions.--The
Secretary shall issue a final, substantive determination on a
petition submitted pursuant to subsection (b) of section
314.161 of title 21, Code of Federal Regulations (or any
successor regulations), no later than 270 days after the date
the petition is submitted.
(x) Date of Approval in the Case of Recommended Controls
Under the CSA.--
(1) In general.--In the case of an application under
subsection (b) with respect to a drug for which the
Secretary provides notice to the sponsor that the
Secretary intends to issue a scientific and medical
evaluation and recommend controls under the Controlled
Substances Act, approval of such application shall not
take effect until the interim final rule controlling
the drug is issued in accordance with section 201(j) of
the Controlled Substances Act.
(2) Date of approval.--For purposes of this section,
with respect to an application described in paragraph
(1), the term ``date of approval'' shall mean the later
of--
(A) the date an application under subsection
(b) is approved under subsection (c); or
(B) the date of issuance of the interim final
rule controlling the drug.
(y) Contrast Agents Intended for Use With Applicable Medical
Imaging Devices.--
(1) In general.--The sponsor of a contrast agent for
which an application has been approved under this
section may submit a supplement to the application
seeking approval for a new use following the
authorization of a premarket submission for an
applicable medical imaging device for that use with the
contrast agent pursuant to section 520(p)(1).
(2) Review of supplement.--In reviewing a supplement
submitted under this subsection, the agency center
charged with the premarket review of drugs may--
(A) consult with the center charged with the
premarket review of devices; and
(B) review information and data submitted to
the Secretary by the sponsor of an applicable
medical imaging device pursuant to section 515,
510(k), or 513(f)(2) so long as the sponsor of
such applicable medical imaging device has
provided to the sponsor of the contrast agent a
right of reference.
(3) Definitions.--For purposes of this subsection--
(A) the term ``new use'' means a use of a
contrast agent that is described in the
approved labeling of an applicable medical
imaging device described in section 520(p), but
that is not described in the approved labeling
of the contrast agent; and
(B) the terms ``applicable medical imaging
device'' and ``contrast agent'' have the
meanings given such terms in section 520(p).
(z) Nonclinical Test Defined.--For purposes of this section,
the term ``nonclinical test'' means a test conducted in vitro,
in silico, or in chemico, or a nonhuman in vivo test, that
occurs before or during the clinical trial phase of the
investigation of the safety and effectiveness of a drug. Such
test may include the following:
(1) Cell-based assays.
(2) Organ chips and microphysiological systems.
(3) Computer modeling.
(4) Other nonhuman or human biology-based test
methods, such as bioprinting.
(5) Animal tests.
(z)(1) With respect to a clinical investigation of a new drug
that is a phase 3 study, as defined in section 312.21(c) of
title 21, Code of Federal Regulations (or successor
regulations), or, as appropriate, another pivotal study of a
new drug (other than bioavailability or bioequivalence
studies), the sponsor of such drug shall submit to the
Secretary a diversity action plan.
(2) Such diversity action plan shall include--
(A) the sponsor's goals for enrollment in such
clinical study;
(B) the sponsor's rationale for such goals; and
(C) an explanation of how the sponsor intends to meet
such goals.
(3) The sponsor shall submit to the Secretary such diversity
action plan, in the form and manner specified by the Secretary
in guidance, as soon as practicable but not later than the date
on which the sponsor submits the protocol to the Secretary for
such a phase 3 study or other pivotal study of the drug. The
sponsor may submit modifications to the diversity action plan.
Any such modifications shall be in the form and manner
specified by the Secretary in guidance.
(4)(A) On the initiative of the Secretary or at the request
of a sponsor, the Secretary may waive any requirement in
paragraph (1), (2), or (3) if the Secretary determines that a
waiver is necessary based on what is known or what can be
determined about the prevalence or incidence of the disease or
condition for which the new drug is under investigation
(including in terms of the patient population that may use the
drug), if conducting a clinical investigation in accordance
with a diversity action plan would otherwise be impracticable,
or if such waiver is necessary to protect public health during
a public health emergency.
(B) The Secretary shall issue a written response granting or
denying a request from a sponsor for a waiver within 60 days of
receiving such request.
(5) No diversity action plan shall be required for a
submission described in section 561.
* * * * * * *
SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL
PRODUCTS.
(a) New Drugs and Biological Products.--
(1) In general.--
(A) General requirements.--Except with
respect to an application for which
subparagraph (B) applies, 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) for a drug--
(i) under section 505 for a new
active ingredient, new indication, new
dosage form, new dosing regimen, or new
route of administration; or
(ii) 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).
(B) Certain molecularly targeted cancer
indications.--A person that submits, on or
after the date that is 3 years after the date
of enactment of the FDA Reauthorization Act of
2017, an original application for a new active
ingredient under section 505 of this Act or
section 351 of the Public Health Service Act,
shall submit with the application reports on
the investigation described in paragraph (3) if
the drug or biological product that is the
subject of the application is--
(i) intended for the treatment of an
adult cancer; and
(ii) directed at a molecular target
that the Secretary determines to be
substantially relevant to the growth or
progression of a pediatric cancer.
(C) Rule of construction.--No application
that is subject to the requirements of
subparagraph (B) shall be subject to the
requirements of subparagraph (A), and no
application (or supplement to an application)
that is subject to the requirements of
subparagraph (A) shall be subject to the
requirements of subparagraph (B).
(2) Assessments.--
(A) In general.--The assessments referred to
in paragraph (1)(A) 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) Molecularly targeted pediatric cancer
investigation.--
[(A) In general.--With respect to a drug or
biological product described in paragraph
(1)(B), the investigation described in this
paragraph is a molecularly targeted pediatric
cancer investigation, which shall be designed
to yield clinically meaningful pediatric study
data, gathered using appropriate formulations
for each age group for which the study is
required, regarding dosing, safety, and
preliminary efficacy to inform potential
pediatric labeling.]
(A) In general.--For purposes of paragraph
(1)(B), the investigation described in this
paragraph is a molecularly targeted pediatric
cancer investigation of--
(i) the drug or biological product
for which the application referred to
in such paragraph is submitted; or
(ii) such drug or biological product
used in combination with--
(I) an active ingredient of a
drug or biological product--
(aa) for which an
approved application
under section 505(j)
under this Act or under
section 351(k) of the
Public Health Service
Act is in effect; and
(bb) that is
determined by the
Secretary, after
consultation with the
applicant, to be part
of the standard of care
for treating a
pediatric cancer; or
(II) an active ingredient of
a drug or biological product--
(aa) for which an
approved application
under section 505(b) of
this Act or section
351(a) of the Public
Health Service Act to
treat an adult cancer
is in effect and is
held by the same person
submitting the
application under
paragraph (1)(B); and
(bb) that is directed
at a molecular target
that the Secretary
determines to be
substantially relevant
to the growth or
progression of a
pediatric cancer.
(B) Additional requirements.--
(i) Design of investigation.--A
molecularly targeted pediatric cancer
investigation referred to in
subparagraph (A) shall be designed to
yield clinically meaningful pediatric
study data that is gathered using
appropriate formulations for each age
group for which the study is required,
regarding dosing, safety, and
preliminary efficacy to inform
potential pediatric labeling.
(ii) Limitation.--An investigation
described in subparagraph (A)(ii) may
be required only if the drug or
biological product for which the
application referred to in paragraph
(1)(B) contains either--
(I) a single new active
ingredient; or
(II) more than one active
ingredient, if an application
for the combination of active
ingredients has not previously
been approved but each active
ingredient is in a drug product
that has been previously
approved to treat an adult
cancer.
(iii) Results of already-completed
preclinical studies of application
drug.--With respect to an investigation
required pursuant to paragraph (1)(B),
the Secretary may require the results
of any completed preclinical studies
relevant to the initial pediatric study
plan be submitted to the Secretary at
the same time that the initial
pediatric study plan required under
subsection (e)(1) is submitted.
(iv) Rule of construction regarding
inactive ingredients.--With respect to
a combination of active ingredients
referred to in subparagraph (A)(ii),
such subparagraph shall not be
construed as addressing the use of
inactive ingredients with such
combination.
[(B)] (C) Extrapolation of data.--Paragraph
(2)(B) shall apply to [investigations described
in this paragraph] investigations referred to
in subparagraph (A) to the same extent and in
the same manner as paragraph (2)(B) applies
with respect to the assessments required under
paragraph (1)(A).
[(C)] (D) Deferrals and waivers.--Deferrals
and waivers under paragraphs (4) and (5) shall
apply to investigations described in this
paragraph to the same extent and in the same
manner as such deferrals and waivers apply with
respect to [the assessments under paragraph
(2)(B)] the assessments required under
paragraph (1)(A).
(4) 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)(A)
or reports on the investigation required under
paragraph (1)(B) 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 or reports on the
investigation;
(II) a pediatric study plan
as described in subsection (e);
(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) Deferral extension.--
(i) In general.--On the initiative of
the Secretary or at the request of the
applicant, the Secretary may grant an
extension of a deferral approved under
subparagraph (A) for submission of some
or all assessments required under
paragraph (1)(A) or reports on the
investigation required under paragraph
(1)(B) if--
(I) the Secretary determines
that the conditions described
in subclause (II) or (III) of
subparagraph (A)(i) continue to
be met; and
(II) the applicant submits a
new timeline under subparagraph
(A)(ii)(IV) and any significant
updates to the information
required under subparagraph
(A)(ii).
(ii) Timing and information.--If the
deferral extension under this
subparagraph is requested by the
applicant, the applicant shall submit
the deferral extension request
containing the information described in
this subparagraph not less than 90 days
prior to the date that the deferral
would expire. The Secretary shall
respond to such request not later than
45 days after the receipt of such
letter. If the Secretary grants such an
extension, the specified date shall be
the extended date. The sponsor of the
required assessment under paragraph
(1)(A) or reports on the investigation
under paragraph (1)(B) shall not be
issued a letter described in subsection
(d) unless the specified or extended
date of submission for such required
studies has passed or if the request
for an extension is pending. For a
deferral that has expired prior to the
date of enactment of the Food and Drug
Administration Safety and Innovation
Act or that will expire prior to 270
days after the date of enactment of
such Act, a deferral extension shall be
requested by an applicant not later
than 180 days after the date of
enactment of such Act. The Secretary
shall respond to any such request as
soon as practicable, but not later than
1 year after the date of enactment of
such Act. Nothing in this clause shall
prevent the Secretary from updating the
status of a study or studies publicly
if components of such study or studies
are late or delayed.
(C) 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.
(III) Projected completion
date for pediatric studies.
(IV) The reason or reasons
why a deferral or deferral
extension continues to be
necessary.
(ii) Public availability.--Not later
than 90 days after the submission to
the Secretary of the information
submitted through the annual review
under clause (i), the Secretary shall
make available to the public in an
easily accessible manner, including
through the Internet Web site of the
Food and Drug Administration--
(I) such information;
(II) the name of the
applicant for the product
subject to the assessment or
investigation;
(III) the date on which the
product was approved; and
(IV) the date of each
deferral or deferral extension
under this paragraph for the
product.
(5) 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 or reports on the investigation 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 or reports on the investigation 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
partial 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 such a 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.--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 And Reports on the
Investigation.--If a person fails to submit a required
assessment described in subsection (a)(2) or the investigation
described in subsection (a)(3), fails to meet the applicable
requirements in subsection (a)(4), or fails to submit a request
for approval of a pediatric formulation described in subsection
(a) or (b), in accordance with applicable provisions of
subsections (a) and (b), the following shall apply:
(1) [Beginning 270] Noncompliance letter._Beginning
270 days after the date of enactment of the Food and
Drug Administration Safety and Innovation Act, the
Secretary shall issue a non-compliance letter to such
person informing them of such failure to submit or meet
the requirements of the applicable subsection. Such
letter shall require the person to respond in writing
within 45 calendar days of issuance of such letter.
Such response may include the person's request for a
deferral extension if applicable. Such letter and the
person's written response to such letter shall be made
publicly available on the Internet Web site of the Food
and Drug Administration 60 calendar days after
issuance, with redactions for any trade secrets and
confidential commercial information. If the Secretary
determines that the letter was issued in error, the
requirements of this paragraph shall not apply. The
Secretary shall inform the Pediatric Advisory Committee
of letters issued under this paragraph and responses to
such letters.
(2) [The drug or] Effect of noncompliance._The drug
or biological product that is the subject of an
assessment described in subsection (a)(2) or the
investigation described in subsection (a)(3),
applicable requirements in subsection (a)(4), or
request for approval of a pediatric formulation, 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)] (except that the
drug or biological product shall be subject to action
under section 303 only if such person demonstrated a
lack of due diligence in satisfying the applicable
requirement), but such failure 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.
(3) Limitation.--The Secretary shall not issue
enforcement actions under section 303 for failures
under this subsection in the case of a drug or
biological product that is no longer marketed.
(4) Due diligence.--Before the Secretary may conclude
that a person failed to submit or otherwise meet a
requirement as described in the matter preceding
paragraph (1), the Secretary shall--
(A) issue a noncompliance letter pursuant to
paragraph (1);
(B) provide such person with a 45-day period
beginning on the date of receipt of such
noncompliance letter to respond in writing as
set forth in such paragraph; and
(C) after reviewing such written response,
determine whether the person demonstrated a
lack of due diligence in satisfying such
requirement.
(e) Pediatric Study Plans.--
(1) In general.--An applicant subject to subsection
(a) shall submit to the Secretary an initial pediatric
study plan prior to the submission of the assessments
described under subsection (a)(2) or the investigation
described in subsection (a)(3). The Secretary shall
determine whether subparagraph (A) or (B) of subsection
(a)(1) applies with respect to an application before
the date on which the applicant is required to submit
the initial pediatric study plan under paragraph
(2)(A).
(2) Timing; content; meetings.--
(A) Timing.--An applicant shall submit the
initial pediatric study plan under paragraph
(1)--
(i) before the date on which the
applicant submits the assessments under
subsection (a)(2) or the investigation
described in subsection (a)(3); and
(ii) not later than--
(I) 60 calendar days after
the date of the end-of-Phase 2
meeting (as such term is used
in section 312.47 of title 21,
Code of Federal Regulations, or
successor regulations); or
(II) such other time as may
be agreed upon between the
Secretary and the applicant.
Nothing in this section shall preclude the
Secretary from accepting the submission of an
initial pediatric study plan earlier than the
date otherwise applicable under this
subparagraph.
(B) Content of initial pediatric study
plan.--The initial pediatric study plan shall
include--
(i) an outline of the pediatric study
or studies that the applicant plans to
conduct (including, to the extent
practicable study objectives and
design, age groups, relevant endpoints,
and statistical approach);
(ii) any request for a deferral,
partial waiver, or waiver under this
section, if applicable, along with any
supporting information; and
(iii) other information specified in
the regulations promulgated under
paragraph (7).
(C) Meetings.--The Secretary--
(i) shall meet with the applicant--
(I) if requested by the
applicant with respect to a
drug or biological product that
is intended to treat a serious
or life-threatening disease or
condition, to discuss
preparation of the initial
pediatric study plan, not later
than the end-of-Phase 1 meeting
(as such term is used in
section 312.82(b) of title 21,
Code of Federal Regulations, or
successor regulations) or
within 30 calendar days of
receipt of such request,
whichever is later;
(II) to discuss the initial
pediatric study plan as soon as
practicable, but not later than
90 calendar days after the
receipt of such plan under
subparagraph (A); and
(III) to discuss the bases
for the deferral under
subsection (a)(4) or a full or
partial waiver under subsection
(a)(5);
(ii) may determine that a written
response to the initial pediatric study
plan is sufficient to communicate
comments on the initial pediatric study
plan, and that no meeting under clause
(i)(II) is necessary; and
(iii) if the Secretary determines
that no meeting under clause (i)(II) is
necessary, shall so notify the
applicant and provide written comments
of the Secretary as soon as
practicable, but not later than 90
calendar days after the receipt of the
initial pediatric study plan.
(3) Agreed initial pediatric study plan.--Not later
than 90 calendar days following the meeting under
paragraph (2)(C)(i)(II) or the receipt of a written
response from the Secretary under paragraph
(2)(C)(iii), the applicant shall document agreement on
the initial pediatric study plan in a submission to the
Secretary marked ``Agreed Initial Pediatric Study
Plan'', and the Secretary shall confirm such agreement
to the applicant in writing not later than 30 calendar
days of receipt of such agreed initial pediatric study
plan.
(4) Deferral and waiver.--If the agreed initial
pediatric study plan contains a request from the
applicant for a deferral, partial waiver, or waiver
under this section, the written confirmation under
paragraph (3) shall include a recommendation from the
Secretary as to whether such request meets the
standards under paragraphs (3) or (4) of subsection
(a).
(5) Amendments to the agreed initial pediatric study
plan.--At the initiative of the Secretary or the
applicant, the agreed initial pediatric study plan may
be amended at any time. The requirements of paragraph
(2)(C) shall apply to any such proposed amendment in
the same manner and to the same extent as such
requirements apply to an initial pediatric study plan
under paragraph (1). The requirements of paragraphs (3)
and (4) shall apply to any agreement resulting from
such proposed amendment in the same manner and to the
same extent as such requirements apply to an agreed
initial pediatric study plan.
(6) Internal committee.--The Secretary shall consult
the internal committee under section 505C on the review
of the initial pediatric study plan, agreed initial
pediatric study plan, and any significant amendments to
such plans.
(7) Required rulemaking.--Not later than 1 year after
the date of enactment of the Food and Drug
Administration Safety and Innovation Act, the Secretary
shall promulgate proposed regulations and issue
guidance to implement the provisions of this
subsection.
(f) Review of Pediatric Study Plans,Assessments, Deferrals,
Deferral Extensions, 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 initial
pediatric study plans, agreed initial pediatric study
plans, and any significant amendments to such plans,
and assessments prior to approval of an application or
supplement for which a pediatric assessment is required
under this section and all deferral, deferral
extension, 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 study plans, assessments,
deferrals, deferral extensions, and waivers.--
Consultation on initial pediatric study plans, agreed
initial pediatric study 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, deferral extensions, 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) aggregated on an annual basis--
(i) the total number of deferrals and
deferral extensions requested and
granted under this section and, if
granted, the reasons for each such
deferral or deferral extension;
(ii) the timeline for completion of
the assessments;
(iii) the number of assessments
completed and pending; and
(iv) the number of postmarket non-
compliance letters issued pursuant to
subsection (d), and the recipients of
such letters;
(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)(4)(C); 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 that receives
a priority review or 330 days after the date of
the submission of an application or supplement
that receives a standard review--
(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 labeling 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 an application (or supplement to
an application) that contains a pediatric assessment
under this section, if the application (or supplement)
receives a priority review, or not later than 330 days
after the date of submission of an application (or
supplement to an application) that contains a pediatric
assessment under this section, if the application (or
supplement) receives a standard review, 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 first 18-month period.--Beginning on
the date of the enactment of the Pediatric Research
Equity Act of 2007, during the 18-month 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 periods.--Following the
18-month 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) Preservation of authority.--Nothing in this
subsection shall prohibit the Office of Pediatric
Therapeutics from providing for the review of adverse
event reports by the Pediatric Advisory Committee prior
to the 18-month period referred to in paragraph (1), if
such review is necessary to ensure safe use of a drug
in a pediatric population.
(4) 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) Relation to Orphan Drugs.--
(1) In general; exemption for orphan indications.--
Unless the Secretary requires otherwise by regulation
and except as provided in paragraph (2), this section
does not apply to any drug or biological product for an
indication for which orphan designation has been
granted under section 526.
(2) Applicability despite orphan designation of
certain indications.--This section shall apply with
respect to a drug or biological product for which an
indication has been granted orphan designation under
526 if the investigation described in subsection (a)(3)
applies to the drug or biological product as described
in subsection (a)(1)(B).
(l) New Active Ingredient.--
(1) Non-interchangeable biosimilar biological
product.--A biological product that is biosimilar to a
reference product under section 351 of the Public
Health Service Act, and that the Secretary has not
determined to meet the standards described in
subsection (k)(4) of such section for
interchangeability with the reference product, shall be
considered to have a new active ingredient under this
section.
(2) Interchangeable biosimilar biological product.--A
biological product that is interchangeable with a
reference product under section 351 of the Public
Health Service Act shall not be considered to have a
new active ingredient under this section.
(m) List of Primary Molecular Targets.--
(1) In general.--Within one year of the date of
enactment of the FDA Reauthorization Act of 2017, the
Secretary shall establish and update regularly, and
shall publish on the internet website of the Food and
Drug Administration--
(A) a list of molecular targets considered,
on the basis of data the Secretary determines
to be adequate, to be substantially relevant to
the growth and progression of a pediatric
cancer, and that may trigger the requirements
under this section; and
(B) a list of molecular targets of new cancer
drugs and biological products in development
for which pediatric cancer study requirements
under this section will be automatically
waived.
(2) Consultation.--In establishing the lists
described in paragraph (1), the Secretary shall consult
the National Cancer Institute, members of the internal
committee under section 505C, and the Pediatric
Oncology Subcommittee of the Oncologic Drugs Advisory
Committee, and shall take into account comments from
the meeting under subsection (c).
(3) Rule of construction.--Nothing in paragraph (1)
shall be construed--
(A) to require the inclusion of a molecular
target on the list published under such
paragraph as a condition for triggering the
requirements under subsection (a)(1)(B) with
respect to a drug or biological product
directed at such molecular target; or
(B) to authorize the disclosure of
confidential commercial information, as
prohibited under section 301(j) of this Act or
section 1905 of title 18, United States Code.
* * * * * * *
Subchapter B--Drugs for Rare Diseases or Conditions
* * * * * * *
protection for drugs for rare diseases or conditions
Sec. 527. (a) Except as provided in subsection (b), if the
Secretary--
(1) approves an application filed pursuant to section
505, or
(2) issues a license under section 351 of the Public
Health Service Act
for a drug designated under section 526 for a rare disease or
condition, the Secretary may not approve another application
under section 505 or issue another license under section 351 of
the Public Health Service Act for the same drug for the [same
disease or condition] same approved use or indication within
such rare disease or condition for a person who is not the
holder of such approved application or of such license until
the expiration of seven years from the date of the approval of
the approved application or the issuance of the license.
Section 505(c)(2) does not apply to the refusal to approve an
application under the preceding sentence.
(b) During the 7-year period described in subsection (a) for
an approved application under section 505 or license under
section 351 of the Public Health Service Act, the Secretary may
approve an application or issue a license for a drug that is
otherwise the same, as determined by the Secretary, as the
already approved drug for the [same rare disease or condition]
same approved use or indication for which such 7-year period
applies to such already approved or licensed drug if--
(1) the Secretary finds, after providing the holder
of exclusive approval or licensure notice and
opportunity for the submission of views, that during
such period the holder of the exclusive approval or
licensure cannot ensure the availability of sufficient
quantities of the drug to meet the needs, relating to
the approved use or indication, of persons with the
disease or condition for which the drug was designated;
or
(2) the holder provides the Secretary in writing the
consent of such holder for the approval of other
applications or the issuance of other licenses before
the expiration of such seven-year period.
(c) Condition of Clinical Superiority.--
(1) In general.--If a sponsor of a drug that is
designated under section 526 and is otherwise the same,
as determined by the Secretary, as an already approved
or licensed drug is seeking exclusive approval or
exclusive licensure described in subsection (a) for the
[same rare disease or condition as the already approved
drug] same use or indication for which the already
approved or licensed drug was approved or licensed, the
Secretary shall require such sponsor, as a condition of
such exclusive approval or licensure, to demonstrate
that such drug is clinically superior to any already
approved or licensed drug that is the same drug.
(2) Definition.--For purposes of paragraph (1), the
term ``clinically superior'' with respect to a drug
means that the drug provides a significant therapeutic
advantage over and above an already approved or
licensed drug in terms of greater efficacy, greater
safety, or by providing a major contribution to patient
care.
(3) Applicability.--This subsection applies to any
drug designated under section 526 for which an
application was approved under section 505 of this Act
or licensed under section 351 of the Public Health
Service Act after the date of enactment of the FDA
Reauthorization Act of 2017, regardless of the date on
which such drug was designated under section 526.
(d) Regulations.--The Secretary may promulgate regulations
for the implementation of subsection (c). Beginning on the date
of enactment of the FDA Reauthorization Act of 2017, until such
time as the Secretary promulgates regulations in accordance
with this subsection, the Secretary may apply any definitions
set forth in regulations that were promulgated prior to such
date of enactment, to the extent such definitions are not
inconsistent with the terms of this section, as amended by such
Act.
(e) Demonstration of Clinical Superiority Standard.--To
assist sponsors in demonstrating clinical superiority as
described in subsection (c), the Secretary--
(1) upon the designation of any drug under section
526, shall notify the sponsor of such drug in writing
of the basis for the designation, including, as
applicable, any plausible hypothesis offered by the
sponsor and relied upon by the Secretary that the drug
is clinically superior to a previously approved drug;
and
(2) upon granting exclusive approval or licensure
under subsection (a) on the basis of a demonstration of
clinical superiority as described in subsection (c),
shall publish a summary of the clinical superiority
findings.
(f) Approved Use or Indication Defined.--In this section, the
term ``approved use or indication'' means the use or indication
approved under section 505 of this Act or licensed under
section 351 of the Public Health Service Act for a drug
designated under section 526 for a rare disease or condition.
* * * * * * *
SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC
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(b) of the
Prescription Drug User Fee Amendments of 2012.
(2) Priority review voucher.--The term ``priority
review voucher'' means a voucher issued by the
Secretary to the sponsor of a rare pediatric 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(a) of the Public Health Service Act after
the date of approval of the rare pediatric disease
product application.
(3) Rare pediatric disease.--The term ``rare
pediatric disease'' means a disease that meets each of
the following criteria:
(A) The disease is a serious or life-
threatening disease in which the serious or
life-threatening manifestations primarily
affect individuals aged from birth to 18 years,
including age groups often called neonates,
infants, children, and adolescents.
(B) The disease is a rare disease or
condition, within the meaning of section 526.
(4) Rare pediatric disease product application.--The
term ``rare pediatric disease product application''
means a human drug application, as defined in section
735(1), that--
(A) is for a drug or biological product that
is for the prevention or treatment of a rare
pediatric disease;
(B)(i) is for such a drug--
(I) that contains no active moiety
(as defined by the Secretary in section
314.3 of title 21, Code of Federal
Regulations (or any successor
regulations)) that has been previously
approved in any other application under
subsection (b)(1), (b)(2), or (j) of
section 505; and
(II) that is the subject of an
application submitted under section
505(b)(1); or
(ii) is for such a biological product--
(I) that contains no active
ingredient that has been previously
approved in any other application under
section 351(a) or 351(k) of the Public
Health Service Act; and
(II) that is the subject of an
application submitted under section
351(a) of the Public Health Service
Act;
(C) the Secretary deems eligible for priority
review;
(D) that relies on clinical data derived from
studies examining a pediatric population and
dosages of the drug intended for that
population;
(E) that does not seek approval for an adult
indication in the original rare pediatric
disease product application; and
(F) is approved after the date of the
enactment of the Advancing Hope Act of 2016.
(b) Priority Review Voucher.--
(1) In general.--The Secretary shall award a priority
review voucher to the sponsor of a rare pediatric
disease product application upon approval by the
Secretary of such rare pediatric disease product
application.
(2) Transferability.--
(A) In general.--The sponsor of a rare
pediatric disease product application that
receives a priority review voucher under this
section may transfer (including by sale) the
entitlement to such voucher. There is no limit
on the number of times a priority review
voucher may be transferred before such voucher
is used.
(B) Notification of transfer.--Each person to
whom a voucher is transferred shall notify the
Secretary of such change in ownership of the
voucher not later than 30 days after such
transfer.
(3) Limitation.--A sponsor of a rare pediatric
disease product application may not receive a priority
review voucher under this section if the rare pediatric
disease product application was submitted to the
Secretary prior to the date that is 90 days after the
date of enactment of the Prescription Drug User Fee
Amendments of 2012.
(4) Notification.--
(A) Sponsor of a rare pediatric disease
product.--
(i) In general.--Beginning on the
date that is 90 days after the date of
enactment of the Advancing Hope Act of
2016, the sponsor of a rare pediatric
disease product application that
intends to request a priority review
voucher under this section shall notify
the Secretary of such intent upon
submission of the rare pediatric
disease product application that is the
basis of the request for a priority
review voucher.
(ii) Applications submitted but not
yet approved.--The sponsor of a rare
pediatric disease product application
that was submitted and that has not
been approved as of the date of
enactment of the Advancing Hope Act of
2016 shall be considered eligible for a
priority review voucher, if--
(I) such sponsor has
submitted such rare pediatric
disease product application--
(aa) on or after the
date that is 90 days
after the date of
enactment of the
Prescription Drug User
Fee Amendments of 2012;
and
(bb) on or before the
date of enactment of
the Advancing Hope Act
of 2016; and
(II) such application
otherwise meets the criteria
for a priority review voucher
under this section.
(B) Sponsor of a drug application using a
priority review voucher.--
(i) In general.--The sponsor of a
human drug application shall notify the
Secretary not later than 90 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 the user fee to be
assessed in accordance with this
section.
(ii) Transfer after notice.--The
sponsor of a human drug application
that provides notification of the
intent of such sponsor to use the
voucher for the human drug application
under clause (i) may transfer the
voucher after such notification is
provided, if such sponsor has not yet
submitted the human drug application
described in the notification.
(5) Termination of authority.--The Secretary may not
award any priority review vouchers under paragraph (1)
after [December 20, 2024, unless the rare pediatric
disease product application--] September 30, 2029.
[(A) is for a drug that, not later than
December 20, 2024, is designated under
subsection (d) as a drug for a rare pediatric
disease; and
[(B) is, not later than September 30, 2026,
approved under section 505(b)(1) of this Act or
section 351(a) of the Public Health Service
Act.]
(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, based on the difference between--
(A) the average cost incurred by the Food and
Drug Administration in the review of a human
drug application subject to priority review in
the previous fiscal year; and
(B) the average cost incurred by the Food and
Drug Administration in the review of a human
drug application that is not 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, 2012, the amount of the
priority review user fee for that fiscal year.
(4) Payment.--
[(A) In general.--The priority review user
fee required by this subsection shall be due
upon the notification by a sponsor of the
intent of such sponsor to use the voucher, as
specified in subsection (b)(4)(A). All other
user fees associated with the human drug
application shall be due as required by the
Secretary or under applicable law.]
(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(a) of
the Public Health Service Act for which the
priority review voucher is used. All other user
fees associated with the human drug application
shall be due as required by the Secretary or
under applicable law.
(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 appropriations Acts.
(d) Designation Process.--
(1) In general.--Upon the request of the manufacturer
or the sponsor of a new drug, the Secretary may
designate--
(A) the new drug as a drug for a rare
pediatric disease; and
(B) the application for the new drug as a
rare pediatric disease product application.
(2) Request for designation.--The request for a
designation under paragraph (1) shall be made at the
same time a request for designation of orphan disease
status under section 526 or fast-track designation
under section 506 is made. Requesting designation under
this subsection is not a prerequisite to receiving a
priority review voucher under this section.
(3) Determination by secretary.--Not later than 60
days after a request is submitted under paragraph (1),
the Secretary shall determine whether--
(A) the disease or condition that is the
subject of such request is a rare pediatric
disease; and
(B) the application for the new drug is a
rare pediatric disease product application.
(e) Marketing of Rare Pediatric Disease Products.--
(1) Revocation.--The Secretary may revoke any
priority review voucher awarded under subsection (b) if
the rare pediatric disease product for which such
voucher was awarded is not marketed in the United
States within the 365-day period beginning on the date
of the approval of such drug under section 505 of this
Act or section 351 of the Public Health Service Act.
(2) Postapproval production report.--The sponsor of
an approved rare pediatric disease product shall submit
a report to the Secretary not later than 5 years after
the approval of the applicable rare pediatric disease
product application. Such report shall provide the
following information, with respect to each of the
first 4 years after approval of such product:
(A) The estimated population in the United
States suffering from the rare pediatric
disease.
(B) The estimated demand in the United States
for such rare pediatric disease product.
(C) The actual amount of such rare pediatric
disease product distributed in the United
States.
(f) Notice and Report.--
(1) Notice of issuance of voucher and approval of
products under voucher.--The Secretary shall publish a
notice in the Federal Register and on the Internet Web
site of the Food and Drug Administration not later than
30 days after the occurrence of each of the following:
(A) The Secretary issues a priority review
voucher under this section.
(B) The Secretary approves a drug pursuant to
an application submitted under section 505(b)
of this Act or section 351(a) of the Public
Health Service Act for which the sponsor of the
application used a priority review voucher
under this section.
(2) Notification.--If, after the last day of the 1-
year period that begins on the date that the Secretary
awards the third rare pediatric disease priority
voucher under this section, a sponsor of an application
submitted under section 505(b) of this Act or section
351(a) of the Public Health Service Act for a drug uses
a priority review voucher under this section for such
application, the Secretary shall 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 document--
(A) notifying such Committees of the use of
such voucher; and
(B) identifying the drug for which such
priority review voucher is used.
(g) Eligibility for Other Programs.--Nothing in this section
precludes a sponsor who seeks a priority review voucher under
this section from participating in any other incentive program,
including under this Act, except that no sponsor of a rare
pediatric disease product application may receive more than one
priority review voucher issued under any section of this Act
with respect to the drug for which the application is made..
(h) Relation to Other Provisions.--The provisions of this
section shall supplement, not supplant, any other provisions of
this Act or the Public Health Service Act that encourage the
development of drugs for tropical diseases and rare pediatric
diseases.
(i) GAO Study and Report.--
(1) Study.--
(A) In general.--Beginning on the date that
the Secretary awards the third rare pediatric
disease priority voucher under this section,
the Comptroller General of the United States
shall conduct a study of the effectiveness of
awarding rare pediatric disease priority
vouchers under this section in the development
of human drug products that treat or prevent
such diseases.
(B) Contents of study.--In conducting the
study under subparagraph (A), the Comptroller
General shall examine the following:
(i) The indications for which each
rare disease product for which a
priority review voucher was awarded was
approved under section 505 or section
351 of the Public Health Service Act.
(ii) Whether, and to what extent, an
unmet need related to the treatment or
prevention of a rare pediatric disease
was met through the approval of such a
rare disease product.
(iii) The value of the priority
review voucher if transferred.
(iv) Identification of each drug for
which a priority review voucher was
used.
(v) The length of the period of time
between the date on which a priority
review voucher was awarded and the date
on which it was used.
(2) Report.--Not later than 1 year after the date
under paragraph (1)(A), the Comptroller General shall
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
containing the results of the study under paragraph
(1).
* * * * * * *
CHAPTER X--MISCELLANEOUS
* * * * * * *
SEC. 1015. ABRAHAM ACCORDS OFFICE.
(a) In General.--The Secretary, acting through the
Commissioner of Food and Drugs, shall establish within the Food
and Drug Administration an office, to be known as the Abraham
Accords Office, to be headed by a director.
(b) Office.--Not later than two years after the date of
enactment of this section, the Secretary shall--
(1) in consultation with the governments of Abraham
Accords countries, as well as appropriate United States
Government diplomatic and security personnel--
(A) select the location of the Abraham
Accords Office in an Abraham Accords country;
and
(B) establish such office; and
(2) assign to such office such personnel of the Food
and Drug Administration as the Secretary determines
necessary to carry out the functions of such office.
(c) Duties.--The Secretary, acting through the Director of
the Abraham Accords Office, shall--
(1) after the Abraham Accords Office is established--
(A) as part of the Food and Drug
Administration's work to strengthen the
international oversight of regulated
commodities, provide technical assistance to
regulatory partners in Abraham Accords
countries on strengthening regulatory oversight
and converging regulatory requirements for the
oversight of regulated products, including good
manufacturing practices and other issues
relevant to manufacturing medical products that
are regulated by the Food and Drug
Administration; and
(B) facilitate interactions between the Food
and Drug Administration and interested parties
in Abraham Accords countries, including by
sharing relevant information regarding United
States regulatory pathways with such parties,
and facilitate feedback on the research,
development, and manufacturing of products
regulated in accordance with this Act; and
(2) carry out other functions and activities as the
Secretary determines to be necessary to carry out this
section.
(d) Abraham Accords Country Defined.--In this section, the
term ``Abraham Accords country'' means a country identified by
the Department of State as having signed the Abraham Accords
Declaration.
(e) National Security.--Nothing in this section shall be
construed to require any action inconsistent with a national
security recommendation provided by the Federal Government.
----------
FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT
* * * * * * *
TITLE V--PEDIATRIC DRUGS AND DEVICES
* * * * * * *
SEC. 508. REPORT.
(a) In General.--Not later than four years after the date of
enactment of this Act and every five years thereafter, 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, and
make publicly available, including through posting on the
Internet Web site of the Food and Drug Administration, a report
on the implementation of sections 505A and 505B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c).
(b) Contents.--Each report under subsection (a) shall
include--
(1) an assessment of the effectiveness of sections
505A and 505B of the Federal Food, Drug, and Cosmetic
Act in improving information about pediatric uses for
approved drugs and biological products, including the
number and type of labeling changes made since the date
of enactment of this Act and the importance of such
uses in the improvement of the health of children;
(2) the number of required studies under such section
505B that have not met the initial deadline provided
under such section 505B, including--
(A) the number of deferrals and deferral
extensions granted and the reasons such
extensions were granted;
(B) the number of waivers and partial waivers
granted; and
(C) the number of letters issued under
subsection (d) of such section 505B;
(3) an assessment of the timeliness and effectiveness
of pediatric study planning since the date of enactment
of this Act, including the number of initial pediatric
study plans not submitted in accordance with the
requirements of subsection (e) of such section 505B and
any resulting rulemaking;
(4) the number of written requests issued, accepted,
and declined under such section 505A since the date of
enactment of this Act, and a listing of any important
gaps in pediatric information as a result of such
declined requests;
(5) a description and current status of referrals
made under subsection (n) of such section 505A;
(6) an assessment of the effectiveness of studying
biological products in pediatric populations under such
sections 505A and 505B and section 409I of the Public
Health Service Act (42 U.S.C. 284m);
(7)(A) the efforts made by the Secretary to increase
the number of studies conducted in the neonatal
population (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); and
(B) the results of such efforts;
(8)(A) the number and importance of drugs and
biological products for children with cancer that are
being tested as a result of the programs under such
sections 505A and 505B and under section 409I of the
Public Health Service Act; and
(B) any recommendations for modifications to such
programs that would lead to new and better therapies
for children with cancer, including a detailed
rationale for each recommendation;
(9) any recommendations for modification to such
programs that would improve pediatric drug research and
increase pediatric labeling of drugs and biological
products;
(10) an assessment of the successes of and
limitations to studying drugs for rare diseases under
such sections 505A and 505B;
(11) an assessment of the impact of the amendments to
such section 505B made by the FDA Reauthorization Act
of 2017 on pediatric research and labeling of drugs and
biological products and pediatric labeling of
molecularly targeted drugs and biological products for
the treatment of cancer[;], including an evaluation of
compliance with deadlines provided for in deferrals and
deferral extensions;
(12) an assessment of the efforts of the Secretary to
implement the plan developed under section 505C-1 of
the Federal Food, Drug, and Cosmetic Act, regarding
earlier submission of pediatric studies under sections
505A and 505B of such Act and section 351(m) of the
Public Health Service Act, including--
(A) the average length of time after the
approval of an application under section
505(b)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)(1)) or section
351(a) of the Public Health Service Act (42
U.S.C. 262(a)) before studies conducted
pursuant to such section 505A, 505B, or section
351(m) are completed, submitted, and
incorporated into labeling;
(B) the average length of time after the
receipt of a proposed pediatric study request
before the Secretary responds to such request;
(C) the average length of time after the
submission of a proposed pediatric study
request before the Secretary issues a written
request for such studies;
(D) the number of written requests issued for
each investigational new drug or biological
product prior to the submission of an
application under section 505(b)(1) of the
Federal Food, Drug, and Cosmetic Act or section
351(a) of the Public Health Service Act; and
(E) the average number, and range of numbers,
of amendments to written requests issued, and
the time the Secretary requires to review and
act on proposed amendments to written requests;
(13) a list of sponsors of applications or holders of
approved applications who received exclusivity under
such section 505A or such section 351(m) after
receiving a letter issued under such section 505B(d)(1)
for any drug or biological product before the studies
referred to in such letter were completed and
submitted;
(14) a list of assessments and investigations
required under such section 505B;
(15) how many requests under such section 505A for
molecular targeted cancer drugs, as defined by
subsection (a)(1)(B) of such section 505B, approved
prior to 3 years after the date of enactment of the FDA
Reauthorization Act of 2017, have been issued by the
Food and Drug Administration, and how many such
requests have been completed; [and]
(16) the Secretary's assessment of the overall impact
of the amendments made by section 504 of the FDA
Reauthorization Act of 2017 on the conduct and
effectiveness of pediatric cancer research and the
orphan drug program, as well any subsequent
recommendations[.]; and
(17) a listing of penalties, settlements, or payments
under section 303 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353) for failure to comply with
requirements under such section 505B, including, for
each penalty, settlement, or payment, the name of the
drug, the sponsor thereof, and the amount of the
penalty, settlement, or payment imposed.
(c) Stakeholder Comment.--At least 180 days prior to the
submission of each report under subsection (a), the Secretary
shall consult with representatives of patient groups (including
pediatric patient groups), consumer groups, regulated industry,
academia, and other interested parties to obtain any
recommendations or information relevant to the report including
suggestions for modifications that would improve pediatric drug
research and pediatric labeling of drugs and biological
products.
* * * * * * *
----------
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part H--Organ Transplants
* * * * * * *
organ procurement and transplantation network
Sec. 372. (a) In General--The Secretary shall provide for the
continued operation of an Organ Procurement and Transplantation
Network which meets the requirements of subsection (b). The
Secretary may award grants, contracts, or cooperative
agreements, as the Secretary determines appropriate, for
purposes of carrying out this section.
(b) Composition.--
(1) In general.--The Organ Procurement and
Transplantation Network shall--
(A) be operated through awards to public or
private entities made by the Secretary that are
distinct from the awards made to support the
organization tasked with supporting the board
of directors described in subparagraph (B); and
(B) have a board of directors--
(i) that includes representatives of organ
procurement organizations (including
organizations that have received grants under
section 371), transplant centers, voluntary
health associations, and the general public;
and
(ii) that shall establish an executive
committee and other committees, whose
chairpersons shall be selected to ensure
continuity of leadership for the board.
(2) The Organ Procurement and Transplantation Network shall--
(A) establish in one location or through regional
centers--
(i) a national list of individuals who need
organs[, and]; and
(ii) a national system, through the use of
computers and in accordance with established
medical criteria, to match organs and
individuals included in the list, especially
individuals whose immune system makes it
difficult for them to receive organs[,];
(B) establish membership criteria and medical
criteria for allocating organs and provide to members
of the public an opportunity to comment with respect to
such criteria[,];
(C) maintain a [twenty-four-hour telephone service]
24-hour telephone or information technology service to
facilitate matching organs with individuals included in
the list[,];
(D) assist organ procurement organizations in the
nationwide distribution of organs equitably among
transplant patients[,];
(E) adopt and use standards of quality for the
acquisition and transportation of donated organs[,];
(F) prepare and distribute, on a regionalized basis
(and, to the extent practicable, among regions or on a
national basis), samples of blood sera from individuals
who are included on the list and whose immune system
makes it difficult for them to receive organs, in order
to facilitate matching the compatibility of such
individuals with organ donors[,];
(G) coordinate, as appropriate, the transportation of
organs from organ procurement organizations to
transplant centers[,];
(H) provide information to physicians and other
health professionals regarding organ donation[,];
(I) collect, analyze, and publish data concerning
organ donation and transplants[,];
(J) carry out studies and demonstration projects for
the purpose of improving procedures for organ
procurement and allocation[,];
(K) work actively to increase the supply of donated
organs[,];
(L) submit to the Secretary an annual report
containing information on the comparative costs and
patient outcomes at each transplant center affiliated
with the organ procurement and transplantation
network[,];
(M) recognize the differences in health and in organ
transplantation issues between children and adults
throughout the system and adopt criteria, polices, and
procedures that address the unique health care needs of
children[,];
(N) carry out studies and demonstration projects for
the purpose of improving procedures for organ donation
procurement and allocation, including but not limited
to projects to examine and attempt to increase
transplantation among populations with special needs,
including children and individuals who are members of
racial or ethnic minority groups, and among populations
with limited access to [transportation, and]
transportation;
(O) provide that for purposes of this paragraph, the
term ``children'' refers to individuals who are under
the age of 18[.];
(P) encourage the integration of electronic health
records systems through application programming
interfaces (or successor technologies) among hospitals,
organ procurement organizations, and transplant
centers, including the use of automated electronic
hospital referrals and the grant of remote, electronic
access to hospital electronic health records of
potential donors by organ procurement organizations, in
a manner that complies with the privacy regulations
promulgated under the Health Insurance Portability and
Accountability Act of 1996, at part 160 of title 45,
Code of Federal Regulations, and subparts A, C, and E
of part 164 of such title (or any successor
regulations); and
(Q) consider establishing a dashboard to display the
number of transplants performed, the types of
transplants performed, the number and types of organs
that entered the Organ Procurement and Transplantation
Network system and failed to be transplanted, and other
appropriate statistics, which should be updated more
frequently than annually.
(3) Clarification.--In adopting and using standards
of quality under paragraph (2)(E), the Organ
Procurement and Transplantation Network may adopt and
use such standards with respect to organs infected with
human immunodeficiency virus (in this paragraph
referred to as ``HIV''), provided that any such
standards ensure that organs infected with HIV may be
transplanted only into individuals who--
(A) are infected with HIV before receiving
such organ; and
(B)(i) are participating in clinical research
approved by an institutional review board under
the criteria, standards, and regulations
described in subsections (a) and (b) of section
377E; or
(ii) if the Secretary has determined under
section 377E(c) that participation in such
clinical research, as a requirement for such
transplants, is no longer warranted, are
receiving a transplant under the standards and
regulations under section 377E(c).
(c) The Secretary shall establish procedures for--
(1) receiving from interested persons critical
comments relating to the manner in which the Organ
Procurement and Transplantation Network is carrying out
the duties of the Network under subsection (b); and
(2) the consideration by the Secretary of such
critical comments.
(d) Registration Fees.--
(1) In general.--The Secretary may collect
registration fees from any member of the Organ
Procurement and Transplantation Network for each
transplant candidate such member places on the list
described in subsection (b)(2)(A)(i). Such registration
fees shall be collected and distributed only to support
the operation of the Organ Procurement and
Transplantation Network. Such registration fees are
authorized to remain available until expended.
(2) Collection.--The Secretary may collect the
registration fees under paragraph (1) directly or
through awards made under subsection (b)(1)(A).
(3) Distribution.--Any amounts collected under this
subsection shall--
(A) be credited to the currently applicable
appropriation, account, or fund of the
Department of Health and Human Services as
discretionary offsetting collections; and
(B) be available, only to the extent and in
the amounts provided in advance in
appropriations Acts, to distribute such fees
among awardees described in subsection
(b)(1)(A).
(4) Transparency.--The Secretary shall--
(A) promptly post on the website of the Organ
Procurement and Transplantation Network--
(i) the amount of registration fees
collected under this subsection from
each member of the Organ Procurement
and Transplantation Network; and
(ii) a list of activities such fees
are used to support; and
(B) update the information posted pursuant to
subparagraph (A), as applicable for each
calendar quarter for which fees are collected
under paragraph (1).
(5) GAO review.--Not later than 2 years after the
date of enactment of this subsection, the Comptroller
General of the United States shall, to the extent data
are available--
(A) conduct a review concerning the
activities under this subsection; and
(B) submit to the Committee on Health,
Education, Labor, and Pensions and the
Committee on Finance of the Senate and the
Committee on Energy and Commerce of the House
of Representatives, a report on such review,
including related recommendations, as
applicable.
(6) Sunset.--The authority to collect registration
fees under paragraph (1) shall expire on the date that
is 3 years after the date of enactment of the Give Kids
a Chance Act of 2025.
* * * * * * *
TITLE IV--NATIONAL RESEARCH INSTITUTES
* * * * * * *
Part B--General Provisions Respecting National Research Institutes
* * * * * * *
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, biological products, 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--
(A) shall consider--
(i) 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;
(ii) particular pediatric diseases,
disorders or conditions where more
complete knowledge and testing of
therapeutics, including drugs and
biologics, and identification of
biomarkers for such diseases,
disorders, or conditions, may be
beneficial in pediatric populations;
and
(iii) the adequacy of necessary
infrastructure to conduct pediatric
pharmacological research, including
research networks and trained pediatric
investigators; and
(B) may consider the availability of
qualified countermeasures (as defined in
section 319F-1), security countermeasures (as
defined in section 319F-2), and qualified
pandemic or epidemic products (as defined in
section 319F-3) to address the needs of
pediatric populations, in consultation with the
Assistant Secretary for Preparedness and
Response, consistent with the purposes of this
section.
(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
paragraphs (1) and (2)(A) of 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, or section 351(m) of this
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 section 351(k) of this Act; or
(ii) there is a submitted application that
could be approved under the criteria of such
section; and
(B) there remains no patent listed pursuant
to section 505(b)(1) of the Federal Food, Drug,
and Cosmetic Act, and every three-year and
five-year period referred to in subsection
(c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv),
(j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv)
of section 505 of the Federal Food, Drug, and
Cosmetic Act, or applicable twelve-year period
referred to in section 351(k)(7) of this Act,
and any seven-year period referred to in
section 527 of the Federal Food, Drug, and
Cosmetic Act has ended for at least one form of
the drug; 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.--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.
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 the
Federal Food, Drug, and Cosmetic Act or section 351(m)
of this 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.--
(i) In general.--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 not later than 90 days after
submission of such report, shall be--
(I) posted on the internet
website of the National
Institutes of Health in a
manner that is accessible and
consistent with all applicable
Federal laws and regulations,
including such laws and
regulations for the protection
of--
(aa) human research
participants, including
with respect to
privacy, security,
informed consent, and
protected health
information; and
(bb) proprietary
interests, confidential
commercial information,
and intellectual
property rights; and
(II) assigned a docket number
by the Commissioner of Food and
Drugs and made available for
the submission of public
comments.
(ii) Submission of comments.--An
interested person may submit written
comments concerning such pediatric
studies to the Commissioner of Food and
Drugs, and the submitted 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 action in a timely
and appropriate manner in response to the
reports submitted under subparagraph (A), and
shall begin such action upon receipt of the
report under subparagraph (A), in accordance
with paragraph (7).
(7) Requests for labeling change.--Within 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) include in the public docket file a
reference to the location of the report on the
internet website of the National Institutes of
Health and a copy of any requested labeling
changes; and
(ii) publish 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) Authorization of Appropriations.--
(1) In general.--There are authorized to be
appropriated to carry out this [section, $5,753,425 for
the period beginning on October 1, 2022 and ending on
December 23, 2022.] section, $25,000,000 for each of
fiscal years 2026 through 2028.
(2) Availability.--Any amount appropriated under
paragraph (1) shall remain available to carry out this
section until expended.
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SOCIAL SECURITY ACT
* * * * * * *
TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED
* * * * * * *
Part E--Miscellaneous Provisions
* * * * * * *
medicare improvement fund
Sec. 1898.
(a) Establishment.--The Secretary shall establish under this
title a Medicare Improvement Fund (in this section referred to
as the ``Fund'') which shall be available to the Secretary to
make improvements under the original Medicare fee-for-service
program under parts A and B for individuals entitled to, or
enrolled for, benefits under part or enrolled under part B
including adjustments to payments for items and services
furnished by providers of services and suppliers under such
original Medicare fee-for-service program.
(b) Funding.--
(1) In general.--There shall be available to the
Fund, for expenditures from the Fund for services
furnished during and after [fiscal year 2026] fiscal
year 2027, [$1,804,000,000] $3,047,000,000.
(2) Payment from trust funds.--The amount specified
under paragraph (1) shall be available to the Fund, as
expenditures are made from the Fund, from the Federal
Hospital Insurance Trust Fund and the Federal
Supplementary Medical Insurance Trust Fund in such
proportion as the Secretary determines appropriate.
(3) Funding limitation.--Amounts in the Fund shall be
available in advance of appropriations but only if the
total amount obligated from the Fund does not exceed
the amount available to the Fund under paragraph (1).
The Secretary may obligate funds from the Fund only if
the Secretary determines (and the Chief Actuary of the
Centers for Medicare & Medicaid Services and the
appropriate budget officer certify) that there are
available in the Fund sufficient amounts to cover all
such obligations incurred consistent with the previous
sentence.
(4) No effect on payments in subsequent years.--In
the case that expenditures from the Fund are applied
to, or otherwise affect, a payment rate for an item or
service under this title for a year, the payment rate
for such item or service shall be computed for a
subsequent year as if such application or effect had
never occurred.
* * * * * * *