[Congressional Record Volume 168, Number 97 (Tuesday, June 7, 2022)]
[House]
[Pages H5298-H5321]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
{time} 1815
FOOD AND DRUG AMENDMENTS OF 2022
Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 7667) to amend the Federal Food, Drug, and Cosmetic Act to
revise and extend the user-fee programs for prescription drugs, medical
devices, generic drugs, and biosimilar biological products, and for
other purposes, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 7667
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food and Drug Amendments of
2022''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--FEES RELATING TO DRUGS
Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Sunset dates.
Sec. 106. Effective date.
Sec. 107. Savings clause.
TITLE II--FEES RELATING TO DEVICES
Sec. 201. Short title; finding.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Conformity assessment pilot program.
Sec. 206. Reauthorization of third-party review program.
Sec. 207. Sunset dates.
Sec. 208. Effective date.
Sec. 209. Savings clause.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 301. Short title; finding.
Sec. 302. Authority to assess and use human generic drug fees.
Sec. 303. Reauthorization; reporting requirements.
Sec. 304. Sunset dates.
Sec. 305. Effective date.
Sec. 306. Savings clause.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 401. Short title; finding.
Sec. 402. Definitions.
Sec. 403. Authority to assess and use biosimilar fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.
TITLE V--IMPROVING DIVERSITY IN CLINICAL STUDIES
Sec. 501. Diversity action plans for clinical studies.
Sec. 502. Evaluation of the need for FDA authority to mandate
postapproval studies or postmarket surveillance due to
insufficient demographic subgroup data.
Sec. 503. Public workshops to enhance clinical study diversity.
Sec. 504. Annual summary report on progress to increase diversity in
clinical studies.
Sec. 505. Public meeting on clinical study flexibilities initiated in
response to COVID-19 pandemic.
Sec. 506. Decentralized clinical studies.
TITLE VI--GENERIC DRUG COMPETITION
Sec. 601. Increasing transparency in generic drug applications.
Sec. 602. Enhancing access to affordable medicines.
TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS
Subtitle A--In General
Sec. 701. Animal testing alternatives.
Sec. 702. Emerging technology program.
Sec. 703. Improving the treatment of rare diseases and conditions.
Sec. 704. Antifungal research and development.
Sec. 705. Advancing qualified infectious disease product innovation.
Sec. 706. National Centers of Excellence in Advanced and Continuous
Pharmaceutical Manufacturing.
Sec. 707. Advanced manufacturing technologies designation pilot
program.
Sec. 708. Public workshop on cell therapies.
Sec. 709. Reauthorization of best pharmaceuticals for children.
Sec. 710. Reauthorization for humanitarian device exemption and
demonstration grants for improving pediatric
availability.
Sec. 711. Reauthorization of provision related to exclusivity of
certain drugs containing single enantiomers.
Sec. 712. Reauthorization of the critical path public-private
partnership program.
Sec. 713. Reauthorization of orphan drug grants.
Sec. 714. Research into pediatric uses of drugs; additional authorities
of Food and Drug Administration regarding molecularly
targeted cancer drugs.
Subtitle B--Inspections
Sec. 721. Factory inspection.
Sec. 722. Uses of certain evidence.
Sec. 723. Improving FDA inspections.
Sec. 724. GAO report on inspections of foreign establishments
manufacturing drugs.
Sec. 725. Unannounced foreign facility inspections pilot program.
Sec. 726. Reauthorization of inspection program.
Sec. 727. Enhancing intra-agency coordination and public health
assessment with regard to compliance activities.
Sec. 728. Reporting of mutual recognition agreements for inspections
and review activities.
Sec. 729. Enhancing transparency of drug facility inspection timelines.
TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY
IMPROVEMENTS
Sec. 801. Prompt reports of marketing status by holders of approved
applications for biological products.
Sec. 802. Encouraging blood donation.
Sec. 803. Regulation of certain products as drugs.
Sec. 804. Postapproval studies and program integrity for accelerated
approval drugs.
Sec. 805. Facilitating the use of real world evidence.
Sec. 806. Dual Submission for Certain Devices.
Sec. 807. Medical Devices Advisory Committee meetings.
Sec. 808. Ensuring cybersecurity of medical devices.
Sec. 809. Public docket on proposed changes to third-party vendors.
Sec. 810. Facilitating exchange of product information prior to
approval.
Sec. 811. Bans of devices for one or more intended uses.
Sec. 812. Clarifying application of exclusive approval, certification,
or licensure for drugs designated for rare diseases or
conditions.
Sec. 813. GAO report on third-party review.
Sec. 814. Reporting on pending generic drug applications and priority
review applications.
Sec. 815. FDA Workforce Improvements.
TITLE IX--MISCELLANEOUS
Sec. 901. Determination of budgetary effects.
Sec. 902. Medicaid Improvement Fund.
TITLE I--FEES RELATING TO DRUGS
SEC. 101. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the
``Prescription Drug User Fee Amendments of 2022''.
(b) Finding.--The Congress finds that the fees authorized
by the amendments made by this title will be dedicated toward
expediting the drug development process and the process for
the review of human drug applications, including postmarket
drug safety activities, as set forth in the goals identified
for purposes of part 2 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et
seq.), in the letters from the Secretary of Health and Human
Services to the Chairman of the Committee on Health,
Education, Labor, and Pensions of the Senate and the Chairman
of the Committee on Energy and Commerce of the House of
Representatives, as set forth in the Congressional Record.
SEC. 102. DEFINITIONS.
(a) Human Drug Application.--Section 735(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is amended
by striking ``an allergenic extract product, or'' and
inserting ``does not include an application with respect to
an allergenic extract
[[Page H5299]]
product licensed before October 1, 2022, does not include an
application with respect to a standardized allergenic extract
product submitted pursuant to a notification to the applicant
from the Secretary regarding the existence of a potency test
that measures the allergenic activity of an allergenic
extract product licensed by the applicant before October 1,
2022, does not include an application with respect to''.
(b) Prescription Drug Product.--Section 735(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(3)) is
amended--
(1) by redesignating subparagraphs (A), (B), and (C) as
clauses (i), (ii), and (iii), respectively;
(2) by striking ``(3) The term'' and inserting ``(3)(A) The
term'';
(3) by striking ``Such term does not include whole blood''
and inserting the following:
``(B) Such term does not include whole blood'';
(4) by striking ``an allergenic extract product,'' and
inserting ``an allergenic extract product licensed before
October 1, 2022, a standardized allergenic extract product
submitted pursuant to a notification to the applicant from
the Secretary regarding the existence of a potency test that
measures the allergenic activity of an allergenic extract
product licensed by the applicant before October 1, 2022,'' ;
and
(5) by adding at the end the following:
``(C)(i) If a written request to place a product in the
discontinued section of either of the lists referenced in
subparagraph (A)(iii) is submitted to the Secretary on behalf
of an applicant, and the request identifies the date the
product is withdrawn from sale, then for purposes of
assessing the prescription drug program fee under section
736(a)(2), the Secretary shall consider such product to have
been included in the discontinued section on the later of--
``(I) the date such request was received; or
``(II) if the product will be withdrawn from sale on a
future date, such future date when the product is withdrawn
from sale.
``(ii) For purposes of this subparagraph, a product shall
be considered withdrawn from sale once the applicant has
ceased its own distribution of the product, whether or not
the applicant has ordered recall of all previously
distributed lots of the product, except that a routine,
temporary interruption in supply shall not render a product
withdrawn from sale.''.
(c) Skin-Test Diagnostic Product.--Section 735 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) is
amended by adding at the end the following:
``(12) The term `skin-test diagnostic product'--
``(A) means a product--
``(i) for prick, scratch, intradermal, or subcutaneous
administration;
``(ii) expected to produce a limited, local reaction at the
site of administration (if positive), rather than a systemic
effect;
``(iii) not intended to be a preventive or therapeutic
intervention; and
``(iv) intended to detect an immediate- or delayed-type
skin hypersensitivity reaction to aid in the diagnosis of--
``(I) an allergy to an antimicrobial agent;
``(II) an allergy that is not to an antimicrobial agent, if
the diagnostic product was authorized for marketing prior to
October 1, 2022; or
``(III) infection with fungal or mycobacterial pathogens;
and
``(B) includes positive and negative controls required to
interpret the results of a product described in subparagraph
(A).''.
SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--
(1) Human drug application fee.--Section 736(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is
amended--
(A) in the matter preceding paragraph (1), by striking
``fiscal year 2018'' and inserting ``fiscal year 2023'';
(B) in paragraph (1)(A), by striking ``(c)(5)'' each place
it appears and inserting ``(c)(6)'';
(C) in paragraph (1)(C), by inserting ``prior to approval''
after ``or was withdrawn''; and
(D) in paragraph (1), by adding at the end the following:
``(H) Exception for skin-test diagnostic products.--A human
drug application for a skin-test diagnostic product shall not
be subject to a fee under subparagraph (A).''.
(2) Prescription drug program fee.--Section 736(a)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(a)(2)) is amended--
(A) in subparagraph (A)--
(i) by striking ``Except as provided in subparagraphs (B)
and (C)'' and inserting the following:
``(i) Fee.--Except as provided in subparagraphs (B) and
(C)'';
(ii) by striking ``subsection (c)(5)'' and inserting
``subsection (c)(6)''; and
(iii) by adding at the end the following:
``(ii) Special rule.--If a drug product that is identified
in a human drug application approved as of October 1 of a
fiscal year is not a prescription drug product as of that
date because the drug product is in the discontinued section
of a list referenced in section 735(3)(A)(iii), and on any
subsequent day during such fiscal year the drug product is a
prescription drug product, then except as provided in
subparagraphs (B) and (C), each person who is named as the
applicant in a human drug application with respect to such
product, and who, after September 1, 1992, had pending before
the Secretary a human drug application or supplement, shall
pay the annual prescription drug program fee established for
a fiscal year under subsection (c)(6) for such prescription
drug product. Such fee shall be due on the last business day
of such fiscal year and shall be paid only once for each such
product for a fiscal year in which the fee is payable.''; and
(B) by amending subparagraph (B) to read as follows:
``(B) Exception for certain prescription drug products.--A
prescription drug program fee shall not be assessed for a
prescription drug product under subparagraph (A) if such
product is--
``(i) a large volume parenteral product (a sterile aqueous
drug product packaged in a single-dose container with a
volume greater than or equal to 100 mL, not including powders
for reconstitution or pharmacy bulk packages) identified on
the list compiled under section 505(j)(7);
``(ii) pharmaceutically equivalent (as defined in section
314.3 of title 21, Code of Federal Regulations (or any
successor regulation)) to another product on the list of
products compiled under section 505(j)(7) (not including the
discontinued section of such list); or
``(iii) a skin-test diagnostic product.''.
(b) Fee Revenue Amounts.--
(1) In general.--Paragraph (1) of section 736(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is
amended to read as follows:
``(1) In general.--For each of the fiscal years 2023
through 2027, fees under subsection (a) shall, except as
provided in subsections (c), (d), (f), and (g), be
established to generate a total revenue amount under such
subsection that is equal to the sum of--
``(A) the annual base revenue for the fiscal year (as
determined under paragraph (3));
``(B) the dollar amount equal to the inflation adjustment
for the fiscal year (as determined under subsection (c)(1));
``(C) the dollar amount equal to the strategic hiring and
retention adjustment for the fiscal year (as determined under
subsection (c)(2));
``(D) the dollar amount equal to the capacity planning
adjustment for the fiscal year (as determined under
subsection (c)(3));
``(E) the dollar amount equal to the operating reserve
adjustment for the fiscal year, if applicable (as determined
under subsection (c)(4));
``(F) the dollar amount equal to the additional direct cost
adjustment for the fiscal year (as determined under
subsection (c)(5)); and
``(G) additional dollar amounts for each fiscal year as
follows:
``(i) $65,773,693 for fiscal year 2023.
``(ii) $25,097,671 for fiscal year 2024.
``(iii) $14,154,169 for fiscal year 2025.
``(iv) $4,864,860 for fiscal year 2026.
``(v) $1,314,620 for fiscal year 2027.''.
(2) Annual base revenue.--Paragraph (3) of section 736(b)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(b)) is amended to read as follows:
``(3) Annual base revenue.--For purposes of paragraph (1),
the dollar amount of the annual base revenue for a fiscal
year shall be--
``(A) for fiscal year 2023, $1,151,522,958; and
``(B) for fiscal years 2024 through 2027, the dollar amount
of the total revenue amount established under paragraph (1)
for the previous fiscal year, not including any adjustments
made under subsection (c)(4) or (c)(5).''.
(c) Adjustments; Annual Fee Setting.--
(1) Inflation adjustment.--Section 736(c)(1)(B)(ii) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(c)(1)(B)(ii)) is amended by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
Arlington-Alexandria, DC-VA-MD-WV''.
(2) Strategic hiring and retention adjustment.--Section
736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(c)) is amended--
(A) by redesignating paragraphs (2) through (6) as
paragraphs (3) through (7), respectively; and
(B) by inserting after paragraph (1) the following:
``(2) Strategic hiring and retention adjustment.--For each
fiscal year, after the annual base revenue established in
subsection (b)(1)(A) is adjusted for inflation in accordance
with paragraph (1), the Secretary shall further increase the
fee revenue and fees by the following amounts:
``(A) For fiscal year 2023, $9,000,000.
``(B) For each of fiscal years 2024 through 2027,
$4,000,000.''.
(3) Capacity planning adjustment.--Paragraph (3), as
redesignated, of section 736(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as
follows:
``(3) Capacity planning adjustment.--
``(A) In general.--For each fiscal year, after the annual
base revenue established in subsection (b)(1)(A) is adjusted
in accordance with paragraphs (1) and (2), such revenue shall
be adjusted further for such fiscal year, in accordance with
this paragraph, to reflect changes in the resource capacity
needs of the Secretary for the process for the review of
human drug applications.
``(B) Methodology.--For purposes of this paragraph, the
Secretary shall employ the capacity planning methodology
utilized by the Secretary in setting fees for fiscal year
2021, as described in the notice titled `Prescription Drug
User Fee Rates for Fiscal Year 2021' published in the Federal
Register
[[Page H5300]]
on August 3, 2020 (85 Fed. Reg. 46651). The workload
categories used in applying such methodology in forecasting
shall include only the activities described in that notice
and, as feasible, additional activities that are also
directly related to the direct review of applications and
supplements, including additional formal meeting types, the
direct review of postmarketing commitments and requirements,
the direct review of risk evaluation and mitigation
strategies, and the direct review of annual reports for
approved prescription drug products. Subject to the
exceptions in the preceding sentence, the Secretary shall not
include as workload categories in applying such methodology
in forecasting any non-core review activities, including
those activities that the Secretary referenced for potential
future use in such notice but did not utilize in setting fees
for fiscal year 2021.
``(C) Limitation.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue for a
fiscal year that is less than the sum of the amounts under
subsections (b)(1)(A) (the annual base revenue for the fiscal
year), (b)(1)(B) (the dollar amount of the inflation
adjustment for the fiscal year), and (b)(1)(C) (the dollar
amount of the strategic hiring and retention adjustment for
the fiscal year).
``(D) Publication in federal register.--The Secretary shall
publish in the Federal Register notice under paragraph (6) of
the fee revenue and fees resulting from the adjustment and
the methodologies under this paragraph.''.
(4) Operating reserve adjustment.--Paragraph (4), as
redesignated, of section 736(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(c)) is amended--
(A) by amending subparagraph (A) to read as follows:
``(A) Increase.--For fiscal year 2023 and subsequent fiscal
years, the Secretary shall, in addition to adjustments under
paragraphs (1), (2), and (3), further increase the fee
revenue and fees if such an adjustment is necessary to
provide for operating reserves of carryover user fees for the
process for the review of human drug applications for each
fiscal year in at least the following amounts:
``(i) For fiscal year 2023, at least 8 weeks of operating
reserves.
``(ii) For fiscal year 2024, at least 9 weeks of operating
reserves.
``(iii) For fiscal year 2025 and subsequent fiscal years,
at least 10 weeks of operating reserves.''; and
(B) in subparagraph (C), by striking ``paragraph (5)'' and
inserting ``paragraph (6)''.
(5) Additional direct cost adjustment.--Paragraph (5), as
redesignated, of section 736(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(c)) is amended to read as
follows:
``(5) Additional direct cost adjustment.--
``(A) Increase.--The Secretary shall, in addition to
adjustments under paragraphs (1), (2), (3), and (4), further
increase the fee revenue and fees--
``(i) for fiscal year 2023, by $44,386,150; and
``(ii) for each of fiscal years 2024 through 2027, by the
amount set forth in clauses (i) through (iv) of subparagraph
(B), as applicable, multiplied by the Consumer Price Index
for urban consumers (Washington-Arlington-Alexandria, DC-VA-
MD-WV; Not Seasonally Adjusted; All Items; Annual Index) for
the most recent year of available data, divided by such Index
for 2021.
``(B) Applicable amounts.--The amounts referred to in
subparagraph (A)(ii) are the following:
``(i) For fiscal year 2024, $60,967,993.
``(ii) For fiscal year 2025, $35,799,314.
``(iii) For fiscal year 2026, $35,799, 314.
``(iv) For fiscal year 2027, $35,799,314.''.
(6) Annual fee setting.--Paragraph (6), as redesignated, of
section 736(c) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379h(c)) is amended by striking ``September 30,
2017'' and inserting ``September 30, 2022''.
(d) Crediting and Availability of Fees.--Section 736(g)(3)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379h(g)(3)) is amended by striking ``fiscal years 2018
through 2022'' and inserting ``fiscal years 2023 through
2027''.
(e) Written Requests for Waivers, Reductions, Exemptions,
and Returns; Disputes Concerning Fees.--Section 736(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(i)) is
amended to read as follows:
``(i) Written Requests for Waivers, Reductions, Exemptions,
and Returns; Disputes Concerning Fees.--To qualify for
consideration for a waiver or reduction under subsection (d),
an exemption under subsection (k), or the return of any fee
paid under this section, including if the fee is claimed to
have been paid in error, a person shall--
``(1) not later than 180 days after such fee is due, submit
to the Secretary a written request justifying such waiver,
reduction, exemption, or return; and
``(2) include in the request any legal authorities under
which the request is made.''.
(f) Orphan Drugs.--Section 736(k) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is amended--
(1) in paragraph (1)(B), by striking ``during the previous
year'' and inserting ``as determined under paragraph (2)'';
and
(2) by amending paragraph (2) to read as follows:
``(2) Evidence of qualification.--An exemption under
paragraph (1) applies with respect to a drug only if the
applicant involved submits a certification that the
applicant's gross annual revenues did not exceed $50,000,000
for the last calendar year ending prior to the fiscal year
for which the exemption is requested. Such certification
shall be supported by--
``(A) tax returns submitted to the United States Internal
Revenue Service; or
``(B) as necessary, other appropriate financial
information.''.
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 736B of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379h-2) is amended--
(1) in subsection (a)(1), by striking ``Beginning with
fiscal year 2018, not'' and inserting ``Not'';
(2) by striking ``Prescription Drug User Fee Amendments of
2017'' each place it appears and inserting ``Prescription
Drug User Fee Amendments of 2022'';
(3) in subsection (a)(3)(A), by striking ``Not later than
30 calendar days after the end of the second quarter of
fiscal year 2018, and not later than 30 calendar days after
the end of each quarter of each fiscal year thereafter'' and
inserting ``Not later than 30 calendar days after the end of
each quarter of each fiscal year for which fees are collected
under this part'';
(4) in subsection (a)(3)(B), by adding at the end the
following:
``(v) For fiscal years 2023 and 2024, of the meeting
requests from sponsors for which the Secretary has determined
that a face-to-face meeting is appropriate, the number of
face-to-face meetings requested by sponsors to be conducted
in person (in such manner as the Secretary shall prescribe on
the internet website of the Food and Drug Administration),
and the number of such in-person meetings granted by the
Secretary.'';
(5) in subsection (a)(4), by striking ``Beginning with
fiscal year 2020, the'' and inserting ``The'';
(6) in subsection (b), by striking ``Beginning with fiscal
year 2018, not'' and inserting ``Not'';
(7) in subsection (c), by striking ``Beginning with fiscal
year 2018, for'' and inserting ``For''; and
(8) in subsection (f)--
(A) in paragraph (1), in the matter preceding subparagraph
(A), by striking ``fiscal year 2022'' and inserting ``fiscal
year 2027''; and
(B) in paragraph (5), by striking ``January 15, 2022'' and
inserting ``January 15, 2027''.
SEC. 105. SUNSET DATES.
(a) Authorization.--Sections 735 and 736 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall
cease to be effective October 1, 2027.
(b) Reporting Requirements.--Section 736B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2) shall cease
to be effective January 31, 2028.
(c) Previous Sunset Provision.--Effective October 1, 2022,
subsections (a) and (b) of section 104 of the FDA
Reauthorization Act of 2017 (Public Law 115-52) are repealed.
SEC. 106. EFFECTIVE DATE.
The amendments made by this title shall take effect on
October 1, 2022, or the date of the enactment of this Act,
whichever is later, except that fees under part 2 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379g et seq.) shall be assessed for
all human drug applications received on or after October 1,
2022, regardless of the date of the enactment of this Act.
SEC. 107. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 2
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379g et seq.), as in effect on the
day before the date of the enactment of this title, shall
continue to be in effect with respect to human drug
applications and supplements (as defined in such part as of
such day) that on or after October 1, 2017, but before
October 1, 2022, were accepted by the Food and Drug
Administration for filing with respect to assessing and
collecting any fee required by such part for a fiscal year
prior to fiscal year 2023.
TITLE II--FEES RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Medical
Device User Fee Amendments of 2022''.
(b) Finding.--The Congress finds that the fees authorized
under the amendments made by this title will be dedicated
toward expediting the process for the review of device
applications and for assuring the safety and effectiveness of
devices, as set forth in the goals identified for purposes of
part 3 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), in the
letters from the Secretary of Health and Human Services to
the Chairman of the Committee on Health, Education, Labor,
and Pensions of the Senate and the Chairman of the Committee
on Energy and Commerce of the House of Representatives, as
set forth in the Congressional Record.
SEC. 202. DEFINITIONS.
Section 737 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379i) is amended--
(1) in paragraph (9)--
(A) in the matter preceding subparagraph (A), by striking
``and premarket notification submissions'' and inserting
``premarket notification submissions, and de novo
classification requests'';
(B) in subparagraph (D), by striking ``and submissions''
and inserting ``submissions, and requests'';
[[Page H5301]]
(C) in subparagraph (F), by striking ``and premarket
notification submissions'' and inserting ``premarket
notification submissions, and de novo classification
requests'';
(D) in each of subparagraphs (G) and (H), by striking ``or
submissions'' and inserting ``submissions, or requests''; and
(E) in subparagraph (K), by striking ``or premarket
notification submissions'' and inserting ``premarket
notification submissions, or de novo classification
requests''; and
(2) in paragraph (11), by striking ``2016'' and inserting
``2021''.
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.
(a) Types of Fees.--Section 738(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is amended--
(1) in paragraph (1), by striking ``fiscal year 2018'' and
inserting ``fiscal year 2023''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by striking
``October 1, 2017'' and inserting ``October 1, 2022'';
(ii) in clause (iii), by striking ``75 percent'' and
inserting ``80 percent''; and
(iii) in clause (viii), by striking ``3.4 percent'' and
inserting ``4.5 percent'';
(B) in subparagraph (B)(iii), by striking ``or premarket
notification submission'' and inserting ``premarket
notification submission, or de novo classification request'';
and
(C) in subparagraph (C), by striking ``or periodic
reporting concerning a class III device'' and inserting
``periodic reporting concerning a class III device, or de
novo classification request''.
(b) Fee Amounts.--Section 738(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j(b)) is amended--
(1) in paragraph (1), by striking ``2018 through 2022'' and
inserting ``2023 through 2027'';
(2) by amending paragraph (2) to read as follows:
``(2) Base fee amounts specified.--For purposes of
paragraph (1), the base fee amounts specified in this
paragraph are as follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2023 Year 2024 Year 2025 Year 2026 Year 2027
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $425,000 $435,000 $445,000 $455,000 $470,000
Establishment Registration............................... $6,250 $6,875 $7,100 $7,575 $8,465'';
and
----------------------------------------------------------------------------------------------------------------
(3) by amending paragraph (3) to read as follows:
``(3) Total revenue amounts specified.--For purposes of
paragraph (1), the total revenue amounts specified in this
paragraph are as follows:
``(A) $312,606,000 for fiscal year 2023.
``(B) $335,750,000 for fiscal year 2024.
``(C) $350,746,400 for fiscal year 2025.
``(D) $366,486,300 for fiscal year 2026.
``(E) $418,343,000 for fiscal year 2027.''.
(c) Annual Fee Setting; Adjustments.--Section 738(c) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is
amended--
(1) in paragraph (1), by striking ``2017'' and inserting
``2022'';
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``2018'' and inserting
``2023'';
(B) in subparagraph (B)--
(i) in the matter preceding clause (i), by striking
``fiscal year 2018'' and inserting ``fiscal year 2023''; and
(ii) in clause (ii), by striking ``fiscal year 2016'' and
inserting ``fiscal year 2022'';
(C) in subparagraph (C), by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
Arlington-Alexandria, DC-VA-MD-WV''; and
(D) in subparagraph (D), in the matter preceding clause
(i), by striking ``fiscal years 2018 through 2022'' and
inserting ``fiscal years 2023 through 2027'';
(3) in paragraph (3), by striking ``2018 through 2022'' and
inserting ``2023 through 2027'';
(4) by redesignating paragraphs (4) and (5) as paragraphs
(7) and (8), respectively; and
(5) by inserting after paragraph (3) the following:
``(4) Performance improvement adjustment.--
``(A) In general.--For each of fiscal years 2025 through
2027, after the adjustments under paragraphs (2) and (3), the
base establishment registration fee amounts for such fiscal
year shall be increased to reflect changes in the resource
needs of the Secretary due to improved review performance
goals for the process for the review of device applications
identified in the letters described in section 201(b) of the
Medical Device User Fee Amendments of 2022, as the Secretary
determines necessary to achieve an increase in total fee
collections for such fiscal year equal to the following
amounts:
``(i) For fiscal year 2025, the product of--
``(I) the amount determined under subparagraph (B)(i)(I);
and
``(II) the applicable inflation adjustment under paragraph
(2)(B) for such fiscal year.
``(ii) For fiscal year 2026, the product of--
``(I) the sum of the amounts determined under subparagraphs
(B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and
``(II) the applicable inflation adjustment under paragraph
(2)(B) for such fiscal year.
``(iii) For fiscal year 2027, the product of--
``(I) the sum of the amounts determined under subparagraphs
(B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and
``(II) the applicable inflation adjustment under paragraph
(2)(B) for such fiscal year.
``(B) Amounts.--
``(i) Pre-submission amount.--For purposes of subparagraph
(A), with respect to the pre-submission written feedback
goal, the amounts determined under this subparagraph are as
follows:
``(I) For fiscal year 2025, $15,396,600 if such goal for
fiscal year 2023 is met.
``(II) For fiscal year 2026:
``(aa) $15,396,600 if such goal for fiscal year 2023 is met
and such goal for fiscal year 2024 is not met.
``(bb) $36,792,200 if such goal for fiscal year 2024 is
met.
``(III) For fiscal year 2027:
``(aa) $15,396,600 if such goal for fiscal year 2023 is met
and such goal for each of fiscal years 2024 and 2025 is not
met.
``(bb) $36,792,200 if such goal for fiscal year 2024 is met
and such goal for fiscal year 2025 is not met.
``(cc) $40,572,600 if such goal for fiscal year 2025 is
met.
``(ii) De novo classification amount.--For purposes of
subparagraph (A), with respect to the de novo decision goal,
the amounts determined under this subparagraph are as
follows:
``(I) For fiscal year 2026, $6,323,500 if such goal for
fiscal year 2023 is met.
``(II) For fiscal year 2027:
``(aa) $6,323,500 if such goal for fiscal year 2023 is met
and such goal for fiscal year 2024 is not met.
``(bb) $11,765,400 if such goal for fiscal year 2024 is
met.
``(iii) Premarket notification and premarket approval
amount.--For purposes of subparagraph (A), with respect to
the 510(k) decision goal, 510(k) shared outcome total time to
decision goal, PMA decision goal, and PMA shared outcome
total time to decision goal, the amounts determined under
this subparagraph are as follows:
``(I) For fiscal year 2026, $1,020,000 if the four goals
for fiscal year 2023 are met.
``(II) For fiscal year 2027:
``(aa) $1,020,000 if the four goals for fiscal year 2023
are met and one or more of the four goals for fiscal year
2024 are not met.
``(bb) $3,906,000 if the four goals for fiscal year 2024
are met.
``(C) Performance calculation.--For purposes of this
paragraph, performance of the goals listed in subparagraph
(D) shall be determined as specified in the letters described
in section 201(b) of the Medical Device User Fee Amendments
of 2022 and based on data available as of the following
dates:
``(i) The performance of the pre-submission written
feedback goal shall be based on data available as of--
``(I) for fiscal year 2023, March 31, 2024;
``(II) for fiscal year 2024, March 31, 2025; and
``(III) for fiscal year 2025, March 31, 2026.
``(ii) The performance of the de novo decision goal, 510(k)
decision goal, 510(k) shared outcome total time to decision
goal, PMA decision goal, and PMA shared outcome total time to
decision goal shall be based on data available as of--
``(I) for fiscal year 2023, March 31, 2025; and
``(II) for fiscal year 2024, March 31, 2026.
``(D) Goals defined.--For purposes of this paragraph, the
terms `pre-submission written feedback goal', `de novo
decision goal', `510(k) decision goal', `510(k) shared
outcome total time to decision goal', `PMA decision goal',
and `PMA shared outcome total time to decision goal' refer to
the goals identified by the same names in the letters
described in section 201(b) of the Medical Device User Fee
Amendments of 2022.
``(5) Hiring adjustment.--
``(A) In general.--For each of fiscal years 2025 through
2027, after the adjustments under paragraphs (2), (3), and
(4), if applicable, if the number of hires to support the
process for the review of device applications falls below the
thresholds specified in subparagraph (B) for the applicable
fiscal years, the base establishment registration fee amounts
shall be decreased as the Secretary determines necessary to
achieve a reduction in total fee collections equal to the
hiring adjustment amount under subparagraph (C).
``(B) Thresholds.--The thresholds specified in this
subparagraph are as follows:
``(i) For fiscal year 2025, the threshold is 123 hires for
fiscal year 2023.
[[Page H5302]]
``(ii) For fiscal year 2026, the threshold is 38 hires for
fiscal year 2024.
``(iii) For fiscal year 2027, the threshold is--
``(I) 22 hires for fiscal year 2025 if the base
establishment registration fees are not increased by the
amount determined under paragraph (4)(A)(i); or
``(II) 75 hires for fiscal year 2025 if such fees are so
increased.
``(C) Hiring adjustment amount.--The hiring adjustment
amount for fiscal year 2025 and each subsequent fiscal year
is the product of--
``(i) the number of hires by which the hiring goal
specified in subparagraph (D) for the fiscal year before the
prior fiscal year was not met;
``(ii) $72,877; and
``(iii) the applicable inflation adjustment under paragraph
(2)(B) for the fiscal year for which the hiring goal was not
met.
``(D) Hiring goals.--The hiring goals for each of fiscal
years 2023 through 2025 are as follows:
``(i) For fiscal year 2023, 144 hires.
``(ii) For fiscal year 2024, 42 hires.
``(iii) For fiscal year 2025:
``(I) 24 hires if the base establishment registration fees
are not increased by the amount determined under paragraph
(4)(A)(i).
``(II) 83 hires if the base establishment registration fees
are increased by the amount determined under paragraph
(4)(A)(i).
``(E) Number of hires.--For purposes of this paragraph, the
number of hires shall be determined by the Secretary as set
forth in the letters described in section 201(b) of the
Medical Device User Fee Amendments of 2022.
``(6) Operating reserve adjustment.--
``(A) In general.--For each of fiscal years 2023 through
2027, after the adjustments under paragraphs (2), (3), (4),
and (5), if applicable, if the Secretary has operating
reserves of carryover user fees for the process for the
review of device applications in excess of the designated
amount in subparagraph (B), the Secretary shall decrease the
base establishment registration fee amounts to provide for
not more than such designated amount of operating reserves.
``(B) Designated amount.--Subject to subparagraph (C), for
each fiscal year, the designated amount in this subparagraph
is equal to the sum of--
``(i) 13 weeks of operating reserves of carryover user
fees; and
``(ii) 1 month of operating reserves maintained pursuant to
paragraph (8).
``(C) Excluded amount.--For the period of fiscal years 2023
through 2026, a total amount equal to $118,000,000 shall not
be considered part of the designated amount under
subparagraph (B) and shall not be subject to the decrease
under subparagraph (A).''.
(d) Small Businesses.--Section 738 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j) is amended in each of
subsections (d)(2)(B)(iii) and (e)(2)(B)(iii) by inserting
``, if extant,'' after ``national taxing authority''.
(e) Conditions.--Section 738(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j(g)) is amended--
(1) in paragraph (1)(A), by striking ``$320,825,000'' and
inserting ``$398,566,000''; and
(2) in paragraph (2), by inserting ``de novo classification
requests,'' after ``class III device,''.
(f) Crediting and Availability of Fees.--Section 738(h)(3)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j(h)(3)) is amended to read as follows:
``(3) Authorization of appropriations.--
``(A) In general.--For each of fiscal years 2023 through
2027, there is authorized to be appropriated for fees under
this section an amount equal to the revenue amount determined
under subparagraph (B), less the amount of reductions
determined under subparagraph (C).
``(B) Revenue amount.--For purposes of this paragraph, the
revenue amount for each fiscal year is the sum of--
``(i) the total revenue amount under subsection (b)(3) for
the fiscal year, as adjusted under paragraphs (2) and (3) of
subsection (c); and
``(ii) the performance improvement adjustment amount for
the fiscal year under subsection (c)(4), if applicable.
``(C) Reductions.--For purposes of this paragraph, the
amount of reductions for each fiscal year is the sum of--
``(i) the hiring adjustment amount for the fiscal year
under subsection (c)(5), if applicable; and
``(ii) the operating reserve adjustment amount for the
fiscal year under subsection (c)(6), if applicable.''.
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Reports.--Section 738A(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is
amended--
(1) by striking ``fiscal year 2018'' each place it appears
and inserting ``fiscal year 2023'';
(2) by striking ``Medical Device User Fee Amendments of
2017'' each place it appears and inserting ``Medical Device
User Fee Amendments of 2022'';
(3) in paragraph (1)--
(A) in subparagraph (A), by redesignating the second clause
(iv) (relating to analysis) as clause (v); and
(B) in subparagraph (A)(iv), by striking ``fiscal year
2020'' and inserting ``fiscal year 2023''; and
(4) in paragraph (4), by striking ``2018 through 2022'' and
inserting ``2023 through 2027''.
(b) Reauthorization.--Section 738A(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
(1) in paragraph (1), by striking ``2022'' and inserting
``2027''; and
(2) in paragraph (5), by striking ``2022'' and inserting
``2027''.
SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.
Section 514(d) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360d(d)) is amended to read as follows:
``(d) Accreditation Scheme for Conformity Assessment.--
``(1) In general.--The Secretary shall establish a program
under which--
``(A) testing laboratories meeting criteria specified in
guidance by the Secretary may be accredited by accreditation
bodies meeting criteria specified in guidance by the
Secretary, to conduct testing to support the assessment of
the conformity of a device to certain standards recognized
under this section; and
``(B) subject to paragraph (2), results from tests
conducted to support the assessment of conformity of devices
as described in subparagraph (A) conducted by testing
laboratories accredited pursuant to this subsection shall be
accepted by the Secretary for purposes of demonstrating such
conformity unless the Secretary finds that certain results of
such tests should not be so accepted.
``(2) Secretarial review of accredited laboratory
results.--The Secretary may--
``(A) review the results of tests conducted by testing
laboratories accredited pursuant to this subsection,
including by conducting periodic audits of such results or of
the processes of accredited bodies or testing laboratories;
``(B) following such review, take additional measures under
this Act, as the Secretary determines appropriate, such as--
``(i) suspension or withdrawal of accreditation of a
testing laboratory or recognition of an accreditation body
under paragraph (1)(A); or
``(ii) requesting additional information with respect to a
device; and
``(C) if the Secretary becomes aware of information
materially bearing on the safety or effectiveness of a device
for which an assessment of conformity was supported by
testing conducted by a testing laboratory accredited under
this subsection, take such additional measures under this
Act, as the Secretary determines appropriate, such as--
``(i) suspension or withdrawal of accreditation of a
testing laboratory or recognition of an accreditation body
under paragraph (1)(A); or
``(ii) requesting additional information with regard to
such device.
``(3) Implementation and reporting.--
``(A) Pilot program transition.--After September 30, 2023,
the pilot program previously initiated under this subsection,
as in effect prior to the date of enactment of the Medical
Device User Fee Amendments of 2022, shall be considered to be
completed, and the Secretary may continue operating a program
consistent with this subsection.
``(B) Report.--The Secretary shall make available on the
internet website of the Food and Drug Administration an
annual report on the progress of the pilot program under this
subsection.''.
SEC. 206. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM.
Section 523(c) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360m(c)) is amended by striking ``2022'' and
inserting ``2027''.
SEC. 207. SUNSET DATES.
(a) Authorization.--Sections 737 and 738 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) shall
cease to be effective October 1, 2027.
(b) Reporting Requirements.--Section 738A (21 U.S.C. 379j-
1) of the Federal Food, Drug, and Cosmetic Act (regarding
reauthorization and reporting requirements) shall cease to be
effective January 31, 2028.
(c) Previous Sunset Provisions.--Effective October 1, 2022,
subsections (a) and (b) of section 210 of the FDA
Reauthorization Act of 2017 (Public Law 115-52) are repealed.
SEC. 208. EFFECTIVE DATE.
The amendments made by this title shall take effect on
October 1, 2022, or the date of the enactment of this Act,
whichever is later, except that fees under part 3 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379i et seq.) shall be assessed for
all submissions listed in section 738(a)(2)(A) of such Act
received on or after October 1, 2022, regardless of the date
of the enactment of this Act.
SEC. 209. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 3
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the
day before the date of the enactment of this title, shall
continue to be in effect with respect to the submissions
listed in section 738(a)(2)(A) of such Act (as defined in
such part as of such day) that on or after October 1, 2017,
but before October 1, 2022, were received by the Food and
Drug Administration with respect to assessing and collecting
any fee required by such part for a fiscal year prior to
fiscal year 2023.
[[Page H5303]]
TITLE III--FEES RELATING TO GENERIC DRUGS
SEC. 301. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Generic
Drug User Fee Amendments of 2022''.
(b) Finding.--The Congress finds that the fees authorized
by the amendments made by this title will be dedicated to
human generic drug activities, as set forth in the goals
identified for purposes of part 7 of subchapter C of chapter
VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j-41 et seq.), in the letters from the Secretary of Health
and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Chairman of the Committee on Energy and Commerce of the House
of Representatives, as set forth in the Congressional Record.
SEC. 302. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG
FEES.
(a) Types of Fees.--Section 744B(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``fiscal year 2018'' and inserting ``fiscal year 2023'';
(2) in paragraph (2)(C), by striking ``2018 through 2022''
and inserting ``2023 through 2027'';
(3) in paragraph (3)(B), by striking ``2018 through 2022''
and inserting ``2023 through 2027'';
(4) in paragraph (4)(D), by striking ``2018 through 2022''
and inserting ``2023 through 2027''; and
(5) in paragraph (5)(D), by striking ``2018 through 2022''
and inserting ``2023 through 2027''.
(b) Fee Revenue Amounts.--Section 744B(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(b)) is
amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) in the heading, by striking ``2018'' and inserting
``2023'';
(ii) by striking ``2018'' and inserting ``2023''; and
(iii) by striking ``$493,600,000'' and inserting
``$582,500,000''; and
(B) by amending subparagraph (B) to read as follows:
``(B) Fiscal years 2024 through 2027.--
``(i) In general.--For each of the fiscal years 2024
through 2027, fees under paragraphs (2) through (5) of
subsection (a) shall be established to generate a total
estimated revenue amount under such subsection that is equal
to the base revenue amount for the fiscal year under clause
(ii), as adjusted pursuant to subsection (c).
``(ii) Base revenue amount.--The base revenue amount for a
fiscal year referred to in clause (i) is equal to the total
revenue amount established under this paragraph for the
previous fiscal year, not including any adjustments made for
such previous fiscal year under subsection (c)(3).''; and
(2) in paragraph (2)--
(A) in subparagraph (C), by striking ``one-third the
amount'' and inserting ``twenty-four percent'';
(B) in subparagraph (D), by striking ``Seven percent'' and
inserting ``Six percent''; and
(C) in subparagraph (E)(i), by striking ``Thirty-five
percent'' and inserting ``Thirty-six percent''.
(c) Adjustments.--Section 744B(c) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A)--
(i) by striking ``2019'' and inserting ``2024''; and
(ii) by striking ``to equal the product of the total
revenues established in such notice for the prior fiscal year
multiplied'' and inserting ``to equal the base revenue amount
for the fiscal year (as specified in subsection (b)(1)(B))
multiplied''; and
(B) in subparagraph (C), by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
Arlington-Alexandria, DC-VA-MD-WV''; and
(2) by striking paragraph (2) and inserting the following:
``(2) Capacity planning adjustment.--
``(A) In general.--Beginning with fiscal year 2024, the
Secretary shall, in addition to the adjustment under
paragraph (1), further increase the fee revenue and fees
under this section for a fiscal year, in accordance with this
paragraph, to reflect changes in the resource capacity needs
of the Secretary for human generic drug activities.
``(B) Capacity planning methodology.--The Secretary shall
establish a capacity planning methodology for purposes of
this paragraph, which shall--
``(i) be derived from the methodology and recommendations
made in the report titled `Independent Evaluation of the
GDUFA Resource Capacity Planning Adjustment Methodology:
Evaluation and Recommendations' announced in the Federal
Register on August 3, 2020;
``(ii) incorporate approaches and attributes determined
appropriate by the Secretary, including approaches and
attributes made in such report, except that in incorporating
such approaches and attributes the workload categories used
in forecasting resources shall only be the workload
categories specified in section VIII.B.2.e. of the letters
described in section 301(b) of the Generic Drug User Fee
Amendments of 2022; and
``(iii) be effective beginning with fiscal year 2024.
``(C) Limitations.--
``(i) In general.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue for a
fiscal year that is less than the sum of the amounts under
subsection (b)(1)(B)(ii) (the base revenue amount for the
fiscal year) and paragraph (1) (the dollar amount of the
inflation adjustment for the fiscal year).
``(ii) Percentage limitation.--An adjustment under this
paragraph shall not exceed three percent of the sum described
in clause (i) for the fiscal year, except that such
limitation shall be four percent if--
``(I) for purposes of a fiscal year 2024 adjustment, the
Secretary determines that during the period from April 1,
2021, through March 31, 2023--
``(aa) the total number of abbreviated new drug
applications submitted was greater than or equal to 2,000; or
``(bb) thirty-five percent or more of abbreviated new drug
applications submitted related to complex products (as that
term is defined in section XI of the letters described in
section 301(b) of the Generic Drug User Fee Amendments of
2022);
``(II) for purposes of a fiscal year 2025 adjustment, the
Secretary determines that during the period from April 1,
2022, through March 31, 2024--
``(aa) the total number of abbreviated new drug
applications submitted was greater than or equal to 2,300; or
``(bb) thirty-five percent or more of abbreviated new drug
applications submitted related to complex products (as so
defined);
``(III) for purposes of a fiscal year 2026 adjustment, the
Secretary determines that during the period from April 1,
2023, through March 31, 2025--
``(aa) the total number of abbreviated new drug
applications submitted was greater than or equal to 2,300; or
``(bb) thirty-five percent or more of abbreviated new drug
applications submitted related to complex products (as so
defined); and
``(IV) for purposes of a fiscal year 2027 adjustment, the
Secretary determines that during the period from April 1,
2024, through March 31, 2026--
``(aa) the total number of abbreviated new drug
applications submitted was greater than or equal to 2,300; or
``(bb) thirty-five percent or more of abbreviated new drug
applications submitted related to complex products (as so
defined).
``(D) Publication in federal register.--The Secretary shall
publish in the Federal Register notice referred to in
subsection (a) the fee revenue and fees resulting from the
adjustment and the methodology under this paragraph.
``(3) Operating reserve adjustment.--
``(A) In general.--For fiscal year 2024 and each subsequent
fiscal year, the Secretary may, in addition to adjustments
under paragraphs (1) and (2), further increase the fee
revenue and fees under this section for such fiscal year if
such an adjustment is necessary to provide operating reserves
of carryover user fees for human generic drug activities for
not more than the number of weeks specified in subparagraph
(B) with respect to that fiscal year.
``(B) Number of weeks.--The number of weeks specified in
this subparagraph is--
``(i) 8 weeks for fiscal year 2024;
``(ii) 9 weeks for fiscal year 2025; and
``(iii) 10 weeks for each of fiscal year 2026 and 2027.
``(C) Decrease.--If the Secretary has carryover balances
for human generic drug activities in excess of 12 weeks of
the operating reserves referred to in subparagraph (A), the
Secretary shall decrease the fee revenue and fees referred to
in such subparagraph to provide for not more than 12 weeks of
such operating reserves.
``(D) Rationale for adjustment.--If an adjustment under
this paragraph is made, the rationale for the amount of the
increase or decrease (as applicable) in fee revenue and fees
shall be contained in the annual Federal Register notice
under subsection (a) publishing the fee revenue and fees for
the fiscal year involved.''.
(d) Annual Fee Setting.--Section 744B(d)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(d)(1)) is
amended--
(1) in the paragraph heading, by striking ``2018 through
2022'' and inserting ``2023 through 2027''; and
(2) by striking ``more than 60 days before the first day of
each of fiscal years 2018 through 2022'' and inserting
``later than 60 days before the first day of each of fiscal
years 2023 through 2027''.
(e) Crediting and Availability of Fees.--Section 744B(i)(3)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
42(i)(3)) is amended by striking ``fiscal years 2018 through
2022'' and inserting ``fiscal years 2023 through 2027''.
(f) Effect of Failure to Pay Fees.--The heading of
paragraph (3) of section 744B(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-42(g)) is amended by
striking ``and prior approval supplement fee''.
SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744C of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-43) is amended--
(1) in subsection (a)(1), by striking ``Beginning with
fiscal year 2018, not'' and inserting ``Not'';
(2) by striking ``Generic Drug User Fee Amendments of
2017'' each place it appears
[[Page H5304]]
and inserting ``Generic Drug User Fee Amendments of 2022'';
(3) in subsection (a)(2), by striking ``Not later than 30
calendar days after the end of the second quarter of fiscal
year 2018, and not later than 30 calendar days after the end
of each quarter of each fiscal year thereafter'' and
inserting ``Not later than 30 calendar days after the end of
each quarter of each fiscal year for which fees are collected
under this part'';
(4) in subsection (a)(3), by striking ``Beginning with
fiscal year 2020, the'' and inserting ``The'';
(5) in subsection (b), by striking ``Beginning with fiscal
year 2018, not'' and inserting ``Not'';
(6) in subsection (c), by striking ``Beginning with fiscal
year 2018, for'' and inserting ``For''; and
(7) in subsection (f)--
(A) in paragraph (1), in the matter preceding subparagraph
(A), by striking ``fiscal year 2022'' and inserting ``fiscal
year 2027''; and
(B) in paragraph (5), by striking ``January 15, 2022'' and
inserting ``January 15, 2027''.
SEC. 304. SUNSET DATES.
(a) Authorization.--Sections 744A and 744B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42)
shall cease to be effective October 1, 2027.
(b) Reporting Requirements.--Section 744C of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease
to be effective January 31, 2028.
(c) Previous Sunset Provision.--Effective October 1, 2022,
subsections (a) and (b) of section 305 of the FDA
Reauthorization Act of 2017 (Public Law 115-52) are repealed.
SEC. 305. EFFECTIVE DATE.
The amendments made by this title shall take effect on
October 1, 2022, or the date of the enactment of this Act,
whichever is later, except that fees under part 7 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-41 et seq.) shall be assessed
for all abbreviated new drug applications received on or
after October 1, 2022, regardless of the date of the
enactment of this Act.
SEC. 306. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 7
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-41 et seq.), as in effect on the
day before the date of the enactment of this title, shall
continue to be in effect with respect to abbreviated new drug
applications (as defined in such part as of such day) that
were received by the Food and Drug Administration within the
meaning of section 505(j)(5)(A) of such Act (21 U.S.C.
355(j)(5)(A)), prior approval supplements that were
submitted, and drug master files for Type II active
pharmaceutical ingredients that were first referenced on or
after October 1, 2017, but before October 1, 2022, with
respect to assessing and collecting any fee required by such
part for a fiscal year prior to fiscal year 2023.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
SEC. 401. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the
``Biosimilar User Fee Amendments of 2022''.
(b) Finding.--The Congress finds that the fees authorized
by the amendments made by this title will be dedicated to
expediting the process for the review of biosimilar
biological product applications, including postmarket safety
activities, as set forth in the goals identified for purposes
of part 8 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-51 et seq.), in the
letters from the Secretary of Health and Human Services to
the Chairman of the Committee on Health, Education, Labor,
and Pensions of the Senate and the Chairman of the Committee
on Energy and Commerce of the House of Representatives, as
set forth in the Congressional Record.
SEC. 402. DEFINITIONS.
(a) Adjustment Factor.--Section 744G(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(1)) is
amended to read as follows:
``(1) The term `adjustment factor' applicable to a fiscal
year is the Consumer Price Index for urban consumers
(Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally
Adjusted; All items; Annual Index) for September of the
preceding fiscal year divided by such Index for September
2011.''.
(b) Biosimilar Biological Product Application.--Section
744G(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-51(4)(B)(iii)) is amended--
(1) by striking subclause (II) (relating to an allergenic
extract product); and
(2) by redesignating subclauses (III) and (IV) as
subclauses (II) and (III), respectively.
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.
(a) Types of Fees.--
(1) In general.--The matter preceding paragraph (1) in
section 744H(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-52(a)) is amended by striking ``fiscal year
2018'' and inserting ``fiscal year 2023''.
(2) Initial biosimilar biological product development
fee.--Clauses (iv)(I) and (v)(II) of section 744H(a)(1)(A) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
52(a)(1)(A)) are each amended by striking ``5 days'' and
inserting ``7 days''.
(3) Annual biosimilar biological product development fee.--
Section 744H(a)(1)(B) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379j-52(a)(1)(B)) is amended--
(A) in clause (i), by inserting before the period at the
end the following: ``, except where such product (including,
where applicable, ownership of the relevant investigational
new drug application) is transferred to a licensee, assignee,
or successor of such person, and written notice of such
transfer is provided to the Secretary, in which case such
licensee, assignee, or successor shall pay the annual
biosimilar biological product development fee'';
(B) in clause (iii)--
(i) in subclause (I), by striking ``or'' at the end;
(ii) in subclause (II), by striking the period at the end
and inserting ``; or''; and
(iii) by adding at the end the following:
``(III) been administratively removed from the biosimilar
biological product development program for the product under
subparagraph (E)(v).''; and
(C) in clause (iv), by striking ``is accepted for filing on
or after October 1 of such fiscal year'' and inserting ``is
subsequently accepted for filing''.
(4) Reactivation fee.--Section 744H(a)(1)(D) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)(1)(D)) is
amended to read as follows:
``(D) Reactivation fee.--
``(i) In general.--A person that has discontinued
participation in the biosimilar biological product
development program for a product under subparagraph (C), or
who has been administratively removed from the biosimilar
biological product development program for a product under
subparagraph (E)(v), shall, if the person seeks to resume
participation in such program, pay all annual biosimilar
biological product development fees previously assessed for
such product and still owed and a fee (referred to in this
section as `reactivation fee') by the earlier of the
following:
``(I) Not later than 7 days after the Secretary grants a
request by such person for a biosimilar biological product
development meeting for the product (after the date on which
such participation was discontinued or the date of
administrative removal, as applicable).
``(II) Upon the date of submission (after the date on which
such participation was discontinued or the date of
administrative removal, as applicable) by such person of an
investigational new drug application describing an
investigation that the Secretary determines is intended to
support a biosimilar biological product application for that
product.
``(ii) Application of annual fee.--A person that pays a
reactivation fee for a product shall pay for such product,
beginning in the next fiscal year, the annual biosimilar
biological product development fee under subparagraph (B),
except where such product (including, where applicable,
ownership of the relevant investigational new drug
application) is transferred to a licensee, assignee, or
successor of such person, and written notice of such transfer
is provided to the Secretary, in which case such licensee,
assignee, or successor shall pay the annual biosimilar
biological product development fee.''.
(5) Effect of failure to pay fees.--Section 744H(a)(1)(E)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
52(a)(1)(E)) is amended by adding at the end the following:
``(v) Administrative removal from the biosimilar biological
product development program.--If a person has failed to pay
an annual biosimilar biological product development fee for a
product as required under subparagraph (B) for a period of
two consecutive fiscal years, the Secretary may
administratively remove such person from the biosimilar
biological product development program for the product. At
least 30 days prior to administratively removing a person
from the biosimilar biological product development program
for a product under this clause, the Secretary shall provide
written notice to such person of the intended administrative
removal.''.
(6) Biosimilar biological product application fee.--Section
744H(a)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(a)(2)(D)) is amended by inserting after ``or
was withdrawn'' the following: ``prior to approval''.
(7) Biosimilar biological product program fee.--Section
744H(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52(a)(3)) is amended--
(A) in subparagraph (A)--
(i) in clause (i), by striking ``and'' at the end;
(ii) by redesignating clause (ii) as clause (iii); and
(iii) by inserting after clause (i) the following:
``(ii) may be dispensed only under prescription pursuant to
section 503(b); and''; and
(B) by adding at the end the following:
``(E) Movement to discontinued list.--
``(i) Date of inclusion.--If a written request to place a
product on the list referenced in subparagraph (A) of
discontinued biosimilar biological products is submitted to
the Secretary on behalf of an applicant, and the request
identifies the date the product is withdrawn from sale, then
for purposes of assessing the biosimilar biological product
program fee, the Secretary shall consider such product to
have been included on such list on the later of--
``(I) the date such request was received; or
[[Page H5305]]
``(II) if the product will be withdrawn from sale on a
future date, such future date when the product is withdrawn
from sale.
``(ii) Treatment as withdrawn from sale.--For purposes of
clause (i), a product shall be considered withdrawn from sale
once the applicant has ceased its own distribution of the
product, whether or not the applicant has ordered recall of
all previously distributed lots of the product, except that a
routine, temporary interruption in supply shall not render a
product withdrawn from sale.
``(iii) Special rule.--If a biosimilar biological product
that is identified in a biosimilar biological product
application approved as of October 1 of a fiscal year
appears, as of October 1 of such fiscal year, on the list
referenced in subparagraph (A) of discontinued biosimilar
biological products, and on any subsequent day during such
fiscal year the biosimilar biological product does not appear
on such list, then except as provided in subparagraph (D),
each person who is named as the applicant in a biosimilar
biological product application with respect to such product
shall pay the annual biosimilar biological product program
fee established for a fiscal year under subsection (c)(5) for
such biosimilar biological product. Notwithstanding
subparagraph (B), such fee shall be due on the last business
day of such fiscal year and shall be paid only once for each
such product for each fiscal year.''.
(8) Biosimilar biological product fee.--Section 744H(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
52(a)) is amended by striking paragraph (4).
(c) Fee Revenue Amounts.--Subsection (b) of section 744H of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52)
is amended--
(1) by striking paragraph (1);
(2) by redesignating paragraphs (2) through (4) as
paragraphs (1) through (3), respectively;
(3) by amending paragraph (1) (as so redesignated) to read
as follows:
``(1) In general.--For each of the fiscal years 2023
through 2027, fees under subsection (a) shall, except as
provided in subsection (c), be established to generate a
total revenue amount equal to the sum of--
``(A) the annual base revenue for the fiscal year (as
determined under paragraph (3));
``(B) the dollar amount equal to the inflation adjustment
for the fiscal year (as determined under subsection (c)(1));
``(C) the dollar amount equal to the strategic hiring and
retention adjustment (as determined under subsection (c)(2));
``(D) the dollar amount equal to the capacity planning
adjustment for the fiscal year (as determined under
subsection (c)(3));
``(E) the dollar amount equal to the operating reserve
adjustment for the fiscal year, if applicable (as determined
under subsection (c)(4));
``(F) for fiscal year 2023 an additional amount of
$4,428,886; and
``(G) for fiscal year 2024 an additional amount of
$320,569.'';
(4) in paragraph (2) (as so redesignated)--
(A) in the paragraph heading, by striking ``; limitations
on fee amounts'';
(B) by striking subparagraph (B); and
(C) by redesignating subparagraphs (C) and (D) as
subparagraphs (B) and (C), respectively; and
(5) by amending paragraph (3) (as so redesignated) to read
as follows:
``(3) Annual base revenue.--For purposes of paragraph (1),
the dollar amount of the annual base revenue for a fiscal
year shall be--
``(A) for fiscal year 2023, $43,376,922; and
``(B) for fiscal years 2024 through 2027, the dollar amount
of the total revenue amount established under paragraph (1)
for the previous fiscal year, excluding any adjustments to
such revenue amount under subsection (c)(4).''.
(d) Adjustments; Annual Fee Setting.--Section 744H(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
52(c)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by striking
``subsection (b)(2)(B)'' and inserting ``subsection
(b)(1)(B)''; and
(ii) in clause (i), by striking ``subsection (b)'' and
inserting ``subsection (b)(1)(A)''; and
(B) in subparagraph (B)(ii), by striking ``Washington-
Baltimore, DC-MD-VA-WV'' and inserting ``Washington-
Arlington-Alexandria, DC-VA-MD-WV'';
(2) by striking paragraphs (2) through (4) and inserting
the following:
``(2) Strategic hiring and retention adjustment.--For each
fiscal year, after the annual base revenue under subsection
(b)(1)(A) is adjusted for inflation in accordance with
paragraph (1), the Secretary shall further increase the fee
revenue and fees by $150,000.
``(3) Capacity planning adjustment.--
``(A) In general.--For each fiscal year, the Secretary
shall, in addition to the adjustments under paragraphs (1)
and (2), further adjust the fee revenue and fees under this
section for a fiscal year to reflect changes in the resource
capacity needs of the Secretary for the process for the
review of biosimilar biological product applications.
``(B) Methodology.--For purposes of this paragraph, the
Secretary shall employ the capacity planning methodology
utilized by the Secretary in setting fees for fiscal year
2021, as described in the notice titled `Biosimilar User Fee
Rates for Fiscal Year 2021' published in the Federal Register
on August 4, 2020 (85 Fed. Reg. 47220). The workload
categories used in applying such methodology in forecasting
shall include only the activities described in that notice
and, as feasible, additional activities that are also
directly related to the direct review of biosimilar
biological product applications and supplements, including
additional formal meeting types, the direct review of
postmarketing commitments and requirements, the direct review
of risk evaluation and mitigation strategies, and the direct
review of annual reports for approved biosimilar biological
products. Subject to the exceptions in the preceding
sentence, the Secretary shall not include as workload
categories in applying such methodology in forecasting any
non-core review activities, including those activities that
the Secretary referenced for potential future use in such
notice but did not utilize in setting fees for fiscal year
2021.
``(C) Limitations.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue for a
fiscal year that is less than the sum of the amounts under
subsections (b)(1)(A) (the annual base revenue for the fiscal
year), (b)(1)(B) (the dollar amount of the inflation
adjustment for the fiscal year), and (b)(1)(C) (the dollar
amount of the strategic hiring and retention adjustment).
``(D) Publication in federal register.--The Secretary shall
publish in the Federal Register notice under paragraph (5)
the fee revenue and fees resulting from the adjustment and
the methodologies under this paragraph.
``(4) Operating reserve adjustment.--
``(A) Increase.--For fiscal year 2023 and subsequent fiscal
years, the Secretary shall, in addition to adjustments under
paragraphs (1), (2), and (3), further increase the fee
revenue and fees if such an adjustment is necessary to
provide for at least 10 weeks of operating reserves of
carryover user fees for the process for the review of
biosimilar biological product applications.
``(B) Decrease.--
``(i) Fiscal year 2023.--For fiscal year 2023, if the
Secretary has carryover balances for such process in excess
of 33 weeks of such operating reserves, the Secretary shall
decrease such fee revenue and fees to provide for not more
than 33 weeks of such operating reserves.
``(ii) Fiscal year 2024.--For fiscal year 2024, if the
Secretary has carryover balances for such process in excess
of 27 weeks of such operating reserves, the Secretary shall
decrease such fee revenue and fees to provide for not more
than 27 weeks of such operating reserves.
``(iii) Fiscal year 2025 and subsequent fiscal years.--For
fiscal year 2025 and subsequent fiscal years, if the
Secretary has carryover balances for such process in excess
of 21 weeks of such operating reserves, the Secretary shall
decrease such fee revenue and fees to provide for not more
than 21 weeks of such operating reserves.
``(C) Federal register notice.--If an adjustment under
subparagraph (A) or (B) is made, the rationale for the amount
of the increase or decrease in fee revenue and fees shall be
contained in the annual Federal Register notice under
paragraph (5)(B) establishing fee revenue and fees for the
fiscal year involved.''; and
(3) in paragraph (5), in the matter preceding subparagraph
(A), by striking ``2018'' and inserting ``2023''.
(e) Crediting and Availability of Fees.--Subsection (f)(3)
of section 744H of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-52(f)(3)) is amended by striking ``2018
through 2022'' and inserting ``2023 through 2027''.
(f) Written Requests for Waivers and Returns; Disputes
Concerning Fees.--Section 744H(h) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j-52(h)) is amended to read as
follows:
``(h) Written Requests for Waivers and Returns; Disputes
Concerning Fees.--To qualify for consideration for a waiver
under subsection (d), or for the return of any fee paid under
this section, including if the fee is claimed to have been
paid in error, a person shall submit to the Secretary a
written request justifying such waiver or return and, except
as otherwise specified in this section, such written request
shall be submitted to the Secretary not later than 180 days
after such fee is due. A request submitted under this
paragraph shall include any legal authorities under which the
request is made.''.
SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744I of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-53) is amended--
(1) in subsection (a)(1), by striking ``Beginning with
fiscal year 2018, not'' and inserting ``Not'';
(2) by striking ``Biosimilar User Fee Amendments of 2017''
each place it appears and inserting ``Biosimilar User Fee
Amendments of 2022'';
(3) in subsection (a)(2), by striking ``Beginning with
fiscal year 2018, the'' and inserting ``The'';
(4) in subsection (a)(3)(A), by striking ``Not later than
30 calendar days after the end of the second quarter of
fiscal year 2018, and not later than 30 calendar days after
the end of each quarter of each fiscal year thereafter'' and
inserting ``Not later than 30 calendar days after the end of
each quarter of each fiscal year for which fees are collected
under this part'';
(5) in subsection (b), by striking ``Not later than 120
days after the end of fiscal year 2018 and each subsequent
fiscal year for which
[[Page H5306]]
fees are collected under this part'' and inserting ``Not
later than 120 days after the end of each fiscal year for
which fees are collected under this part'';
(6) in subsection (c), by striking ``Beginning with fiscal
year 2018, and for'' and inserting ``For''; and
(7) in subsection (f)--
(A) in paragraph (1), in the matter preceding subparagraph
(A), by striking ``fiscal year 2022'' and inserting ``fiscal
year 2027''; and
(B) in paragraph (3), by striking ``January 15, 2022'' and
inserting ``January 15, 2027''.
SEC. 405. SUNSET DATES.
(a) Authorization.--Sections 744G and 744H of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51, 379j-52)
shall cease to be effective October 1, 2027.
(b) Reporting Requirements.--Section 744I of the Federal
Food, Drug, and Cosmetic Act shall cease to be effective
January 31, 2028.
(c) Previous Sunset Provision.--Effective October 1, 2022,
subsections (a) and (b) of section 405 of the FDA
Reauthorization Act of 2017 (Public Law 115-52) are repealed.
SEC. 406. EFFECTIVE DATE.
The amendments made by this title shall take effect on
October 1, 2022, or the date of the enactment of this Act,
whichever is later, except that fees under part 8 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-51 et seq.) shall be assessed
for all biosimilar biological product applications received
on or after October 1, 2022, regardless of the date of the
enactment of this Act.
SEC. 407. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 8
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-51 et seq.), as in effect on the
day before the date of the enactment of this title, shall
continue to be in effect with respect to biosimilar
biological product applications and supplements (as defined
in such part as of such day) that were accepted by the Food
and Drug Administration for filing on or after October 1,
2017, but before October 1, 2022, with respect to assessing
and collecting any fee required by such part for a fiscal
year prior to fiscal year 2023.
TITLE V--IMPROVING DIVERSITY IN CLINICAL STUDIES
SEC. 501. DIVERSITY ACTION PLANS FOR CLINICAL STUDIES.
(a) Drugs.--Section 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)) is amended by adding at the
end the following:
``(5)(A) In order for a new drug that is being studied in a
phase 3 study, as defined in section 312.21(c) of title 21,
Code of Federal Regulations (or successor regulations), or
other pivotal study (other than bioavailability or
bioequivalence studies), to be exempt pursuant to this
subsection, the sponsor of a clinical investigation of such
new drug shall submit to the Secretary a diversity action
plan.
``(B) Such diversity action plan shall include--
``(i) the sponsor's goals for enrollment in such clinical
study;
``(ii) the sponsor's rationale for such goals; and
``(iii) an explanation of how the sponsor intends to meet
such goals.
``(C) The sponsor shall submit such diversity action plan
in the form and manner specified in the guidance required by
section 524B as soon as practicable but no later than when
the sponsor seeks feedback regarding such a phase 3 study or
other pivotal study of the drug.
``(D) The Secretary may waive the requirement in
subparagraph (A) if the Secretary determines that a waiver is
necessary based on what is known about the prevalence of the
disease in terms of the patient population that may use the
new drug.
``(E) No diversity action plan shall be required for a
submission described in section 561.''.
(b) Devices.--Section 520(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j(g)) is amended by adding at the
end the following:
``(9)(A)(i) In order for a device in a clinical study for
which submission of an application for an investigational
device exemption is required to be exempt under this
subsection, the sponsor of such study shall submit to the
Secretary in such application a diversity action plan in the
form and manner specified in the guidance required by section
524B.
``(ii) In order for a device in a clinical study for which
submission of an application for an investigational device
exemption is not required, except for a device being studied
as described in section 812.2(c) of title 21, Code of Federal
Regulations (or successor regulations), to be exempt under
this subsection, the sponsor of such study shall develop and
implement a diversity action plan. Such diversity action plan
shall be submitted to the Secretary in any premarket
notification under section 510(k), request for classification
under section 513(f)(2), or application for premarket
approval under section 515 for such device.
``(B) A diversity action plan under clause (i) or (ii) of
subparagraph (A) shall include--
``(i) the sponsor's goals for enrollment in the clinical
study;
``(ii) the sponsor's rationale for such goals; and
``(iii) an explanation of how the sponsor intends to meet
such goals.
``(C) The Secretary may waive the requirement in
subparagraph (A) or (B) if the Secretary determines that a
waiver is necessary based on what is known about the
prevalence of the disease in terms of the patient population
that may use the device.
``(D) No diversity action plan shall be required for a
submission described in section 561.''.
(c) Guidance.--Subchapter A of chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is
amended by adding at the end the following:
``SEC. 524B. GUIDANCE ON DIVERSITY ACTION PLANS FOR CLINICAL
STUDIES.
``(a) In General.--The Secretary shall issue guidance
relating to--
``(1) the format and content of the diversity action plans
required by sections 505(i)(5) and 520(g)(9) pertaining to
the sponsor's goals for clinical study enrollment,
disaggregated by age group, sex, race, geographic location,
socioeconomic status, and ethnicity, including with respect
to--
``(A) the rationale for the sponsor's enrollment goals,
which may include--
``(i) the estimated prevalence or incidence in the United
States of the disease or condition for which the drug or
device is being developed or investigated, if such estimated
prevalence or incidence is known or can be determined based
on available data;
``(ii) what is known about the disease or condition for
which the drug or device is being developed or investigated;
``(iii) any relevant pharmacokinetic or pharmacogenomic
data;
``(iv) what is known about the patient population for such
disease or condition, including, to the extent data is
available--
``(I) demographic information, including age group, sex,
race, geographic location, socioeconomic status, and
ethnicity;
``(II) non-demographic factors, including co-morbidities
affecting the patient population; and
``(III) potential barriers to enrolling diverse
participants, such as patient population size, geographic
location, and socioeconomic status; and
``(v) any other data or information relevant to selecting
appropriate enrollment goals, disaggregated by demographic
subgroup, such as the inclusion of pregnant and lactating
women;
``(B) an explanation for how the sponsor intends to meet
such goals, including demographic-specific outreach and
enrollment strategies, study-site selection, clinical study
inclusion and exclusion practices, and any diversity training
for study personnel; and
``(C) procedures for the public posting of key information
from the diversity action plan that would be useful to
patients and providers on the sponsor's website, as
appropriate; and
``(2) how sponsors should include in regular reports to the
Secretary--
``(A) the sponsor's progress in meeting the goals referred
to in paragraph (1)(A); and
``(B) if the sponsor does not expect to meet such goals--
``(i) any updates needed to be made to a diversity action
plan referred to in paragraph (1) to help meet such goals;
and
``(ii) the sponsor's reasons for why the sponsor does not
expect to meet such goals.
``(b) Issuance.--The Secretary shall--
``(1) not later than 12 months after the date of enactment
of this section, issue new draft guidance or update existing
draft guidance described in subsection (a); and
``(2) not later than 9 months after closing the comment
period on such draft guidance, finalize such guidance.''.
(d) Applicability.--Sections 505(i)(5) and 520(g)(9) of the
Federal Food, Drug, and Cosmetic Act, as added by subsections
(a) and (b) of this section, apply only with respect to
clinical investigations with respect to which enrollment
commences after the date that is 180 days after the
publication of final guidance under section 524B(b)(2) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection
(c).
SEC. 502. EVALUATION OF THE NEED FOR FDA AUTHORITY TO MANDATE
POSTAPPROVAL STUDIES OR POSTMARKET SURVEILLANCE
DUE TO INSUFFICIENT DEMOGRAPHIC SUBGROUP DATA.
(a) In General.--Not later than 2 years after the date of
publication of final guidance pursuant to section 524B(b)(2)
of the Federal Food, Drug, and Cosmetic Act, as added by
section 501(c) of this Act, the Secretary of Health and Human
Services shall commence an evaluation to assess whether
additions or changes to statutes or regulations are warranted
to ensure that sponsors conduct post-approval studies or
postmarket surveillance where--
(1) premarket studies collected insufficient data for
underrepresented subgroups according to the goals specified
in the diversity action plans of such sponsors; and
(2) the Secretary has requested additional studies be
conducted.
(b) Determination and Reporting.--Not later than 180 days
after the commencement of the evaluation under subsection
(a), the Secretary of Health and Human Services shall submit
a report to the Congress on the outcome of such evaluation,
including any recommendations related to additional needed
authorities.
SEC. 503. PUBLIC WORKSHOPS TO ENHANCE CLINICAL STUDY
DIVERSITY.
(a) In General.--Not later than one year after the date of
enactment of this Act, the
[[Page H5307]]
Secretary of Health and Human Services, in consultation with
drug sponsors, medical device manufacturers, patients, and
other stakeholders, shall convene one or more public
workshops to solicit input from stakeholders on increasing
the enrollment of historically underrepresented populations
in clinical studies and encouraging clinical study
participation that reflects the prevalence of the disease or
condition among demographic subgroups, where appropriate, and
other topics, including--
(1) how and when to collect and present the prevalence or
incidence data on a disease or condition by demographic
subgroup, including possible sources for such data and
methodologies for assessing such data;
(2) considerations for the dissemination, after approval,
of information to the public on clinical study enrollment
demographic data;
(3) the establishment of goals for enrollment in clinical
trials, including the relevance of the estimated prevalence
or incidence, as applicable, in the United States of the
disease or condition for which the drug or device is being
developed; and
(4) approaches to support inclusion of underrepresented
populations and to encourage clinical study participation
that reflects the population expected to use the drug or
device under study, including with respect to--
(A) the establishment of inclusion and exclusion criteria
for certain subgroups, such as pregnant and lactating women
and individuals with disabilities, including intellectual or
developmental disabilities or mental illness;
(B) considerations regarding informed consent with respect
to individuals with intellectual or developmental
disabilities or mental illness, including ethical and
scientific considerations;
(C) the appropriate use of decentralized trials or digital
health tools;
(D) clinical endpoints;
(E) biomarker selection; and
(F) studying analysis.
(b) Public Docket.--The Secretary of Health and Human
Services shall establish a public comment period to receive
written comments related to the topics addressed during each
public workshop convened under this section. The public
comment period shall remain open for 60 days following the
date on which each public workshop is convened.
(c) Report.--Not later than 180 days after the close of the
public comment period for each public workshop convened under
this section, the Secretary of Health and Human Services
shall make available on the public website of the Food and
Drug Administration a report on the topics discussed at such
workshop. The report shall include a summary of, and response
to, recommendations raised in such workshop.
SEC. 504. ANNUAL SUMMARY REPORT ON PROGRESS TO INCREASE
DIVERSITY IN CLINICAL STUDIES.
(a) In General.--Beginning not later than 2 years after the
date of enactment of this Act, and each year thereafter, the
Secretary of Health and Human Services shall submit to the
Congress, and publish on the public website of the Food and
Drug Administration, a report that--
(1) summarizes, in aggregate, the diversity action plans
received pursuant to section 505(i)(5) or 520(g)(9) of the
Federal Food, Drug, and Cosmetic Act, as added by subsection
(a) or (b) of section 501 of this Act; and
(2) contains information on--
(A) for drugs, biological products, and devices approved,
licensed, cleared, or classified under section 505, 515,
510(k), or 513(f)(2) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355; 360e; 360(k); and 360(f)(2)), or section
351(a) of the Public Health Service Act (42 U.S.C. 262(a)),
whether the clinical studies conducted with respect to such
applications met the demographic subgroup enrollment goals
from the diversity action plan submitted for such
applications;
(B) the reasons provided for why enrollment goals from
submitted diversity action plans were not met; and
(C) any postmarket studies of a drug or device in a
demographic subgroup or subgroups required or recommended by
the Secretary based on inadequate premarket clinical study
diversity or based on other reasons where a premarket study
lacked adequate diversity, including the status and
completion date of any such study.
(b) Confidentiality.--Nothing in this section shall be
construed as authorizing the Secretary of Health and Human
Services to disclose any information that is a trade secret
or confidential information subject to section 552(b)(4) of
title 5, United States Code, or section 1905 of title 18,
United States Code.
SEC. 505. PUBLIC MEETING ON CLINICAL STUDY FLEXIBILITIES
INITIATED IN RESPONSE TO COVID-19 PANDEMIC.
(a) In General.--Not later than 180 days after the date on
which the COVID-19 emergency period ends, the Secretary of
Health and Human Services shall convene a public meeting to
discuss the recommendations provided by the Food and Drug
Administration during the COVID-19 emergency period to
mitigate disruption of clinical studies, including
recommendations detailed in the guidance entitled ``Conduct
of Clinical Trials of Medical Products During the COVID-19
Public Health Emergency, Guidance for Industry,
Investigators, and Institutional Review Boards'', as updated
on August 8, 2021, and by any subsequent updates to such
guidance. The Secretary of Health and Human Services shall
invite to such meeting representatives from the
pharmaceutical and medical device industries who sponsored
clinical studies during the COVID-19 emergency period and
organizations representing patients.
(b) Topics.--Not later than 90 days after the date on which
the public meeting under subsection (a) is convened, the
Secretary of Health and Human Services shall make available
on the public website of the Food and Drug Administration a
report on the topics discussed at such meeting. Such topics
shall include discussion of--
(1) the actions drug sponsors took to utilize such
recommendations and the frequency at which such
recommendations were employed;
(2) the characteristics of the sponsors, studies, and
patient populations impacted by such recommendations;
(3) a consideration of how recommendations intended to
mitigate disruption of clinical studies during the COVID-19
emergency period, including any recommendations to consider
decentralized clinical studies when appropriate, may have
affected access to clinical studies for certain patient
populations, especially unrepresented or underrepresented
racial and ethnic minorities; and
(4) recommendations for incorporating certain clinical
study disruption mitigation recommendations into current or
additional guidance to improve clinical study access and
enrollment of diverse patient populations.
(c) COVID-19 Emergency Period Defined.--In this section,
the term ``COVID-19 emergency period'' has the meaning given
the term ``emergency period'' in section 1135(g)(1)(B) of the
Social Security Act (42 U.S.C. 1320b-5(g)(1)(B)).
SEC. 506. DECENTRALIZED CLINICAL STUDIES.
(a) Guidance.--The Secretary of Health and Human Services
shall--
(1) not later than 12 months after the date of enactment of
this Act, issue draft guidance that addresses considerations
for decentralized clinical studies, including considerations
regarding the engagement, enrollment, and retention of a
meaningfully diverse clinical population, with respect to
race, ethnicity, age, sex, and geographic location, when
appropriate; and
(2) not later than 1 year after closing the comment period
on such draft guidance, finalize such guidance.
(b) Content of Guidance.--The guidance under subsection (a)
shall address the following:
(1) Recommendations for how digital health technology or
other remote assessment options, such as telehealth, could
support decentralized clinical studies, including guidance on
considerations for selecting technological platforms and
mediums, data collection and use, data integrity and
security, and communication to study participants through
digital technology.
(2) Recommendations for subject recruitment and retention,
including considerations for sponsors to minimize or reduce
burdens for clinical study participants through the use of
digital health technology, telehealth, local health care
providers and laboratories, or other means.
(3) Recommendations with respect to the evaluation of data
collected within a decentralized clinical study setting.
(c) Definition.--In this section, the term ``decentralized
clinical study'' means a clinical study in which some or all
of the study-related activities occur at a location separate
from the investigator's location.
TITLE VI--GENERIC DRUG COMPETITION
SEC. 601. 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
otherwise) by a person that has submitted or intends to
submit an abbreviated application for a new drug under this
subsection for which the Secretary has specified in
regulation, including in section 314.94(a)(9) of title 21,
Code of Federal Regulations (or any successor regulations),
or recommended in applicable guidance, certain qualitative or
quantitative criteria with respect to an inactive ingredient,
or on the Secretary's own initiative during the review of
such abbreviated application, the Secretary shall inform the
person whether such new drug is qualitatively and
quantitatively the same as the listed drug.
``(ii) Notwithstanding section 301(j), if the Secretary
determines that such new 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 the new 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 new 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
new 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
[[Page H5308]]
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 required by this subparagraph are
disclosures authorized by law including for purposes of
section 1905 of title 18, United States Code.''.
(b) Guidance.--
(1) In general.--Not later than 1 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 new
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 as required by paragraph
(1), 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. 602. ENHANCING ACCESS TO AFFORDABLE MEDICINES.
Section 505(j)(10)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(10)(A)) is amended by striking
clauses (i) through (iii) and inserting the following:
``(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''.
TITLE VII--RESEARCH, DEVELOPMENT, AND SUPPLY CHAIN IMPROVEMENTS
Subtitle A--In General
SEC. 701. ANIMAL TESTING ALTERNATIVES.
Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) is amended--
(1) in subsection (b)(5)(B)(i)(II), by striking ``animal''
and inserting ``nonclinical tests'';
(2) in subsection (i)--
(A) in paragraph (1)(A), by striking ``preclinical tests
(including tests on animals)'' and inserting ``nonclinical
tests''; and
(B) in paragraph (2)(B), by striking ``animal'' and
inserting ``nonclinical tests''; and
(3) after subsection (y), by inserting the following:
``(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.
``(5) Animal tests.''.
SEC. 702. EMERGING TECHNOLOGY PROGRAM.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 201 et seq.) is amended by inserting after section 566
of such Act (21 U.S.C. 360bbb-5) the following:
``SEC. 566A. EMERGING TECHNOLOGY PROGRAM.
``(a) Program Establishment.--
``(1) In general.--The Secretary shall establish a program
to support the adoption of, and improve the development of,
innovative approaches to drug product design and
manufacturing.
``(2) Actions.--In carrying out the program under paragraph
(1), the Secretary may--
``(A) facilitate and increase communication between public
and private entities, consortia, and individuals with respect
to innovative drug product design and manufacturing;
``(B) solicit information regarding, and conduct or support
research on, innovative approaches to drug product design and
manufacturing;
``(C) convene meetings with representatives of industry,
academia, other Federal agencies, international agencies, and
other interested persons, as appropriate;
``(D) convene working groups to support drug product design
and manufacturing research and development;
``(E) support education and training for regulatory staff
and scientists related to innovative approaches to drug
product design and manufacturing;
``(F) advance regulatory science related to the development
and review of innovative approaches to drug product design
and manufacturing;
``(G) convene or participate in working groups to support
the harmonization of international regulatory requirements
related to innovative approaches to drug product design and
manufacturing; and
``(H) award grants or contracts to carry out or support the
program under paragraph (1).
``(3) Grants and contracts.--To seek a grant or contract
under this section, an entity shall submit an application--
``(A) in such form and manner as the Secretary may require;
and
``(B) containing such information as the Secretary may
require, including a description of--
``(i) how the entity will conduct the activities to be
supported through the grant or contract; and
``(ii) how such activities will further research and
development related to, or adoption of, innovative approaches
to drug product design and manufacturing.
``(b) Guidance.--The Secretary shall--
``(1) issue or update guidance to help facilitate the
adoption of, and advance the development of, innovative
approaches to drug product design and manufacturing; and
``(2) include in such guidance descriptions of--
``(A) any regulatory requirements related to the
development or review of technologies related to innovative
approaches to drug product design and manufacturing,
including updates and improvements to such technologies after
product approval; and
``(B) data that can be used to demonstrate the identity,
safety, purity, and potency of drugs manufactured using such
technologies.
``(c) Report to Congress.--Not later than 4 years after the
date of enactment of this section, 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 report containing--
``(1) an annual accounting of the allocation of funds made
available to carry out this section;
``(2) a description of how Food and Drug Administration
staff were utilized to carry out this section and, as
applicable, any challenges or limitations related to
staffing;
``(3) the number of public meetings held or participated in
by the Food and Drug Administration pursuant to this section,
including meetings convened as part of a working group
described in subparagraph (D) or (G) of subsection (a)(2),
and the topics of each such meeting; and
``(4) the number of drug products approved or licensed,
after the date of enactment of this section, using an
innovative approach to drug product design and manufacturing.
``(d) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $20,000,000
for each fiscal year 2023 through 2027.''.
SEC. 703. IMPROVING THE TREATMENT OF RARE DISEASES AND
CONDITIONS.
(a) Report on Orphan Drug Program.--
(1) In general.--Not later than September 30, 2026, 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 report
summarizing the activities of the Food and Drug
Administration related to designating drugs under section 526
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb)
for a rare disease or condition and approving such drugs
under section 505 of such Act (21 U.S.C. 355) or licensing
such drugs under section 351 of the Public Health Service Act
(42 U.S.C. 262), including--
(A) the number of applications for such drugs under section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) or section 351 of the Public Health Service Act (42
U.S.C. 262) received by the Food and Drug Administration, the
number of such applications accepted and rejected for filing,
and the number of such applications pending, approved, and
disapproved by the Food and Drug Administration;
(B) a description of trends in drug approvals for rare
diseases and conditions across review divisions at the Food
and Drug Administration;
(C) the extent to which the Food and Drug Administration is
consulting with external experts pursuant to section
569(a)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-8(a)(2)) on topics pertaining to drugs for a
rare disease or condition, including how and when any such
consultation is occurring; and
(D) the Food and Drug Administration's efforts to promote
best practices in the development of novel treatments for
rare diseases, including--
(i) reviewer training on rare disease-related policies,
methods, and tools; and
(ii) new regulatory science and coordinated support for
patient and stakeholder engagement.
(2) Public availability.--The Secretary shall make the
report under paragraph (1) available to the public, including
by posting the report on the website of the Food and Drug
Administration.
(3) Information disclosure.--Nothing in this subsection
shall be construed to authorize the disclosure of information
that is prohibited from disclosure under section 1905 of
title 18, United States Code, or subject to withholding under
paragraph (4) of section 552(b) of title 5, United States
Code (commonly referred to as the ``Freedom of Information
Act'').
[[Page H5309]]
(b) Study on European Union Safety and Efficacy Reviews of
Drugs for Rare Diseases and Conditions.--
(1) In general.--The Secretary of Health and Human Services
shall enter into a contract with an appropriate entity to
conduct a study on processes for evaluating the safety and
efficacy of drugs for rare diseases or conditions in the
United States and the European Union, including--
(A) flexibilities, authorities, or mechanisms available to
regulators in the United States and the European Union
specific to rare diseases or conditions;
(B) the consideration and use of supplemental data
submitted during review processes in the United States and
the European Union, including data associated with open label
extension studies and expanded access programs specific to
rare diseases or conditions;
(C) an assessment of collaborative efforts between United
States and European Union regulators related to--
(i) product development programs under review;
(ii) policies under development recently issued; and
(iii) scientific information related to product development
or regulation; and
(D) recommendations for how Congress can support
collaborative efforts described in subparagraph (C).
(2) Consultation.--The contract under paragraph (1) shall
provide for consultation with relevant stakeholders,
including--
(A) representatives from the Food and Drug Administration
and the European Medicines Agency;
(B) rare disease or condition patients; and
(C) patient groups that--
(i) represent rare disease or condition patients; and
(ii) have international patient outreach.
(3) Report.--The contract under paragraph (1) shall provide
for, not later than 2 years after the date of entering into
such contract--
(A) the completion of the study under paragraph (1); and
(B) the submission of a report on the results of such study
to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate.
(4) Public availability.--The contract under paragraph (1)
shall provide for the appropriate entity referred to in
paragraph (1) to make the report under paragraph (3)
available to the public, including by posting the report on
the website of the appropriate entity.
(c) Public Meeting.--
(1) In general.--Not later than December 31, 2023, the
Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall convene one or more
public meetings to solicit input from stakeholders regarding
the approaches described in paragraph (2).
(2) Approaches.--The public meeting or meetings under
paragraph (1) shall address approaches to increasing and
improving engagement with rare disease or condition patients,
groups representing such patients, rare disease or condition
experts, and experts on small population studies, in order to
improve the understanding with respect to rare diseases or
conditions of--
(A) patient burden;
(B) treatment options; and
(C) side effects of treatments, including--
(i) comparing the side effects of treatments; and
(ii) understanding the risks of side effects relative to
the health status of the patient and the progression of the
disease or condition.
(3) Public docket.--The Secretary of Health and Human
Services shall establish a public docket to receive written
comments related to the approaches addressed during each
public meeting under paragraph (1). Such public docket shall
remain open for 60 days following the date of each such
public meeting.
(4) Reports.--Not later than 180 days after each public
meeting under paragraph (1), the Commissioner of Food and
Drugs shall develop and publish on the website of the Food
and Drug Administration a report on--
(A) the approaches discussed at the public meeting; and
(B) any related recommendations.
(d) Consultation on the Science of Small Population
Studies.--Section 569(a)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-8(a)(2)) is amended by adding
at the end the following:
``(C) Small population studies.--The external experts on
the list maintained pursuant to subparagraph (A) may include
experts on the science of small population studies.''.
(e) Study on Sufficiency and Use of FDA Mechanisms for
Incorporating the Patient and Clinician Perspective in FDA
Processes Related to Applications Concerning Drugs for Rare
Diseases or Conditions.--
(1) In general.--The Comptroller General of the United
States shall conduct a study on the use of Food and Drug
Administration mechanisms and tools to ensure that patient
and physician perspectives are considered and incorporated
throughout the processes of the Food and Drug
Administration--
(A) for approving or licensing under section 505 of the
Federal Food, Drug, or Cosmetic Act (21 U.S.C. 355) or
section 351 of the Public Health Service Act (42 U.S.C. 262)
a drug designated as a drug for a rare disease or condition
under section 526 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bb); and
(B) in making any determination related to such a drug's
approval, including assessment of the drug's--
(i) safety or effectiveness; or
(ii) postapproval safety monitoring.
(2) Topics.--The study under paragraph (1) shall--
(A) identify and compare the processes that the Food and
Drug Administration has formally put in place and utilized to
gather external expertise (including patients, patient
groups, and physicians) related to applications for rare
diseases or conditions;
(B) examine tools or mechanisms to improve efforts and
initiatives of the Food and Drug Administration to collect
and consider such external expertise with respect to
applications for rare diseases or conditions throughout the
application review and approval or licensure processes,
including within internal benefit-risk assessments, advisory
committee processes, and postapproval safety monitoring; and
(C) examine processes or alternatives to address or resolve
conflicts of interest that impede the Food and Drug
Administration in gaining external expert input on rare
diseases or conditions with a limited set of clinical and
research experts.
(3) Report.--Not later than 2 years after the date of
enactment of this Act, the Comptroller General of the United
States shall--
(A) complete the study under paragraph (1);
(B) submit a report on the results of such study to the
Congress; and
(C) include in such report recommendations, if appropriate,
for changes to the processes and authorities of the Food and
Drug Administration to improve the collection and
consideration of external expert opinions of patients,
patient groups, and physicians with expertise in rare
diseases or conditions.
(f) Definition.--In this section, the term ``rare disease
or condition'' has the meaning given such term in section
526(a)(2) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bb(a)(2)).
SEC. 704. ANTIFUNGAL RESEARCH AND DEVELOPMENT.
(a) Draft Guidance.--Not later than 3 years after the date
of the enactment of this Act, the Secretary of Health and
Human Services, acting through the Commissioner of Food and
Drugs, shall issue draft guidance for industry for the
purposes of assisting entities seeking approval under section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355) or licensure under section 351 of the Public Health
Service Act (42 U.S.C. 262) of antifungal therapies designed
to treat coccidioidomycosis (commonly known as Valley Fever).
(b) Final Guidance.--Not later than 18 months after the
close of the public comment period on the draft guidance
issued pursuant to subsection (a), the Secretary of Health
and Human Services, acting through the Commissioner of Food
and Drugs, shall finalize the draft guidance.
(c) Workshop.--To assist entities developing preventive
vaccines for fungal infections and coccidioidomycosis, the
Secretary of Health and Human Services shall hold a public
workshop.
SEC. 705. ADVANCING QUALIFIED INFECTIOUS DISEASE PRODUCT
INNOVATION.
(a) In General.--Section 505E of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355f) is amended--
(1) in subsection (c)--
(A) in paragraph (2), by striking ``or'' at the end;
(B) in paragraph (3), by striking the period at the end and
inserting ``; or''; and
(C) by adding at the end the following:
``(4) an application pursuant to section 351(a) of the
Public Health Service Act.'';
(2) in subsection (d)(1), by inserting ``of this Act or
section 351(a) of the Public Health Service Act'' after
``section 505(b)''; and
(3) by amending subsection (g) to read as follows:
``(g) Qualified Infectious Disease Product.--The term
`qualified infectious disease product' means a drug,
including an antibacterial or antifungal drug or a biological
product, for human use that--
``(1) acts directly on bacteria or fungi or on substances
produced by such bacteria or fungi; and
``(2) is intended to treat a serious or life-threatening
infection, including such an infection caused by--
``(A) an antibacterial or antifungal resistant pathogen,
including novel or emerging infectious pathogens; or
``(B) qualifying pathogens listed by the Secretary under
subsection (f).''.
(b) Priority Review.--Section 524A(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360n-1(a)) is amended by
inserting ``of this Act or section 351(a) of the Public
Health Service Act that requires clinical data (other than
bioavailability studies) to demonstrate safety or
effectiveness'' before the period at the end.
SEC. 706. NATIONAL CENTERS OF EXCELLENCE IN ADVANCED AND
CONTINUOUS PHARMACEUTICAL MANUFACTURING.
(a) In General.--Section 3016 of the 21st Century Cures Act
(21 U.S.C. 399h) is amended to read as follows:
[[Page H5310]]
``SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN ADVANCED AND
CONTINUOUS PHARMACEUTICAL MANUFACTURING.
``(a) In General.--The Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs--
``(1) shall solicit and, beginning not later than one year
after the date of enactment of the Prescription Drug User Fee
Amendments of 2022, receive requests from institutions of
higher education, or consortia of institutions of higher
education, to be designated as a National Center of
Excellence in Advanced and Continuous Pharmaceutical
Manufacturing (in this section referred to as a `National
Center of Excellence') to support the advancement,
development, and implementation of advanced and continuous
pharmaceutical manufacturing; and
``(2) shall so designate not more than 5 institutions of
higher education or consortia of such institutions that--
``(A) request such designation; and
``(B) meet the criteria specified in subsection (c).
``(b) Request for Designation.--A request for designation
under subsection (a) shall be made to the Secretary at such
time, in such manner, and containing such information as the
Secretary may require. Any such request shall include a
description of how the institution of higher education, or
consortium of institutions of higher education, meets or
plans to meet each of the criteria specified in subsection
(c).
``(c) Criteria for Designation Described.--The criteria
specified in this subsection with respect to an institution
of higher education, or consortium of institutions of higher
education, are that the institution or consortium has, as of
the date of the submission of a request under subsection (a)
by such institution or consortium--
``(1) physical and technical capacity for research,
development, implementation, and demonstration of advanced
and continuous pharmaceutical manufacturing;
``(2) manufacturing knowledge-sharing networks with other
institutions of higher education, large and small
pharmaceutical manufacturers, generic and nonprescription
manufacturers, contract manufacturers, and other relevant
entities;
``(3) proven capacity to design, develop, implement, and
demonstrate new, highly effective technologies for use in
advanced and continuous pharmaceutical manufacturing;
``(4) a track record for creating, preserving, and
transferring knowledge with respect to advanced and
continuous pharmaceutical manufacturing;
``(5) the proven ability to facilitate training of an
adequate future workforce for research on, and implementation
of, advanced and continuous pharmaceutical manufacturing; and
``(6) experience in participating in and leading advanced
and continuous pharmaceutical manufacturing technology
partnerships with other institutions of higher education,
large and small pharmaceutical manufacturers, generic and
nonprescription manufacturers, contract manufacturers, and
other relevant entities--
``(A) to support companies seeking to implement advanced
and continuous pharmaceutical manufacturing in the United
States;
``(B) to support Federal agencies with technical assistance
and employee training, which may include regulatory and
quality metric guidance as applicable, and hands-on training,
for advanced and continuous pharmaceutical manufacturing;
``(C) with respect to advanced and continuous
pharmaceutical manufacturing, to organize and conduct
research and development activities needed to create new and
more effective technology, develop and share knowledge,
create intellectual property, and maintain technological
leadership;
``(D) to develop best practices for designing and
implementing advanced and continuous pharmaceutical
manufacturing processes; and
``(E) to assess and respond to the national workforce needs
for advanced and continuous pharmaceutical manufacturing,
including the development and implementing of training
programs.
``(d) Termination of Designation.--The Secretary may
terminate the designation of any National Center of
Excellence designated under this section if the Secretary
determines such National Center of Excellence no longer meets
the criteria specified in subsection (c). Not later than 90
days before the effective date of such a termination, the
Secretary shall provide written notice to the National Center
of Excellence, including the rationale for such termination.
``(e) Conditions for Designation.--As a condition of
designation as a National Center of Excellence under this
section, the Secretary shall require that an institution of
higher education or consortium of institutions of higher
education enter into an agreement with the Secretary under
which the institution or consortium agrees--
``(1) to collaborate directly with the Food and Drug
Administration to publish the reports required by subsection
(g);
``(2) to share data with the Food and Drug Administration
regarding best practices and research generated through the
funding under subsection (f);
``(3) to develop, along with industry partners (which may
include large and small biopharmaceutical manufacturers,
generic and nonprescription manufacturers, and contract
research organizations or contract manufacturers that carry
out drug development and manufacturing activities) and
another institution or consortium designated under this
section, if any, a roadmap for developing an advanced and
continuous pharmaceutical manufacturing workforce;
``(4) to develop, along with industry partners and other
institutions or consortia of such institutions designated
under this section, a roadmap for strengthening existing, and
developing new, relationships with other institutions of
higher education or consortia thereof; and
``(5) to provide an annual report to the Food and Drug
Administration regarding the institution's or consortium's
activities under this section, including a description of how
the institution or consortium continues to meet and make
progress on the criteria specified in subsection (c).
``(f) Funding.--
``(1) In general.--The Secretary shall award funding,
through grants, contracts, or cooperative agreements, to the
National Centers of Excellence designated under this section
for the purpose of studying and recommending improvements to
advanced and continuous pharmaceutical manufacturing,
including such improvements as may enable the Centers--
``(A) to continue to meet the conditions specified in
subsection (e);
``(B) to expand capacity for research on, and development
of, advanced and continuous pharmaceutical manufacturing; and
``(C) to implement research infrastructure in advanced and
continuous pharmaceutical manufacturing suitable for
accelerating the development of drug products needed to
respond to emerging medical threats, such as emerging drug
shortages, quality issues disrupting the supply chain,
epidemics and pandemics, and other such situations requiring
the rapid development of new products or new manufacturing
processes.
``(2) Consistency with fda mission.--As a condition on
receipt of funding under this subsection, a National Center
of Excellence shall agree to consider any input from the
Secretary regarding the use of funding that would--
``(A) help to further the advancement of advanced and
continuous pharmaceutical manufacturing through the National
Center of Excellence; and
``(B) be relevant to the mission of the Food and Drug
Administration.
``(3) Rule of construction.--Nothing in this section shall
be construed as precluding a National Center for Excellence
designated under this section from receiving funds under any
other provision of this Act or any other Federal law.
``(g) Annual Review and Reports.--
``(1) Annual report.--Beginning not later than one year
after the date on which the first designation is made under
subsection (a), and annually thereafter, the Secretary
shall--
``(A) submit to Congress a report describing the
activities, partnerships and collaborations, Federal policy
recommendations, previous and continuing funding, and
findings of, and any other applicable information from, the
National Centers of Excellence designated under this section;
``(B) include in such report an accounting of the Federal
administrative expenses described in subsection (i)(2) over
the reporting period; and
``(C) make such report available to the public in an easily
accessible electronic format on the website of the Food and
Drug Administration.
``(2) Review of national centers of excellence and
potential designees.--The Secretary shall periodically review
the National Centers of Excellence designated under this
section to ensure that such National Centers of Excellence
continue to meet the criteria for designation under this
section.
``(3) Report on long-term vision of fda role.--Not later
than 2 years after the date on which the first designation is
made under subsection (a), the Secretary, in consultation
with the National Centers of Excellence designated under this
section, shall submit a report to the Congress on the long-
term vision of the Department of Health and Human Services on
the role of the Food and Drug Administration in supporting
advanced and continuous pharmaceutical manufacturing,
including--
``(A) a national framework of principles related to the
implementation and regulation of advanced and continuous
pharmaceutical manufacturing;
``(B) a plan for the development of Federal regulations and
guidance for how advanced and continuous pharmaceutical
manufacturing can be incorporated into the development of
pharmaceuticals and regulatory responsibilities of the Food
and Drug Administration;
``(C) a plan for development of Federal regulations or
guidance for how advanced and continuous pharmaceutical
manufacturing will be reviewed by the Food and Drug
Administration; and
``(D) appropriate feedback solicited from the public, which
may include other institutions of higher education, large and
small biopharmaceutical manufacturers, generic and
nonprescription manufacturers, and contract manufacturers.
``(h) Definitions.--In this section:
``(1) Advanced.--The term `advanced', with respect to
pharmaceutical manufacturing, refers to an approach that
incorporates novel technology, or uses an established
technique or technology in a new or innovative way,
[[Page H5311]]
that enhances drug quality or improves the performance of a
manufacturing process.
``(2) Continuous.--The term `continuous', with respect to
pharmaceutical manufacturing, refers to a process--
``(A) where the input materials are continuously fed into
and transformed within the process, and the processed output
materials are continuously removed from the system; and
``(B) that consists of an integrated process that consists
of a series of two or more simultaneous unit operations.
``(3) Institution of higher education.--The term
`institution of higher education' has the meaning given such
term in section 101(a) of the Higher Education Act of 1965
(20 U.S.C. 1001(a)).
``(4) Secretary.--The term `Secretary' means the Secretary
of Health and Human Services, acting through the Commissioner
of Food and Drugs.
``(i) Authorization of Appropriations.--
``(1) In general.--There is authorized to be appropriated
to carry out this section $100,000,000 for the period of
fiscal years 2023 through 2027.
``(2) Federal administrative expenses.--Of the amounts made
available to carry out this section for a fiscal year, the
Secretary shall not use more than eight percent for Federal
administrative expenses, including training, technical
assistance, reporting, and evaluation.''.
(b) Transition Rule.--Section 3016 of the 21st Century
Cures Act (21 U.S.C. 399h), as in effect on the day before
the date of the enactment of this section, shall apply with
respect to grants awarded under such section before such date
of enactment.
(c) Clerical Amendment.--The item relating to section 3016
in the table of contents in section 1(b) of the 21st Century
Cures Act (Public Law 114-255) is amended to read as follows:
``Sec. 3016. National Centers of Excellence in Advanced and Continuous
Pharmaceutical Manufacturing.''.
SEC. 707. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION
PILOT PROGRAM.
Subchapter A of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 506J (21 U.S.C. 356j) the following:
``SEC. 506K. ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION
PILOT PROGRAM.
``(a) In General.--Not later than 1 year after the date of
enactment of this section, the Secretary shall initiate a
pilot program under which persons may request designation of
an advanced manufacturing technology as described in
subsection (b).
``(b) Designation Process.--The Secretary shall establish a
process for the designation under this section of methods of
manufacturing drugs, including biological products, and
active pharmaceutical ingredients of such drugs, as advanced
manufacturing technologies. A method of manufacturing, or a
combination of manufacturing methods, is eligible for
designation as an advanced manufacturing technology if such
method or combination of methods incorporates a novel
technology, or uses an established technique or technology in
a novel way, that will substantially improve the
manufacturing process for a drug and maintain equivalent or
provide superior drug quality, including by--
``(1) reducing development time for a drug using the
designated manufacturing method; or
``(2) increasing or maintaining the supply of--
``(A) a drug that is described in section 506C(a) and is
intended to treat a serious or life-threatening condition; or
``(B) a drug that is on the drug shortage list under
section 506E.
``(c) Evaluation and Designation of an Advanced
Manufacturing Technology.--
``(1) Submission.--A person who requests designation of a
method of manufacturing as an advanced manufacturing
technology under this section shall submit to the Secretary
data or information demonstrating that the method of
manufacturing meets the criteria described in subsection (b)
in a particular context of use. The Secretary may facilitate
the development and review of such data or information by--
``(A) providing timely advice to, and interactive
communication with, such person regarding the development of
the method of manufacturing; and
``(B) involving senior managers and experienced staff of
the Food and Drug Administration, as appropriate, in a
collaborative, cross-disciplinary review of the method of
manufacturing, as applicable.
``(2) Evaluation and designation.--Not later than 180
calendar days after the receipt of a request under paragraph
(1), the Secretary shall determine whether to designate such
method of manufacturing as an advanced manufacturing
technology, in a particular context of use, based on the data
and information submitted under paragraph (1) and the
criteria described in subsection (b).
``(d) Review of Advanced Manufacturing Technologies.--If
the Secretary designates a method of manufacturing as an
advanced manufacturing technology, the Secretary shall--
``(1) expedite the development and review of an application
submitted under section 505 of this Act or section 351 of the
Public Health Service Act, including supplemental
applications, for drugs that are manufactured using a
designated advanced manufacturing technology and could help
mitigate or prevent a shortage or substantially improve
manufacturing processes for a drug and maintain equivalent or
provide superior drug quality, as described in subsection
(b); and
``(2) allow the holder of an advanced technology
designation, or a person authorized by the advanced
manufacturing technology designation holder, to reference or
rely upon, in an application submitted under section 505 of
this Act or section 351 of the Public Health Service Act,
including a supplemental application, data and information
about the designated advanced manufacturing technology for
use in manufacturing drugs in the same context of use for
which the designation was granted.
``(e) Implementation and Evaluation of Advanced
Manufacturing Technologies Pilot.--
``(1) Public meeting.--The Secretary shall publish in the
Federal Register a notice of a public meeting, to be held not
later than 180 days after the date of enactment of this
section, to discuss and obtain input and recommendations from
relevant stakeholders regarding--
``(A) the goals and scope of the pilot program, and a
suitable framework, procedures, and requirements for such
program; and
``(B) ways in which the Food and Drug Administration will
support the use of advanced manufacturing technologies and
other innovative manufacturing approaches for drugs.
``(2) Pilot program guidance.--
``(A) In general.--The Secretary shall--
``(i) not later than 180 days after the public meeting
under paragraph (1), issue draft guidance regarding the goals
and implementation of the pilot program under this section;
and
``(ii) not later than 2 years after the date of enactment
of this section, issue final guidance regarding the
implementation of such program.
``(B) Content.--The guidance described in subparagraph (A)
shall address--
``(i) the process by which a person may request a
designation under subsection (b);
``(ii) the data and information that a person requesting
such a designation is required to submit under subsection
(c), and how the Secretary intends to evaluate such
submissions;
``(iii) the process to expedite the development and review
of applications under subsection (d); and
``(iv) the criteria described in subsection (b) for
eligibility for such a designation.
``(3) Report.--Not later than 3 years after the date of
enactment of this section and annually thereafter, the
Secretary shall publish on the website of the Food and Drug
Administration and submit to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report containing a description and
evaluation of the pilot program being conducted under this
section, including the types of innovative manufacturing
approaches supported under the program. Such report shall
include the following:
``(A) The number of persons that have requested
designations and that have been granted designations.
``(B) The number of methods of manufacturing that have been
the subject of designation requests and that have been
granted designations.
``(C) The average number of calendar days for completion of
evaluations under subsection (c)(2).
``(D) An analysis of the factors in data submissions that
are relevant to determinations to designate and not to
designate after evaluation under subsection (c)(2).
``(E) The number of applications received under section 505
of this Act or section 351 of the Public Health Service Act,
including supplemental applications, that have included an
advanced manufacturing technology designated under this
section, and the number of such applications approved.
``(f) Sunset.--The Secretary--
``(1) may not consider any requests for designation
submitted under subsection (c) after October 1, 2029; and
``(2) may continue all activities under this section with
respect to advanced manufacturing technologies that were
designated pursuant to subsection (d) prior to such date, if
the Secretary determines such activities are in the interest
of the public health.''.
SEC. 708. PUBLIC WORKSHOP ON CELL THERAPIES.
Not later than 3 years after the date of the enactment of
this Act, the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall convene a
public workshop with relevant stakeholders to discuss best
practices on generating scientific data necessary to further
facilitate the development of certain human cell-, tissue-,
and cellular-based medical products (and the latest
scientific information about such products) that are
regulated as drugs under the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.) and biological products under
section 351 of the Public Health Service Act (42 U.S.C. 262),
namely, stem-cell and other cellular therapies.
SEC. 709. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR
CHILDREN.
Section 409I(d)(1) of the Public Health Service Act (42
U.S.C. 284m(d)(1)) is amended by striking ``2018 through
2022'' and inserting ``2023 through 2027''.
[[Page H5312]]
SEC. 710. REAUTHORIZATION FOR HUMANITARIAN DEVICE EXEMPTION
AND DEMONSTRATION GRANTS FOR IMPROVING
PEDIATRIC AVAILABILITY.
(a) Humanitarian Device Exemption.--Section
520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking ``2022''
and inserting ``2027''.
(b) Pediatric Medical Device Safety and Improvement Act.--
Section 305(e) of the Pediatric Medical Device Safety and
Improvement Act of 2007 (Public Law 110-85) is amended by
striking ``2018 through 2022'' and inserting ``2023 through
2027''.
SEC. 711. REAUTHORIZATION OF PROVISION RELATED TO EXCLUSIVITY
OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(u)(4)) is amended by striking ``2022'' and
inserting ``2027''.
SEC. 712. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIP PROGRAM.
Section 566(f) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb-5(f)) is amended by striking ``$6,000,000
for each of fiscal years 2018 through 2022'' and inserting
``$10,000,000 for each of fiscal years 2023 through 2027''.
SEC. 713. REAUTHORIZATION OF ORPHAN DRUG GRANTS.
Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is
amended--
(1) in subsection (a)--
(A) by striking ``and (3)'' and inserting ``(3)''; and
(B) by inserting before the period at the end the
following: ``, and (4) developing regulatory science
pertaining to the chemistry, manufacturing, and controls of
individualized medical products to treat individuals with
rare diseases or conditions''; and
(2) in subsection (c), by striking ``2018 through 2022''
and inserting ``2023 through 2027''.
SEC. 714. 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 (as determined
by the Secretary) 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 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 to be 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 has been previously
approved to treat an adult cancer.
``(iii) Results of already-completed preclinical studies of
application drug.--The Secretary may require that reports on
an investigation required pursuant to paragraph (1)(B)
include the results of all preclinical studies on which the
decision to conduct such investigation was based.
``(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) shall apply 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 shall--
(1) not later than 12 months after the date of enactment of
this Act, issue draft guidance on the implementation of the
requirements in 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), 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
2 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 3 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.
(B) Findings.--Not later than 7 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).
Subtitle B--Inspections
SEC. 721. FACTORY INSPECTION.
(a) In General.--Section 704(a)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by
striking ``restricted devices'' each place it appears and
inserting ``devices''.
(b) Records or Other Information.--
(1) Establishments.--Section 704(a)(4)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is
amended--
(A) by striking ``an establishment that is engaged in the
manufacture, preparation, propagation, compounding, or
processing of a drug'' and inserting ``an establishment that
is engaged in the manufacture, preparation, propagation,
compounding, or processing of a drug or device, or that is
subject to inspection under paragraph (5)(C),''; and
(B) by inserting after ``a sufficient description of the
records requested'' the following: ``and a rationale for
requesting such records or other information in advance of,
or in lieu of, an inspection''.
(2) Guidance.--
(A) In general.--The Secretary of Health and Human Services
shall issue or update guidance describing--
(i) circumstances in which the Secretary intends to issue
requests for records or other information in advance of, or
in lieu of, an inspection under section 704(a)(4) of the
Federal Food, Drug, and Cosmetic Act, as amended by paragraph
(1);
(ii) processes for responding to such requests
electronically or in physical form; and
(iii) factors the Secretary intends to consider in
evaluating whether such records and other information are
provided within a reasonable timeframe, within reasonable
limits, and in a reasonable manner, accounting for resource
and other limitations that may exist, including for small
businesses.
(B) Timing.--The Secretary of Health and Human Services
shall--
(i) not later than 1 year after the date of enactment of
this Act, issue draft guidance under subparagraph (A); and
[[Page H5313]]
(ii) not later than 1 year after the close of the comment
period for such draft guidance, issue final guidance under
subparagraph (A).
(c) Bioresearch Monitoring Inspections.--
(1) In general.--Section 704(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 374(a)) is amended by adding at
the end the following:
``(5) Bioresearch monitoring inspections.--
``(A) In general.--The Secretary may, to ensure the
accuracy and reliability of studies and records or other
information described in subparagraph (B) and to assess
compliance with applicable requirements under this Act or the
Public Health Service Act, enter sites and facilities
specified in subparagraph (C) in order to inspect such
records or other information.
``(B) Information subject to inspection.--An inspection
under this paragraph shall extend to all records and other
information related to the studies and submissions described
in subparagraph (E), including records and information
related to the conduct, results, and analyses of, and the
protection of human and animal trial participants
participating in, such studies.
``(C) Sites and facilities subject to inspection.--
``(i) Sites and facilities described.--The sites and
facilities subject to inspection by the Secretary under this
paragraph are those owned or operated by a person described
in clause (ii) and which are (or were) utilized by such
person in connection with--
``(I) developing an application or other submission to the
Secretary under this Act or the Public Health Service Act
related to marketing authorization for a product described in
paragraph (1);
``(II) preparing, conducting, or analyzing the results of a
study described in subparagraph (E); or
``(III) holding any records or other information described
in subparagraph (B).
``(ii) Persons described.--A person described in this
clause is--
``(I) the sponsor of an application or submission specified
in subparagraph (E);
``(II) a person engaged in any activity described in clause
(i) on behalf of such a sponsor, through a contract, grant,
or other business arrangement with such sponsor;
``(III) an institutional review board, or other individual
or entity, engaged by contract, grant, or other business
arrangement with a nonsponsor in preparing, collecting, or
analyzing records or other information described in
subparagraph (B); or
``(IV) any person not otherwise described in this clause
that conducts, or has conducted, a study described in
subparagraph (E) yielding records or other information
described in subparagraph (B).
``(D) Conditions of inspection.--
``(i) Access to information subject to inspection.--Subject
to clause (ii), an entity that owns or operates any site or
facility subject to inspection under this paragraph shall
provide the Secretary with access to records and other
information described in subparagraph (B) that is held by or
under the control of such entity, including--
``(I) permitting the Secretary to record or copy such
information for purposes of this paragraph;
``(II) providing the Secretary with access to any
electronic information system utilized by such entity to
hold, process, analyze, or transfer any records or other
information described in subparagraph (B); and
``(III) permitting the Secretary to inspect the facilities,
equipment, written procedures, processes, and conditions
through which records or other information described in
subparagraph (B) is or was generated, held, processed,
analyzed, or transferred.
``(ii) No effect on applicability of provisions for
protection of proprietary information or trade secrets.--
Nothing in clause (i) shall negate, supersede, or otherwise
affect the applicability of provisions, under this or any
other Act, preventing or limiting the disclosure of
confidential commercial information or other information
considered proprietary or trade secret.
``(iii) Reasonableness of inspections.--An inspection under
this paragraph shall be conducted at reasonable times and
within reasonable limits and in a reasonable manner.
``(E) Studies and submissions described.--The studies and
submissions described in this subparagraph are each of the
following:
``(i) Clinical and nonclinical studies submitted to the
Secretary in support of, or otherwise related to,
applications and other submissions to the Secretary under
this Act or the Public Health Service Act for marketing
authorization of a product described in paragraph (1).
``(ii) Postmarket safety activities conducted under this
Act or the Public Health Service Act.
``(iii) Any other clinical investigation of--
``(I) a drug subject to section 505 or 512 of this Act or
section 351 of the Public Health Service Act; or
``(II) a device subject to section 520(g).
``(iv) Any other submissions made under this Act or the
Public Health Service Act with respect to which the Secretary
determines an inspection under this paragraph is warranted in
the interest of public health.
``(F) Clarification.--This paragraph clarifies the
authority of the Secretary to conduct inspections of the type
described in this paragraph and shall not be construed as a
basis for inferring that, prior to the date of enactment of
this paragraph, the Secretary lacked the authority to conduct
such inspections, including under this Act or the Public
Health Service Act.''.
(2) Review of processes and practices; guidance for
industry.--
(A) In general.--The Secretary of Health and Human Services
shall--
(i) review processes and practices in effect as of the date
of enactment of this Act applicable to inspections of foreign
and domestic sites and facilities described in subparagraph
(C)(i) of section 704(a)(5) of the Federal Food, Drug, and
Cosmetic Act, as added by paragraph (1); and
(ii) evaluate whether any updates are needed to facilitate
the consistency of such processes and practices.
(B) Guidance.--
(i) In general.--The Secretary of Health and Human Services
shall issue guidance describing the processes and practices
applicable to inspections of sites and facilities described
in subparagraph (C)(i) of section 704(a)(5) of the Federal
Food, Drug, and Cosmetic Act, as added by paragraph (1),
including with respect to the types of records and
information required to be provided, best practices for
communication between the Food and Drug Administration and
industry in advance of or during an inspection or request for
records or other information, and other inspections-related
conduct, to the extent not specified in existing publicly
available Food and Drug Administration guides and manuals for
such inspections.
(ii) Timing.--The Secretary of Health and Human Services
shall--
(I) not later than 18 months after the date of enactment of
this Act, issue draft guidance under clause (i); and
(II) not later than 1 year after the close of the public
comment period for such draft guidance, issue final guidance
under clause (i).
SEC. 722. USES OF CERTAIN EVIDENCE.
Section 703 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 373) is amended by adding at the end the following:
``(c) Applicability.--The limitations on the Secretary's
use of evidence obtained under this section, or any evidence
which is directly or indirectly derived from such evidence,
in a criminal prosecution of the person from whom such
evidence was obtained shall not apply to evidence, including
records or other information, obtained under authorities
other than this section, unless such limitations are
specifically incorporated by reference in such other
authorities.''.
SEC. 723. IMPROVING FDA INSPECTIONS.
(a) Risk Factors for Establishments.--Section 510(h)(4) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360(h)(4)) is amended--
(1) by redesignating subparagraph (F) as subparagraph (G);
and
(2) by inserting after subparagraph (E) the following:
``(F) The compliance history of establishments in the
country or region in which the establishment is located that
are subject to regulation under this Act, including the
history of violations related to products exported from such
country or region that are subject to such regulation.''.
(b) Use of Records.--Section 704(a)(4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)) is amended--
(1) by redesignating subparagraph (C) as subparagraph (D);
and
(2) by inserting after subparagraph (B) the following:
``(C) The Secretary may rely on any records or other
information that the Secretary may inspect under this section
to satisfy requirements that may pertain to a preapproval or
risk-based surveillance inspection, or to resolve
deficiencies identified during such inspections, if
applicable and appropriate.''.
(c) Recognition of Foreign Government Inspections.--Section
809 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
384e) is amended--
(1) in subsection (a)(1), by inserting ``preapproval or''
before ``risk-based inspections''; and
(2) by adding at the end the following:
``(c) Periodic Review.--
``(1) In general.--Beginning not later than 1 year after
the date of the enactment of the Food and Drug Amendments of
2022, the Secretary shall periodically assess whether
additional arrangements and agreements with a foreign
government or an agency of a foreign government, as allowed
under this section, are appropriate.
``(2) Reports to congress.--Beginning not later than 4
years after the date of the enactment of the Food and Drug
Amendments of 2022, and every 4 years thereafter, 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 report
describing the findings and conclusions of each review
conducted under paragraph (1).''.
SEC. 724. GAO REPORT ON INSPECTIONS OF FOREIGN ESTABLISHMENTS
MANUFACTURING DRUGS.
(a) In General.--Not later than 18 months 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
on inspections conducted by--
[[Page H5314]]
(1) the Secretary of Health and Human Services (in this
section referred to as the ``Secretary'') of foreign
establishments pursuant to subsections (h) and (i) of section
510 and section 704 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360; 374); or
(2) a foreign government or an agency of a foreign
government pursuant to section 809 of such Act (21 U.S.C.
384e).
(b) Contents.--The report conducted under subsection (a)
shall include--
(1) what alternative tools, including remote inspections or
remote evaluations, other countries are utilizing to
facilitate inspections of foreign establishments;
(2) how frequently trusted foreign regulators conduct
inspections of foreign facilities that could be useful to the
Food and Drug Administration to review in lieu of its own
inspections;
(3) how frequently and under what circumstances, including
for what types of inspections, the Secretary utilizes
existing agreements or arrangements under section 809 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e) and
whether the use of such agreements could be appropriately
expanded;
(4) whether the Secretary has accepted reports of
inspections of facilities in China and India conducted by
entities with which they have entered into such an agreement
or arrangement;
(5) what additional foreign governments or agencies of
foreign governments the Secretary has considered entering
into a mutual recognition agreement with and, if applicable,
reasons why the Secretary declined to enter into a mutual
recognition agreement with such foreign governments or
agencies;
(6) what tools, if any, the Secretary used to facilitate
inspections of domestic facilities that could also be
effectively utilized to appropriately inspect foreign
facilities;
(7) what steps the Secretary has taken to identify and
evaluate tools and strategies the Secretary may use to
continue oversight with respect to inspections when in-person
inspections are disrupted;
(8) how the Secretary is considering incorporating
alternative tools into the inspection activities conducted
pursuant to the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.); and
(9) what steps the Secretary has taken to identify and
evaluate how the Secretary may use alternative tools to
address workforce shortages to carry out such inspection
activities.
SEC. 725. UNANNOUNCED FOREIGN FACILITY INSPECTIONS PILOT
PROGRAM.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
conduct a pilot program under which the Secretary increases
the conduct of unannounced surveillance inspections of
foreign human drug establishments and evaluates the
differences between such inspections of domestic and foreign
human drug establishments, including the impact of announcing
inspections to persons who own or operate foreign human drug
establishments in advance of an inspection. Such pilot
program shall evaluate--
(1) differences in the number and type of violations of
section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351(a)(2)(B)) identified as a result of
unannounced and announced inspections of foreign human drug
establishments and any other significant differences between
each type of inspection;
(2) costs and benefits associated with conducting announced
and unannounced inspections of foreign human drug
establishments;
(3) barriers to conducting unannounced inspections of
foreign human drug establishments and any challenges to
achieving parity between domestic and foreign human drug
establishment inspections; and
(4) approaches for mitigating any negative effects of
conducting announced inspections of foreign human drug
establishments.
(b) Pilot Program Scope.--The inspections evaluated under
the pilot program under this section shall be routine
surveillance inspections and shall not include inspections
conducted as part of the Secretary's evaluation of a request
for approval to market a drug submitted under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the
Public Health Service Act (42 U.S.C. 201 et seq.).
(c) Pilot Program Initiation.--The Secretary shall initiate
the pilot program under this section not later than 180 days
after the date of enactment of this Act.
(d) Report.--The Secretary shall, not later than 180 days
following the completion of the pilot program under this
section, make available on the website of the Food and Drug
Administration a final report on the pilot program under this
section, including--
(1) findings and any associated recommendations with
respect to the evaluation under subsection (a), including any
recommendations to address identified barriers to conducting
unannounced inspections of foreign human drug establishments;
(2) findings and any associated recommendations regarding
how the Secretary may achieve parity between domestic and
foreign human drug inspections; and
(3) the number of unannounced inspections during the pilot
program that would not be unannounced under existing
practices.
SEC. 726. REAUTHORIZATION OF INSPECTION PROGRAM.
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 374(g)(11)) is amended by striking ``2022''
and inserting ``2027''.
SEC. 727. ENHANCING INTRA-AGENCY COORDINATION AND PUBLIC
HEALTH ASSESSMENT WITH REGARD TO COMPLIANCE
ACTIVITIES.
(a) Coordination.--Section 506D of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356d) is amended by adding at the
end the following:
``(g) Coordination.--The Secretary shall ensure timely and
effective internal coordination and alignment among the field
investigators of the Food and Drug Administration and the
staff of the Center for Drug Evaluation and Research's Office
of Compliance and Drug Shortage Program regarding--
``(1) the reviews of reports shared pursuant to section
704(b)(2); and
``(2) any feedback or corrective or preventive actions in
response to such reports.''.
(b) Reporting.--
(1) In general.--Section 506C-1(a)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356c-1(a)(2)) is amended to
read as follows:
``(2)(A) describes the communication between the field
investigators of the Food and Drug Administration and the
staff of the Center for Drug Evaluation and Research's Office
of Compliance and Drug Shortage Program, including the Food
and Drug Administration's procedures for enabling and
ensuring such communication;
``(B) provides the number of reports described in section
704(b)(2) that were required to be sent to the appropriate
offices of the Food and Drug Administration and the number of
such reports that were sent; and
``(C) describes the coordination and alignment activities
undertaken pursuant to section 506D(g);''.
(2) Applicability.--The amendment made by paragraph (1)
shall apply with respect to reports submitted on or after
March 31, 2023.
SEC. 728. REPORTING OF MUTUAL RECOGNITION AGREEMENTS FOR
INSPECTIONS AND REVIEW ACTIVITIES.
(a) In General.--Not later than December 31, 2022, and
annually thereafter, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall publish a report on the public website of the Food and
Drug Administration on the utilization of agreements entered
into pursuant to section 809 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 384e) or otherwise entered into by
the Secretary in the previous fiscal year to recognize
inspections between drug regulatory authorities across
countries and international regions with analogous review
criteria to the Food and Drug Administration, such as the
Pharmaceutical Inspection Co-Operation Scheme, the Mutual
Recognition Agreement with the European Union, and the
Australia-Canada-Singapore-Switzerland-United Kingdom
Consortium.
(b) Content.--The report under subsection (a) shall include
each of the following:
(1) The total number of establishments that are registered
under section 510(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(i)), and the number of such establishments
in each region of interest.
(2) The total number of inspections conducted at
establishments described in paragraph (1), disaggregated by
inspections conducted--
(A) pursuant to an agreement or other recognition described
in subsection (a); and
(B) by employees or contractors of the Food and Drug
Administration.
(3) Of the inspections described in paragraph (2), the
total number of inspections in each region of interest.
(4) Of the inspections in each region of interest reported
pursuant to paragraph (3), the number of inspections in each
FDA inspection category.
(5) Of the number of inspections reported under each of
paragraphs (3) and (4)--
(A) the number of inspections which have been conducted
pursuant to an agreement or other recognition described in
subsection (a); and
(B) the number of inspections which have been conducted by
employees or contractors of the Food and Drug Administration.
(c) Definitions.--In this section:
(1) FDA inspection category.--The term ``FDA inspection
category'' means the following inspection categories:
(A) Inspections to support approvals of changes to the
manufacturing process of drugs approved under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
section 351 of the Public Health Service Act (42 U.S.C. 262).
(B) Surveillance inspections.
(C) For-cause inspections.
(2) Region of interest.--The term ``region of interest''
means China, India, the European Union, and any other
geographic region as the Secretary determines appropriate.
SEC. 729. ENHANCING TRANSPARENCY OF DRUG FACILITY INSPECTION
TIMELINES.
Section 902 of the FDA Reauthorization Act of 2017 (21
U.S.C. 355 note) is amended to read as follows:
``SEC. 902. ANNUAL REPORT ON INSPECTIONS.
``Not later than 120 days after the end of each fiscal
year, the Secretary of Health and Human Services shall post
on the public website of the Food and Drug Administration
information related to inspections of facilities necessary
for approval of a drug under subsection (c) or (j) of section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355), approval of a device under section 515 of such Act (21
U.S.C. 360e), or clearance of a device under section 510(k)
of
[[Page H5315]]
such Act (21 U.S.C. 360(k)) that were conducted during the
previous fiscal year. Such information shall include the
following:
``(1) The median time following a request from staff of the
Food and Drug Administration reviewing an application or
report to the beginning of the inspection, including--
``(A) the median time for drugs described in section
505(j)(11)(A)(i) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)(11)(A)(i));
``(B) the median time for drugs described in section
506C(a) of such Act (21 U.S.C. 356c(a)) only; and
``(C) the median time for drugs on the drug shortage list
in effect under section 506E of such Act (21 U.S.C. 356e).
``(2) The median time from the issuance of a report
pursuant to section 704(b) of such Act (21 U.S.C. 374(b)) to
the sending of a warning letter, issuance of an import alert,
or holding of a regulatory meeting for inspections for which
the Secretary concluded that regulatory or enforcement action
was indicated, including the median time for each category of
drugs listed in subparagraphs (A) through (C) of paragraph
(1).
``(3) The median time from the sending of a warning letter,
issuance of an import alert, or holding of a regulatory
meeting to resolution of the actions indicated to address the
conditions or practices observed during an inspection.
``(4) The number of facilities that failed to implement
adequate corrective or preventive actions following a report
pursuant to such section 704(b), resulting in a withhold
recommendation, including the number of such times for each
category of drugs listed in subparagraphs (A) through (C) of
paragraph (1).''.
TITLE VIII--TRANSPARENCY, PROGRAM INTEGRITY, AND REGULATORY
IMPROVEMENTS
SEC. 801. PROMPT REPORTS OF MARKETING STATUS BY HOLDERS OF
APPROVED APPLICATIONS FOR BIOLOGICAL PRODUCTS.
(a) In General.--Section 506I of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356i) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1), by striking
``The holder of an application approved under subsection (c)
or (j) of section 505'' and inserting ``The holder of an
application approved under subsection (c) or (j) of section
505 of this Act or subsection (a) or (k) of section 351 of
the Public Health Service Act'';
(B) in paragraph (2), by striking ``established name'' and
inserting ``established name (for biological products, by
proper name)''; and
(C) in paragraph (3), by striking ``or abbreviated
application number'' and inserting ``, abbreviated
application number, or biologics license application
number''; and
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by striking
``The holder of an application approved under subsection (c)
or (j)'' and inserting ``The holder of an application
approved under subsection (c) or (j) of section 505 of this
Act or subsection (a) or (k) of section 351 of the Public
Health Service Act'';
(B) in paragraph (1), by striking ``established name'' and
inserting ``established name (for biological products, by
proper name)''; and
(C) in paragraph (2), by striking ``or abbreviated
application number'' and inserting ``, abbreviated
application number, or biologics license application
number''.
(b) Additional One-Time Report.--Subsection (c) of section
506I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356i) is amended to read as follows:
``(c) Additional One-Time Report.--Within 180 days of the
date of enactment of the Food and Drug Amendments of 2022,
all holders of applications approved under subsection (a) or
(k) of section 351 of the Public Health Service Act shall
review the information in the list published under section
351(k)(9)(A) and shall submit a written notice to the
Secretary--
``(1) stating that all of the application holder's
biological products in the list published under section
351(k)(9)(A) that are not listed as discontinued are
available for sale; or
``(2) including the information required pursuant to
subsection (a) or (b), as applicable, for each of the
application holder's biological products that are in the list
published under section 351(k)(9)(A) and not listed as
discontinued, but have been discontinued from sale or never
have been available for sale.''.
(c) Purple Book.--Section 506I of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356i) is amended--
(1) by striking subsection (d) and inserting the following:
``(d) Failure To Meet Requirements.--If a holder of an
approved application fails to submit the information required
under subsection (a), (b), or (c), the Secretary may--
``(1) move the application holder's drugs from the active
section of the list published under section 505(j)(7)(A) to
the discontinued section of the list, except that the
Secretary shall remove from the list in accordance with
section 505(j)(7)(C) drugs the Secretary determines have been
withdrawn from sale for reasons of safety or effectiveness;
and
``(2) identify the application holder's biological products
as discontinued in the list published under section
351(k)(9)(A) of the Public Health Service Act, except that
the Secretary shall remove from the list in accordance with
section 351(k)(9)(B) of such Act biological products for
which the license has been revoked or suspended for reasons
of safety, purity, or potency.''; and
(2) in subsection (e)--
(A) by inserting after the first sentence the following:
``The Secretary shall update the list published under section
351(k)(9)(A) of the Public Health Service Act based on
information provided under subsections (a), (b), and (c) by
identifying as discontinued biological products that are not
available for sale, except that biological products for which
the license has been revoked or suspended for safety, purity,
or potency reasons shall be removed from the list in
accordance with section 351(k)(9)(B) of the Public Health
Service Act.'';
(B) by striking ``monthly updates to the list'' and
inserting ``monthly updates to the lists referred to in the
preceding sentences''; and
(C) by striking ``and shall update the list based on'' and
inserting ``and shall update such lists based on''.
(d) Technical Corrections.--Section 506I(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356i(e)) is amended--
(1) by striking ``subsection 505(j)(7)(A)'' and inserting
``section 505(j)(7)(A)''; and
(2) by striking ``subsection 505(j)(7)(C)'' and inserting
``section 505(j)(7)(C)''.
SEC. 802. ENCOURAGING BLOOD DONATION.
(a) Streamlining Patient and Blood Donor Input.--Section
3003 of the 21st Century Cures Act (21 U.S.C. 360bbb-8c note)
is amended to read as follows:
``SEC. 3003. STREAMLINING PATIENT AND BLOOD DONOR INPUT.
``Chapter 35 of title 44, United States Code, shall not
apply to the collection of information to which a response is
voluntary, to solicit--
``(1) the views and perspectives of patients under section
569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-8c) (as amended by section 3001) or section 3002; or
``(2) information from blood donors or potential blood
donors to support the development of recommendations by the
Secretary of Health and Human Services acting through the
Commissioner of Food and Drugs concerning blood donation.''.
(b) Clerical Amendment.--The table of contents in section
1(b) of the 21st Century Cures Act is amended by striking the
item relating to section 3003 and inserting the following:
``Sec. 3003. Streamlining patient and blood donor input.''.
SEC. 803. REGULATION OF CERTAIN PRODUCTS AS DRUGS.
Section 503 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353) is amended by adding at the end the following:
``(h)(1) Any contrast agent, radioactive drug, or OTC
monograph drug shall be deemed to be a drug under section
201(g) and not a device under section 201(h).
``(2) For purposes of this subsection:
``(A) The term `contrast agent' means an article that is
intended for use in conjunction with a medical imaging
device, and--
``(i) is a diagnostic radiopharmaceutical, as defined in
sections 315.2 and 601.31 of title 21, Code of Federal
Regulations (or any successor regulations); or
``(ii) is a diagnostic agent that improves the
visualization of structure or function within the body by
increasing the relative difference in signal intensity within
the target tissue, structure, or fluid.
``(B) The term `radioactive drug' has the meaning given
such term in section 310.3(n) of title 21, Code of Federal
Regulations (or any successor regulations), except that such
term does not include--
``(i) an implant or article similar to an implant;
``(ii) an article that applies radiation from outside of
the body; or
``(iii) the radiation source of an article described in
clause (i) or (ii).
``(C) The term `OTC monograph drug' has the meaning given
such term in section 744L.
``(3) Nothing in this subsection shall be construed as
allowing for the classification of a product as a drug (as
defined in section 201(g)) if such product--
``(A) is not described in paragraph (1); and
``(B) meets the definition of a device under section
201(h),
unless another provision of this Act otherwise indicates a
different classification.''.
SEC. 804. POSTAPPROVAL STUDIES AND PROGRAM INTEGRITY FOR
ACCELERATED APPROVAL DRUGS.
(a) In General.--Section 506(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356(c)) is amended--
(1) by striking paragraph (2) and inserting the following:
``(2) Limitation.--
``(A) In general.--Approval of a product under this
subsection may be subject to 1 or both of the following
requirements:
``(i) That the sponsor conduct an appropriate postapproval
study or studies (which may be augmented or supported by real
world evidence) to verify and describe the predicted effect
on irreversible morbidity or mortality or other clinical
benefit.
``(ii) That the sponsor submit copies of all promotional
materials related to the product during the preapproval
review period and, following approval and for such period
thereafter as the Secretary determines to be appropriate, at
least 30 days prior to dissemination of the materials.
[[Page H5316]]
``(B) Studies not required.--If the Secretary does not
require that the sponsor of a product approved under
accelerated approval conduct a postapproval study under this
paragraph, the Secretary shall publish on the website of the
Food and Drug Administration the rationale for why such study
is not appropriate or necessary.
``(C) Postapproval study conditions.--Not later than the
time of approval of a product under accelerated approval, the
Secretary shall specify the conditions for a postapproval
study or studies required to be conducted under this
paragraph with respect to such product, which may include
enrollment targets, the study protocol, and milestones,
including the target date of study completion.
``(D) Studies begun before approval.--The Secretary may
require such study or studies to be underway prior to
approval.''; and
(2) by striking paragraph (3) and inserting the following:
``(3) Expedited withdrawal of approval.--
``(A) In general.--The Secretary may withdraw approval of a
product approved under accelerated approval using expedited
procedures described in subparagraph (B), if--
``(i) the sponsor fails to conduct any required
postapproval study of the product with due diligence,
including with respect to conditions specified by the
Secretary under paragraph (2)(C);
``(ii) a study required to verify and describe the
predicted effect on irreversible morbidity or mortality or
other clinical benefit of the product fails to verify and
describe such effect or benefit;
``(iii) other evidence demonstrates that the product is not
shown to be safe or effective under the conditions of use; or
``(iv) the sponsor disseminates false or misleading
promotional materials with respect to the product.
``(B) Expedited procedures described.--Expedited procedures
described in this subparagraph shall consist of, prior to the
withdrawal of accelerated approval--
``(i) providing the sponsor with--
``(I) due notice;
``(II) an explanation for the proposed withdrawal;
``(III) an opportunity for a meeting with the Commissioner
of Food and Drugs or the Commissioner's designee; and
``(IV) an opportunity for written appeal to--
``(aa) the Commissioner of Food and Drugs; or
``(bb) a designee of the Commissioner who has not
participated in the proposed withdrawal of approval (other
than a meeting pursuant to subclause (III)) and is not a
subordinate of an individual (other than the Commissioner)
who participated in such proposed withdrawal;
``(ii) providing an opportunity for public comment on the
notice proposing to withdraw approval;
``(iii) the publication of a summary of the public comments
received, and the Secretary's response to such comments, on
the website of the Food and Drug Administration; and
``(iv) convening and consulting an advisory committee on
issues related to the proposed withdrawal, if requested by
the sponsor and if no such advisory committee has previously
advised the Secretary on such issues with respect to the
withdrawal of the product prior to the sponsor's request.
``(4) Labeling.--
``(A) In general.--Subject to subparagraph (B), the
labeling for a product approved under accelerated approval
shall include--
``(i) a statement indicating that the product was approved
under accelerated approval;
``(ii) a statement indicating that continued approval of
the product is subject to postmarketing studies to verify
clinical benefit;
``(iii) identification of the surrogate or intermediate
endpoint or endpoints that supported approval and any known
limitations of such surrogate or intermediate endpoint or
endpoints in determining clinical benefit; and
``(iv) a succinct description of the product and any
uncertainty about anticipated clinical benefit and a
discussion of available evidence with respect to such
clinical benefit.
``(B) Applicability.--The labeling requirements of
subparagraph (A) shall apply only to products approved under
accelerated approval for which the predicted effect on
irreversible morbidity or mortality or other clinical benefit
has not been verified.
``(C) Rule of construction.--With respect to any
application pending before the Secretary on the date of
enactment of the Food and Drug Amendments of 2022, the
Secretary shall allow any applicable changes to the product
labeling required to comply with subparagraph (A) to be made
by supplement after the approval of such application.
``(5) Reporting.--Not later than September 30, 2025, 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 report
describing circumstances in which the Secretary considered
real world evidence submitted to support postapproval studies
required under this subsection that were completed after the
date of enactment of the Food and Drug Amendments of 2022.''.
(b) Reports of Postmarketing Studies.--Section 506B(a) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356b(a))
is amended--
(1) by redesignating paragraph (2) as paragraph (3); and
(2) by inserting after paragraph (1) the following:
``(2) Accelerated approval.--Notwithstanding paragraph (1),
a sponsor of a drug approved under accelerated approval shall
submit to the Secretary a report of the progress of any study
required under section 506(c), including progress toward
enrollment targets, milestones, and other information as
required by the Secretary, not later than 180 days after the
approval of such drug and not less frequently than every 180
days thereafter, until the study is completed or
terminated.''.
(c) Guidance.--
(1) In general.--The Secretary of Health and Human Services
shall issue guidance describing--
(A) how sponsor questions related to the identification of
novel surrogate or intermediate clinical endpoints may be
addressed in early-stage development meetings with the Food
and Drug Administration;
(B) the use of novel clinical trial designs that may be
used to conduct appropriate postapproval studies as may be
required under section 506(c)(2)(A) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356(c)(2)(A)), as amended
by subsection (a); and
(C) the expedited procedures described in section
506(c)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356(c)(3)(B)).
(2) Final guidance.--The Secretary shall issue--
(A) draft guidance under paragraph (1) not later than 18
months after the date of enactment of this Act; and
(B) final guidance not later than 1 year after the close of
the public comment period on such draft guidance.
(d) Rare Disease Endpoint Advancement Pilot.--
(1) In general.--The Secretary of Health and Human Services
shall establish a pilot program under which the Secretary
will establish procedures to provide increased interaction
with sponsors of rare disease drug development programs for
purposes of advancing the development of efficacy endpoints,
including surrogate and intermediate endpoints, for drugs
intended to treat rare diseases, including through--
(A) determining eligibility of participants for such a
program; and
(B) developing and implementing a process for applying to,
and participating in, such a program.
(2) Public workshops.--The Secretary shall conduct up to 3
public workshops, which shall be completed not later than
September 30, 2026, to discuss topics relevant to the
development of endpoints for rare diseases, which may include
discussions about--
(A) novel endpoints developed through the pilot program
established under this subsection; and
(B) as appropriate, the use of real world evidence and real
world data to support the validation of efficacy endpoints,
including surrogate and intermediate endpoints, for rare
diseases.
(3) Report.--Not later than September 30, 2027, 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 report
describing the outcomes of the pilot program established
under this subsection.
(4) Guidance.--Not later than September 30, 2027, the
Secretary shall issue guidance describing best practices and
strategies for development of efficacy endpoints, including
surrogate and intermediate endpoints, for rare diseases.
(5) Sunset.--The Secretary may not accept any new
application or request to participate in the program
established by this subsection on or after October 1, 2027.
SEC. 805. FACILITATING THE USE OF REAL WORLD EVIDENCE.
(a) Guidance.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human
Services shall issue, or revise existing, guidance on
considerations for the use of real world data and real world
evidence to support regulatory decisionmaking, as follows:
(1) With respect to drugs, such guidance shall address--
(A) the use of such data and evidence to support the
approval of a drug application under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or a
biological product application under section 351 of the
Public Health Service Act (42 U.S.C. 262), or to support an
investigational use exemption under section 505(i) of the
Federal Food, Drug, and Cosmetic Act or section 351(a)(3) of
the Public Health Service Act; and
(B) the use of such data and evidence obtained as a result
of the use of drugs authorized for emergency use under
section 564 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-3) in such applications, submissions, or
requests; and
(C) standards and methodologies which may be used for
collection and analysis of real world evidence included in
such applications, submissions, or requests, as appropriate.
(2) With respect to devices, such guidance shall address--
[[Page H5317]]
(A) the use of such data and evidence to support the
approval, clearance, or classification of a device pursuant
to an application or submission submitted under section
510(k), 513(f)(2), or 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(k), 360c(f)(2), 360e), or to
support an investigational use exemption under section 520(g)
of such Act (21 U.S.C. 360j(g));
(B) the use of such data and evidence obtained as a result
of the use of devices authorized for emergency use under
section 564 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-3), in such applications, submissions, or
requests; and
(C) standards and methodologies which may be used for
collection and analysis of real world evidence included in
such applications, submissions, or requests, as appropriate.
(b) Report to Congress.--Not later than 2 years after the
termination of the public health emergency determination by
the Secretary of Health and Human Services under section 564
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-3) on February 4, 2020, with respect to the
Coronavirus Disease 2019 (COVID-19), the Secretary shall
submit a report to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate on--
(1) the number of applications, submissions, or requests
submitted for clearance or approval under section 505,
510(k), 513(f)(2), or 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355, 360(k), 360c(f)(2), 360e) or
section 351 of the Public Health Service Act, for which an
authorization under section 564 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-3) was previously granted;
(2) of the number of applications so submitted, the number
of such applications--
(A) for which real world evidence was submitted and used to
support a regulatory decision; and
(B) for which real world evidence was submitted and
determined to be insufficient to support a regulatory
decision; and
(3) a summary explanation of why, in the case of
applications described in paragraph (2)(B), real world
evidence could not be used to support regulatory decisions.
(c) Information Disclosure.--Nothing in this section shall
be construed to authorize the disclosure of information that
is prohibited from disclosure under section 1905 of title 18,
United States Code, or subject to withholding under
subsection (b)(4) of section 552 of title 5, United States
Code (commonly referred to as the ``Freedom of Information
Act'').
SEC. 806. DUAL SUBMISSION FOR CERTAIN DEVICES.
Section 513 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360c) is amended by adding at the end the following:
``(k) For a device authorized for emergency use under
section 564 for which, in accordance with section 564(m), the
Secretary has deemed a laboratory examination or procedure
associated with such device to be in the category of
examinations and procedures described in section 353(d)(3) of
the Public Health Service Act, the sponsor of such device
may, when submitting a request for classification under
section 513(f)(2), submit a single submission containing--
``(1) the information needed for such a request; and
``(2) sufficient information to enable the Secretary to
determine whether such laboratory examination or procedure
satisfies the criteria to be categorized under section
353(d)(3) of the Public Health Service Act.''.
SEC. 807. MEDICAL DEVICES ADVISORY COMMITTEE MEETINGS.
(a) In General.--The Secretary shall convene one or more
panels of the Medical Devices Advisory Committee not less
than once per year for the purpose of providing advice to the
Secretary on topics related to medical devices used in
pandemic preparedness and response, including topics related
to in vitro diagnostics.
(b) Required Panel Member.--A panel convened under
subsection (a) shall include at least 1 population health-
specific representative.
(c) Sunset.--This section shall cease to be effective on
October 1, 2027.
SEC. 808. ENSURING CYBERSECURITY OF MEDICAL DEVICES.
(a) In General.--Subchapter A of chapter V of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as
amended by section 501, is further amended by adding at the
end the following:
``SEC. 524C. ENSURING CYBERSECURITY OF DEVICES.
``(a) In General.--For purposes of ensuring cybersecurity
throughout the lifecycle of a cyber device, any person who
submits a premarket submission for the cyber device shall
include such information as the Secretary may require to
ensure that the cyber device meets such cybersecurity
requirements as the Secretary determines to be appropriate to
demonstrate a reasonable assurance of safety and
effectiveness, including at a minimum the cybersecurity
requirements under subsection (b).
``(b) Cybersecurity Requirements.--At a minimum, the
manufacturer of a cyber device shall meet the following
cybersecurity requirements:
``(1) The manufacturer shall have a plan to appropriately
monitor, identify, and address in a reasonable time
postmarket cybersecurity vulnerabilities and exploits,
including coordinated vulnerability disclosure and
procedures.
``(2) The manufacturer shall design, develop, and maintain
processes and procedures to ensure the device and related
systems are cybersecure, and shall make available updates and
patches to the cyber device and related systems throughout
the lifecycle of the cyber device to address--
``(A) on a reasonably justified regular cycle, known
unacceptable vulnerabilities; and
``(B) as soon as possible out of cycle, critical
vulnerabilities that could cause uncontrolled risks.
``(3) The manufacturer shall provide in the labeling of the
cyber device a software bill of materials, including
commercial, open-source, and off-the-shelf software
components.
``(4) The manufacturer shall comply with such other
requirements as the Secretary may require to demonstrate
reasonable assurance of the safety and effectiveness of the
device for purposes of cybersecurity, which the Secretary may
require by an order published in the Federal Register.
``(c) Substantial Equivalence.--In making a determination
of substantial equivalence under section 513(i) for a cyber
device, the Secretary may--
``(1) find that cybersecurity information for the cyber
device described in the relevant premarket submission in the
cyber device's use environment is inadequate; and
``(2) issue a nonsubstantial equivalence determination
based on this finding.
``(d) Definition.--In this section:
``(1) Cyber device.--The term `cyber device' means a device
that--
``(A) includes software, including software as or in a
device;
``(B) has the ability to connect to the internet; or
``(C) contains any such technological characteristics that
could be vulnerable to cybersecurity threats.
``(2) Lifecycle of the cyber device.--The term `lifecycle
of the cyber device' includes the postmarket lifecycle of the
cyber device.
``(3) Premarket submission.--The term `premarket
submission' means any submission under section 510(k), 513,
515(c), 515(f), or 520(m).
``(e) Exemption.--The Secretary may identify devices or
types of devices that are exempt from meeting the
cybersecurity requirements established by this section and
regulations promulgated pursuant to this section. The
Secretary shall publish in the Federal Register, and update,
as appropriate, a list of the devices and types of devices so
identified by the Secretary.''.
(b) Prohibited Act.--Section 301(q) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(q)) is amended by
adding at the end the following:
``(3) The failure to comply with any requirement under
section 524C (relating to ensuring device cybersecurity).''.
(c) Adulteration.--Section 501 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 351) is amended by inserting
after paragraph (j) the following:
``(k) If it is a device subject to the requirements set
forth in section 524C (relating to ensuring device
cybersecurity) and fails to comply with any requirement under
that section.''.
(d) Misbranding.--Section 502(t) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352(t)) is amended--
(1) by striking ``or (3)'' and inserting ``(3)''; and
(2) by inserting before the period at the end the
following: ``, or (4) to furnish a software bill of materials
as required under section 524C (relating to ensuring device
cybersecurity)''.
SEC. 809. PUBLIC DOCKET ON PROPOSED CHANGES TO THIRD-PARTY
VENDORS.
(a) In General.--
(1) Opening public docket.--Not later than 90 days after
the date of enactment of this Act, the Secretary of Health
and Human Services shall open a single public docket to
solicit comments on factors that generally should be
considered by the Secretary when reviewing requests from
sponsors of drugs subject to risk evaluation and mitigation
strategies to change third-party vendors engaged by sponsors
to aid in implementation and management of the strategies.
(2) Factors.--Such factors include the potential effects of
changes in third-party vendors on--
(A) patient access; and
(B) prescribing and administration of the drugs by health
care providers.
(3) Closing public docket.--The Secretary of Health and
Human Services may close such public docket not earlier than
90 days after such docket is opened.
(4) No delay.--Nothing in this section shall delay agency
action on any modification to a risk evaluation and
mitigation strategy.
(b) GAO Report.--Not later than December 31, 2026, 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 on--
(1) the number of changes in third-party vendors (engaged
by sponsors to aid implementation and management of risk
evaluation and mitigation strategies) for an approved risk
evaluation and mitigation strategy the Secretary of Health
and Human Services has approved under section 505-1(h)
[[Page H5318]]
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-
1(h));
(2) any issues affecting patient access to the drug that is
subject to the strategy or considerations with respect to the
administration or prescribing of such drug by health care
providers that arose as a result of such modifications; and
(3) how such issues were resolved, as applicable.
SEC. 810. FACILITATING EXCHANGE OF PRODUCT INFORMATION PRIOR
TO APPROVAL.
(a) In General.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended--
(1) in paragraph (a)--
(A) by striking ``drugs for coverage'' and inserting
``drugs or devices for coverage''; and
(B) by striking ``drug'' each place it appears and
inserting ``drug or device'', respectively;
(2) in paragraphs (a)(1) and (a)(2)(B), by striking ``under
section 505 or under section 351 of the Public Health Service
Act'' and inserting ``under section 505, 510(k), 513(f)(2),
or 515 of this Act or section 351 of the Public Health
Service Act'';
(3) in paragraph (a)(1)--
(A) by striking ``under section 505 or under section 351(a)
of the Public Health Service Act'' and inserting ``under
section 505, 510(k), 513(f)(2), or 515 of this Act or section
351 of the Public Health Service Act''; and
(B) by striking ``in section 505(a) or in subsections (a)
and (k) of section 351 of the Public Health Service Act'' and
inserting ``in section 505, 510(k), 513(f)(2), or 515 of this
Act or section 351 of the Public Health Service Act''; and
(4) by adding at the end the following:
``(gg)(1) Unless its labeling bears adequate directions for
use in accordance with paragraph (f), except that (in
addition to drugs or devices that conform with exemptions
pursuant to such paragraph) no drug or device shall be deemed
to be misbranded under such paragraph through the provision
of product information to a payor, formulary committee, or
other similar entity with knowledge and expertise in the area
of health care economic analysis carrying out its
responsibilities for the selection of drugs or devices for
coverage or reimbursement if the product information relates
to an investigational drug or device or investigational use
of a drug or device that is approved, cleared, granted
marketing authorization, or licensed under section 505,
510(k), 513(f)(2), or 515 of this Act or section 351 of the
Public Health Service Act (as applicable), provided--
``(A) the product information includes--
``(i) a clear statement that the investigational drug or
device or investigational use of a drug or device has not
been approved, cleared, granted marketing authorization, or
licensed under section 505, 510(k), 513(f)(2), or 515 of this
Act or section 351 of the Public Health Service Act (as
applicable) and that the safety and effectiveness of the drug
or device or use has not been established;
``(ii) information related to the stage of development of
the drug or device involved, such as--
``(I) the status of any study or studies in which the
investigational drug or device or investigational use is
being investigated;
``(II) how the study or studies relate to the overall plan
for the development of the drug or device; and
``(III) whether an application, premarket notification, or
request for classification for the investigational drug or
device or investigational use has been submitted to the
Secretary and when such a submission is planned;
``(iii) in the case of information that includes factual
presentations of results from studies, which shall not be
selectively presented, a description of--
``(I) all material aspects of study design, methodology,
and results; and
``(II) all material limitations related to the study
design, methodology, and results;
``(iv) where applicable, a prominent statement disclosing
the indication or indications for which the Secretary has
approved, granted marketing authorization, cleared, or
licensed the product pursuant to section 505, 510(k),
513(f)(2), or 515 of this Act or section 351 of the Public
Health Service Act, and a copy of the most current required
labeling; and
``(v) updated information, if previously communicated
information becomes materially outdated as a result of
significant changes or as a result of new information
regarding the product or its review status; and
``(B) the product information does not include--
``(i) information that represents that an unapproved
product--
``(I) has been approved, cleared, granted marketing
authorization, or licensed under section 505, 510(k),
513(f)(2), or 515 of this Act or section 351 of the Public
Health Service Act (as applicable); or
``(II) has otherwise been determined to be safe or
effective for the purpose or purposes for which the drug or
device is being studied; or
``(ii) information that represents that an unapproved use
of a drug or device that has been so approved, granted
marketing authorization, cleared, or licensed--
``(I) is so approved, granted marketing authorization,
cleared, or licensed; or
``(II) that the product is safe or effective for the use or
uses for which the drug or device is being studied.
``(2) For purposes of this paragraph, the term `product
information' includes--
``(A) information describing the drug or device (such as
drug class, device description, and features);
``(B) information about the indication or indications being
investigated;
``(C) the anticipated timeline for a possible approval,
clearance, marketing authorization, or licensure pursuant to
section 505, 510(k), 513, or 515 of this Act or section 351
of the Public Health Service Act;
``(D) drug or device pricing information;
``(E) patient utilization projections;
``(F) product-related programs or services; and
``(G) factual presentations of results from studies that do
not characterize or make conclusions regarding safety or
efficacy.''.
(b) GAO Study and Report.--Beginning on the date that is 5
years and 6 months after the date of enactment of this Act,
the Comptroller General of the United States shall conduct a
study on the provision and use of information pursuant to
section 502(gg) of the Federal Food, Drug, and Cosmetic Act,
as added by this subsection (a), between manufacturers of
drugs and devices (as defined in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321)) and entities
described in such section 502(gg). Such study shall include
an analysis of the following:
(1) The types of information communicated between such
manufacturers and payors.
(2) The manner of communication between such manufacturers
and payors.
(3)(A) Whether such manufacturers file an application for
approval, marketing authorization, clearance, or licensing of
a new drug or device or the new use of a drug or device that
is the subject of communication between such manufacturers
and payors under section 502(gg) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a).
(B) How frequently the Food and Drug Administration
approves, grants marketing authorization, clears, or licenses
the new drug or device or new use.
(C) The timeframe between the initial communications
permitted under section 502(gg) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), regarding an
investigational drug or device or investigational use, and
the initial marketing of such drug or device.
SEC. 811. BANS OF DEVICES FOR ONE OR MORE INTENDED USES.
(a) In General.--Section 516(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360f(a)) is amended--
(1) in paragraph (1), by inserting ``for one or more
intended use'' before the semicolon at the end; and
(2) in the matter following paragraph (2), by inserting
``for any such intended use or uses. A device that is banned
for one or more intended uses is not a legally marketed
device under section 1006 when intended for such use or
uses'' after ``banned device''.
(b) Specific Devices Deemed Banned.--Section 516 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360f) is
further amended by adding at the end the following:
``(c) Specific Device Banned.--Electrical stimulation
devices that apply a noxious electrical stimulus to a
person's skin intended to reduce or cease self-injurious
behavior or aggressive behavior are deemed to be banned
devices, as described in subsection (a).
``(d) Reversal by Regulation.--Devices banned under this
section are banned devices unless or until the Secretary
promulgates a regulation to make such devices or use of such
devices no longer banned based on a finding that such devices
or use of such devices does not present substantial deception
or an unreasonable and substantial risk of illness or injury,
or that such risk can be corrected or eliminated by
labeling.''.
SEC. 812. CLARIFYING APPLICATION OF EXCLUSIVE APPROVAL,
CERTIFICATION, OR LICENSURE FOR DRUGS
DESIGNATED FOR RARE DISEASES OR CONDITIONS.
(a) Application of Exclusive Approval, Certification, or
Licensure for Drugs Designated for Rare Diseases or
Conditions.--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 indication or use 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
indication or use for which the Secretary has approved or
licensed such drug''; and
(B) in paragraph (1), by striking ``with the disease or
condition for which the drug was designated'' and inserting
``for whom the drug is indicated''; and
(3) in subsection (c), by striking ``same rare disease or
condition'' and inserting ``same indication or use''.
(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. 813. GAO REPORT ON THIRD-PARTY REVIEW.
Not later than September 30, 2026, the Comptroller General
of the United States
[[Page H5319]]
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
third-party review program described in section 523 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m). Such
report shall include--
(1) a description of the financial and staffing resources
used to carry out such program;
(2) a description of actions taken by the Secretary
pursuant section 523(b)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360m(b)(2)(C)); and
(3) the results of an audit of the performance of select
persons accredited under such program.
SEC. 814. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND
PRIORITY REVIEW APPLICATIONS.
Section 807 of the FDA Reauthorization Act of 2017 (Public
Law 115-52) is amended, in the matter preceding paragraph
(1), by striking ``2022'' and inserting ``2027''.
SEC. 815. FDA WORKFORCE IMPROVEMENTS.
Section 714A of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379d-3a) is amended--
(1) in subsection (a), by striking ``medical products'' and
inserting ``products regulated by the Food and Drug
Administration''; and
(2) by striking subsection (d) and inserting the following:
``(d) Agency-wide Strategic Workforce Plan.--
``(1) In general.--Not later than 1 year after the date of
enactment of the Food and Drug Amendments of 2022, the
Commissioner of Food and Drugs shall develop and begin
implementation of an agency-wide strategic workforce plan at
the Food and Drug Administration, which shall include--
``(A) agency-wide human capital goals and strategies;
``(B) performance measures, benchmarks, or other elements
to facilitate the monitoring and evaluation of the progress
made toward such goals and the effectiveness of such
strategies; and
``(C) a process for updating such plan based on timely and
relevant information on an ongoing basis.
``(2) Report to congress.--Not later than 18 months after
the date of enactment of the Food and Drug Amendments of
2022, 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 report describing the plan under paragraph (1) and
the status of its implementation.''.
TITLE IX--MISCELLANEOUS
SEC. 901. DETERMINATION OF BUDGETARY EFFECTS.
The budgetary effects of this Act, for the purpose of
complying with the Statutory Pay-As-You-Go Act of 2010, shall
be determined by reference to the latest statement titled
``Budgetary Effects of PAYGO Legislation'' for this Act,
submitted for printing in the Congressional Record by the
Chairman of the House Budget Committee, provided that such
statement has been submitted prior to the vote on passage.
SEC. 902. MEDICAID IMPROVEMENT FUND.
Section 1941(b)(3)(A) of the Social Security Act (42 U.S.C.
1396w-1(b)(3)(A)) is amended by striking ``$0'' and inserting
``$450,000,000''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New
Jersey (Mr. Pallone) and the gentleman from Kentucky (Mr. Guthrie) each
will control 20 minutes.
The Chair recognizes the gentleman from New Jersey.
General Leave
Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material on H.R. 7667.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from New Jersey?
There was no objection.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in strong support of the Food and Drug
Amendments of 2022, a bill that recently passed out of the Energy and
Commerce Committee with unanimous support. This bill will provide the
FDA the funding it needs to ensure drugs and devices are safe and
effective. It also promotes development of new medical products to
treat every American, reduces the cost of prescription drugs, and
strengthens program integrity at the agency.
Primarily, the user fee reauthorization's main purpose is to give the
agency funding to conduct product reviews, facilitate the development
of new products to treat rare diseases, inspect facilities to ensure
they are compliant, and monitor medical products on the market for
continued safety and effectiveness.
It is essential that the House pass this legislation today because
funding that comes from these user fees expires in September. At
hearings earlier this year, senior FDA officials told us that failure
to pass this legislation well before the September deadline could be
catastrophic to the agency's operations and, more importantly, could
limit our ability to get patients the medical products that they and
their doctors rely on.
Mr. Speaker, I am very pleased that in addition to coming together to
reauthorize this funding, we have worked across the aisle to come to
agreement on a wide-ranging package of programs to improve biomedical
research and development, give FDA more tools to conduct quality
inspections, improve the medical product supply chain, improve generic
drug competition and access, and bring greater transparency and program
integrity to FDA's operations.
While I do not have time to discuss all the provisions in the Food
and Drug Amendments of 2022, I want to highlight a few.
First, the bill includes reforms to the accelerated approval program,
which I first introduced in Congress earlier this year. Under the
accelerated approval pathway, drugs may be approved based on a
surrogate endpoint, such as an improved lab measurement or
visualization on an MRI, even though additional evidence is still
needed to show a clear clinical benefit for the patient. If a drug is
approved under this pathway, the sponsor must conduct studies after the
product is on the market to show that the drug actually provides a
benefit to patients. This approval pathway has led to patients having
access to groundbreaking treatments for cancer, HIV, and other
illnesses faster than they otherwise would have.
However, in recent years, it has become clear that some drug sponsors
have failed to conduct their post-approval studies in a timely manner,
while others have conducted studies that indicate that the drug is not
effective but are able to keep the product on the market for years
afterwards.
Patients deserve to know the drugs they are taking are safe and
effective. Food and Drug Amendments of 2022 ensures that the products
patients are taking are providing a benefit by allowing FDA to require
that sponsors begin adequate and well-controlled post-approval studies
before the drug goes on the market. The legislation will provide
greater transparency in drug labeling, and it streamlines the process
for FDA to remove products from the market when the sponsors have
failed to act with due diligence to conduct studies or where studies
have failed to show a benefit to patients.
The second thing is, this legislation ensures that clinical trials
for drugs and medical devices are representative of the people who will
use the products. The lack of diversity in clinical trials is an urgent
problem. It compromises our ability to understand how drugs and
diseases affect populations differently, compounds health disparities,
and can hinder innovation and add cost burdens into the health system.
Food and Drug Amendments of 2022 for the first time will require drug
and device sponsors to develop a clinical trial diversity action plan
early in the development process and submit the plan to FDA. This will
help improve our understanding of these products and lead to better
outcomes for all Americans.
Food and Drug Amendments of 2022 will also help lower drug costs by
making it easier for generic products to come to market. Under current
law, generic drug sponsors sometimes need to play a guessing game of
the ingredients in brand drugs, and this can add months on to the
generic drug development process. Under Food and Drug Amendments of
2022, we are making it easier for FDA to communicate this information
to drug sponsors, thereby speeding up development times for generics.
The bill will also make it easier for generics to come to market when a
brand drug changes its label at the last second in an attempt to limit
competition. Together, these provisions will produce millions of
dollars in savings for American families and the overall healthcare
system.
This legislation also takes concrete action to address the infant
formula crisis American families are currently facing, and which we are
so concerned about, and will prevent future problems related to food
safety and supply, so it's not just about infant formula, but about
food safety in general.
Currently, FDA is operating its food safety and other divisions with
one
[[Page H5320]]
hand tied behind its back when it comes to hiring and retaining highly
qualified scientific and regulatory staff. Today, FDA can hire
technical staff in its drug and medical device centers under
streamlined processes and compete with the private sector in terms of
salary, but those same flexibilities do not extend to other centers,
including those overseeing food at the FDA. Our bill would extend these
to the oversight of food, tobacco, and other products regulated by the
agency. While we must do more in this area, I am pleased that we are
able to move forward on a bipartisan basis here today. I think it is
going to make a difference, Mr. Speaker, not only with infant formula
but with so many other food products.
Lastly, Mr. Speaker, I thank my colleagues on the Energy and Commerce
Committee for their cooperation and bipartisan work on this package. As
I said, it passed unanimously out of the committee last month, thanks
to the leadership of Health Subcommittee Chairwoman Eshoo, Ranking
Member Guthrie, and the full committee Ranking Member Rodgers.
When you bring a bill to the floor on suspension and it is
bipartisan, and it was voted out of committee unanimously, it might
kind of belie the amount of work that the staff who are here with me
today and others put into this. This was a lot of work. It wasn't easy
to get it done in a timely fashion, even though it has unanimous
support. I hope today everyone will vote for it; I do not want anyone
to get the impression that this was not an easy thing to accomplish
because it certainly was.
Mr. Speaker, I encourage all Members to support this bill, and I
reserve the balance of my time.
Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of the Food and Drug Amendments
of 2022, introduced by Chair Eshoo and myself. This legislation
recently passed the full Energy and Commerce Committee unanimously.
The bill will protect access to lifesaving cures, promote innovation,
secure our medical supply chains, and lower costs for patients. It
would also reauthorize the Food and Drug Administration's medical
product user fee programs through 2027.
User fees allow the FDA to collect fees from industry in exchange for
timely review of their drug or device applications. Importantly, these
fees not only permit the FDA to carry out drug or device application
reviews, but they also represent significant percentages of FDA's total
operating budget without costing the taxpayer.
Additionally, according to the Congressional Budget Office, sections
of the bill will save close to $600 million by promoting increased
access to generic drugs. Some of these savings will be used for deficit
reduction and other amounts can be put toward preserving access to
critical services in the Medicaid program, such as telehealth.
Not only do these agreements help save taxpayer dollars, but they
also yield significant returns on investment since they were originally
authorized by Congress decades ago. For example, in 2021 alone, 38 of
50 of the world's novel drugs were first approved in the United States.
This was made possible by the Food and Drug Administration Amendments
of 2017.
I am proud to say that the legislation includes two of my bills, the
Pre-approval Information Exchange Act, which will help reduce the time
in which patients wait for a drug or a device to be covered by the
insurer after it is approved by the FDA.
The bill before us today also includes legislation that Chair Pallone
and I have been championing for several years to help facilitate the
transformation of drug manufacturing processes, so they are more
efficient, less costly, and result in improved drug quality. The use of
continuous manufacturing technology will not only serve as an incentive
for U.S. drug manufacturers to bring their production back to American
soil but will also help reduce drug shortages.
Other important components of the Food and Drug Amendments of 2022
require guidance on the collection of real-world evidence for companies
with products authorized under emergency use authorization during the
COVID-19 public health emergency. This can serve as a strong foundation
for the regulatory community in addition to drug or device companies to
best understand how products can get approved more quickly and safely
in the future.
Finally, the Food and Drug Amendments of 2022 preserves access to
lifesaving therapies approved under the accelerated approval pathway.
By preserving the pathway, we are giving patients hope to one day find
cures to currently incurable diseases, such as Alzheimer's disease or
terminal cancers.
As the Chair said, usually when you come to the floor on suspension
bills, they are ones that have great unanimous consent with Congress.
This has gone through the regular process, and it has gone through a
lot of hard work by Members, but I have to say a lot of hard work,
significant hard work, by the men and women who work with us here on
the committee. We really appreciate the staff's hard work.
Although we are here in a suspension moment on the floor, I emphasize
to my colleagues, there has been a lot of work, a lot of committee
work, a lot of subcommittee work, a lot of Member work, and a whole lot
of staff work to make this move forward. I really appreciate that.
Mr. Speaker, I urge my colleagues to support this legislation today,
and I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I have no additional speakers at this time.
I continue to reserve the balance of my time.
Mr. GUTHRIE. Mr. Speaker, I yield 3 minutes to the gentleman from
Indiana (Mr. Bucshon).
Mr. BUCSHON. Mr. Speaker, I rise today in support of the bipartisan
Food and Drug Amendments of 2022.
This is an important reauthorization that is necessary to help drive
innovation and make sure patients have continued access to critical
treatments and cures.
I am pleased to see the continued focus on innovation this agreement
brings, as well as its included policies like the DIVERSE Trials Act,
which I helped author, which will help increase diverse participation
in clinical trials.
More can be done to protect patients. One example being diagnostic
testing, specifically lab-developed tests.
For well over 5 years, I have been working on the bipartisan VALID
Act, H.R. 4128, with my colleague Diana DeGette, which establishes a
risk-based regulatory framework for diagnostic and laboratory-developed
tests.
This legislation allows for leading-edge development and innovation
to thrive while assuring doctors and patients have the certainty that
their test results are analytically and clinically valid. The draft
version of the user fee agreements introduced in the Senate addresses
the issue by including a version of the VALID Act.
Mr. Speaker, I again express my strong support for the Food and Drug
Amendments Act of 2022, and I urge my colleagues to vote ``yes'' on
this legislation.
{time} 1830
Mr. PALLONE. Mr. Speaker, I reserve the balance of my time.
Mr. GUTHRIE. Mr. Speaker, I was incorrect. I said Mr. Bucshon. Dr.
Bucshon; his words on healthcare are certainly very important to all of
us.
Mr. Speaker, I yield 4 minutes to the gentlewoman from Washington
(Mrs. Rodgers), my good friend, the Republican leader of the full
Committee on Energy and Commerce.
Mrs. RODGERS of Washington. Mr. Speaker, I rise today in support of
H.R. 7667, the Food and Drug Amendments Act.
The Committee on Energy and Commerce plowed the hard ground necessary
to legislate in a strong bipartisan way on this bill. We held three
hearings in the Subcommittee on Health in February and March. In April,
we introduced legislation, and then over the next week, the
subcommittee voted.
H.R. 7667 passed out of Committee on Energy and Commerce by a vote of
55-0, and at each step, members' ideas were included to improve the
legislation.
Today, we consider a suspension print with further improvements. It
adds another provision for more drug manufacturing in America by
providing the regulatory clarity needed
[[Page H5321]]
and the training necessary to utilize novel manufacturing technologies.
Overall, the FDA Act will reauthorize four user fee programs created
to expedite the review of critical medical products that people depend
on to live healthier and longer lives.
In addition to delivering drugs and medical devices to people faster,
the FDA Act includes policies to lower healthcare costs, spur more
lifesaving innovation, secure our supply chains, and provide hope to
patients in need of breakthrough drugs and therapies. Those treatments
won't make it to patients if FDA doesn't have the right tools to keep
up with science, such as accelerated approval pathway.
Chairman Pallone and I initially had quite different versions for how
the accelerated approval process should be updated, but we focused on
where we could agree. We streamlined the process to remove drugs that
no longer show effectiveness in post-market studies and made sure that
real-world evidence can be used. We also made sure rare diseases aren't
left out of accelerated approval because of a lack of knowledge and
interest in developing the biomarkers necessary.
Lastly, not only is this legislation necessary to preserve patient
access to new medical breakthroughs, it is fiscally responsible. It
ensures FDA's timely review of medical products at a reduced cost to
the taxpayer, and it reduces the deficit.
Many other members have priorities included in this legislation.
Mr. Buchanan has a bipartisan bill to make sure that we are moving
away from preclinical testing on animal models where alternatives can
work just as well.
Messrs. Griffith, Carter, and Hudson all have legislation to hold FDA
accountable regarding inspections of foreign manufacturing facilities
and pilots for FDA to give companies with novel manufacturing
technologies more certainty.
Mr. Guthrie has a solution included to help insurers plan for
breakthrough future treatments. This will help patients avoid sticker
shock and protect earlier access to those treatments.
These are just some of more than a dozen examples of member
priorities in the FDA Act. I strongly urge support of this legislation,
and I encourage all of my colleagues to vote ``yes.''
Mr. Speaker, this is for patients and families in every district and
every corner of America who are relying on a generic drug, a medical
device, like a pacemaker, or a novel cancer treatment. Those patients
are relying on Congress to do its job so their drug approval isn't
stalled.
I think about all the advocates, the hundreds of disease and rare
disease groups who come to the people's House to share their stories
with us. They have an extraordinary amount of hope in the promise of
American innovation for new cures and access to treatments.
For them, I am supporting this legislation, and I am committed to
work to get this signed into law on time.
Mr. PALLONE. Madam Speaker, I am prepared to close, and I reserve the
balance of my time.
Mr. GUTHRIE. Madam Speaker, I yield myself such time as I may
consume.
Madam Speaker, through the years, since this medical device fee has
been put into place, has Congress taken action to make sure an agency
is efficient; that it does its job to make sure that our drugs and
medical devices have efficacy, but also are safe? So we make them more
efficient and we have drug companies, device companies, other
companies, generic companies, trying to get their devices or their
pharmaceuticals approved so they can bring them on the marketplace that
are safe and efficient. So this is really an example of Congress
working together to move this process forward.
And the innovations that have come out in the last few years, if we
look at what has gone on in the diabetes world with the artificial
pancreas, all the pumps and insulin devices, to hepatitis C,
pharmaceuticals and other ways, and just so much more, what is going to
happen in the next 5 years as we continue to move this process forward?
We had a hearing in the Subcommittee on Health on ALS, and we had an
ALS patient before us who just wants hope. So all of that is accounted
for in this process.
We, as Members of Congress, we, as members of the Committee on Energy
and Commerce have worked together to make the process streamlined, to
make sure we have efficient, efficacy, and safe products. Our hope and
our prayers from this is the science will come into place so those who
testified before our committee with rare diseases will have the
opportunity and hope to be healed.
I urge my colleagues to support this piece of legislation. A lot of
hard work went into it. A lot of lives can be affected by it. I
encourage everyone to vote for it.
Madam Speaker, I yield back the balance of my time.
Mr. PALLONE. Madam Speaker, I yield myself such time as I may
consume.
Madam Speaker, I couldn't agree more with what Ranking Member Guthrie
said, and also our full committee ranking member, Mrs. Rodgers. This is
a product of a lot of hard work on behalf of members, as well as the
staff that are here, and others. It is really great that we are able to
do it in a timely fashion because we want the FDA to be able to
operate, not to have to put out pink slips because the authorization
expires in September.
This is really a reauthorization that does a lot more than just
reauthorize the current programs. It really is going to make a
difference in terms of our ability to innovate and also affect access
to generic drugs.
Madam Speaker, I encourage all Members to support the bill. We are
going to work hard to get this passed in the Senate in a timely
fashion.
Madam Speaker, I yield back the balance of my time.
The SPEAKER pro tempore (Ms. Pingree). The question is on the motion
offered by the gentleman from New Jersey (Mr. Pallone) that the House
suspend the rules and pass the bill, H.R. 7667, as amended.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. HARRIS. Madam Speaker, on that I demand the yeas and nays.
The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution
8, the yeas and nays are ordered.
Pursuant to clause 8 of rule XX, further proceedings on this motion
are postponed.
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