[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2683 Introduced in Senate (IS)]
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118th CONGRESS
1st Session
S. 2683
To establish requirements for purchasing certain generic drugs from
manufacturers who produce the drug domestically.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 27, 2023
Mr. Scott of Florida introduced the following bill; which was read
twice and referred to the Committee on Health, Education, Labor, and
Pensions
_______________________________________________________________________
A BILL
To establish requirements for purchasing certain generic drugs from
manufacturers who produce the drug domestically.
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 ``Accelerating Movement of Essential
Rx Items to Create Access to National Drug Resources for US Government
Services Act'' or the ``AMERICAN DRUGS Act''.
SEC. 2. FDA NOTIFICATION.
(a) In General.--The Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs (referred to in this section
as the ``Commissioner''), shall issue notifications to the
Administrator of the Centers for Medicare & Medicaid Services, the
Secretary of Defense, and the Secretary of Veterans Affairs upon a
determination by the Commissioner that--
(1) there are at least 2 approved generic drugs that are
manufactured domestically, as described in subsection (b), each
of which--
(A) is approved pursuant to an application under
section 505(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)); and
(B) references the same listed drug under paragraph
(7) of such section 505(j); or
(2) there are fewer than 2 approved generic drugs that are
manufactured domestically--
(A) approved pursuant to an application under
section 505(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)); and
(B) that reference the same listed drug under
paragraph (7) of such section 505(j) as another drug
approved under such section 505(j);
(3) paragraph (1)(B) may soon apply because the
Commissioner has been notified that a holder of an approved
application for a generic drug that is manufactured
domestically, as described in subsection (b), plans to
discontinue manufacturing, or expects an interruption of the
manufacture of, such drug at an establishment described in
subsection (b)(1)(B); or
(4) a generic drug that is manufactured domestically, as
described in subsection (b), is in shortage, as defined in
section 506C(h)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 356c(h)(2)).
(b) Generic Drug Manufactured Domestically Described.--In this
section, a generic drug that is manufactured domestically--
(1) is a drug--
(A) that is approved under section 505(j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)); and
(B) for which there is at least one establishment
registered under section 510(b)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360(b)(1)) engaged in
the manufacture of the finished dosage form of the
drug; and
(2) excludes any authorized generic drug, as defined in
section 505(t)(3) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(t)(3)).
(c) Special Rule Concerning Generic Drugs in Shortage.--A
notification under subsection (a)(4) that a generic drug that is
manufactured domestically, as described in subsection (b), is in
shortage, shall apply only for--
(1) an initial period of not more than 90 days; and
(2) such additional 30-day renewal periods as the Secretary
of Health and Human Services may indicate by--
(A) submitting to Congress a notification of intent
to renew the notification under subsection (a)(4); and
(B) publicly posting information about the
shortage, the steps the Food and Drug Administration is
taking to address the shortage, and an estimated date
by which the shortage is expected to be resolved.
SEC. 3. EXPEDITED CONSIDERATION OF CERTAIN ABBREVIATED NEW DRUG
APPLICATIONS.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
351 et seq.) is amended by inserting after section 506L the following:
``SEC. 506M. EXPEDITED CONSIDERATION OF CERTAIN ABBREVIATED NEW DRUG
APPLICATIONS.
``(a) In General.--The Secretary may, at the request of a sponsor
of an application for an applicable drug, expedite the development and
review of an abbreviated new drug application under section 505(j) for
such drug.
``(b) Applicable Drug.--For purposes of this section, an applicable
drug is a drug for which there are fewer than 2 drugs approved under
section 505(j) that are manufactured domestically, as described in
paragraph (2), each of which is approved pursuant to an application
under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) and references the same listed drug under paragraph (7)
of such section 505(j).
``(c) Actions.--In expediting the development and review of an
application under subsection (a), the Secretary may, as requested by
the applicant, take actions including the following:
``(1) Hold meetings with the applicant and the review team
throughout the development of the drug prior to submission of
the application for such drug under section 505(j).
``(2) Provide timely advice to, and interactive
communication with, the applicant regarding the development of
the drug to ensure that the development program to gather the
data necessary for approval is as efficient as practicable.
``(3) Involve senior managers and experienced review staff,
as appropriate, in a collaborative, coordinated review of such
application, including with respect to drug-device combination
products and other complex products.
``(4) Assign a cross-disciplinary project lead--
``(A) to facilitate an efficient review of the
development program and application, including
manufacturing inspections; and
``(B) to serve as a scientific liaison between the
review team and the applicant.
``(d) Reporting Requirement.--Not later than one year after the
date of the approval of an application under section 505(j) with
respect to a drug for which the development and review is expedited
under this section, the sponsor of such drug shall report to the
Secretary on whether the drug has been marketed in interstate commerce
since the date of such approval.''.
SEC. 4. PROHIBITION OF PAYMENT UNDER MEDICARE PART B OR COVERAGE UNDER
MEDICARE PART D FOR CERTAIN GENERIC DRUGS MANUFACTURED
OUTSIDE OF THE UNITED STATES.
(a) Medicare Part B.--Section 1842(o) of the Social Security Act
(42 U.S.C. 1395u(o)) is amended by adding at the end the following new
paragraph:
``(9)(A) Payment shall only be made under this part for a generic
drug furnished on or after January 1, 2025, if it is a generic drug
manufactured domestically (as described in section 2(b) of the
Accelerating Movement of Essential Rx Items to Create Access to
National Drug Resources for US Government Services Act).
``(B) Subparagraph (A) shall not apply, with respect to a drug,
during any period for which the Secretary--
``(i) has notified the Administrator of the Centers for
Medicare & Medicaid Services pursuant to section 2(a) of the
Accelerating Movement of Essential Rx Items to Create Access to
National Drug Resources for US Government Services Act that the
circumstances under paragraph (2), (3), or (4) of such section
apply; or
``(ii) otherwise determines that access to the drug is
essential to the health of beneficiaries under this part.''.
(b) Medicare Part D.--Section 1860D-42 of the Social Security Act
(42 U.S.C. 1395w-152) is amended by adding at the end the following new
subsection:
``(e) Prohibition of Coverage for Certain Generic Drugs
Manufactured Outside of the United States.--
``(1) In general.--Coverage shall only be available under
this part for a covered part D drug that is a generic drug
dispensed on or after January 1, 2025, if it is a generic drug
manufactured domestically (as described in section 2(b) of the
Accelerating Movement of Essential Rx Items to Create Access to
National Drug Resources for US Government Services Act).
``(2) Exceptions.--Paragraph (1) shall not apply, with
respect to a covered part D drug, during any period for which
the Secretary--
``(A) has notified the Administrator of the Centers
for Medicare & Medicaid Services pursuant to section
2(a) of the Accelerating Movement of Essential Rx Items
to Create Access to National Drug Resources for US
Government Services Act that the circumstances under
paragraph (2), (3), or (4) of such section apply; or
``(B) otherwise determines that access to the drug
is essential to the health of beneficiaries under this
part.''.
SEC. 5. PROHIBITION OF PAYMENT UNDER MEDICAID AND CHIP FOR CERTAIN
GENERIC DRUGS MANUFACTURED OUTSIDE OF THE UNITED STATES.
(a) Medicaid.--Title XIX of the Social Security Act (42 U.S.C. 1396
et seq.) is amended--
(1) in section 1903(i)(10)--
(A) in subparagraph (D), by striking ``; and'' and
inserting a semicolon;
(B) in subparagraph (E), by striking ``; or'' and
inserting ``; and''; and
(C) by inserting after subparagraph (E) the
following new subparagraph:
``(F) with respect to any amount expended for a covered
outpatient drug which the State is required to exclude from
coverage under section 1927(d)(8); or''; and
(2) in section 1927(d), by adding at the end the following
new paragraph:
``(8) Restriction on coverage of foreign-made generic
drugs.--
``(A) In general.--Beginning January 1, 2025, a
State shall exclude coverage of a foreign-made generic
covered outpatient drug if there is a generic drug that
is manufactured domestically (as described in section
2(b) of the Accelerating Movement of Essential Rx Items
to Create Access to National Drug Resources for US
Government Services Act) that references the same
listed drug under section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act as the foreign-made
generic covered outpatient drug.
``(B) Definition of foreign-made generic covered
outpatient drug.--For purposes of this paragraph, the
term `foreign-made generic covered outpatient drug'
means a covered outpatient drug that--
``(i) is approved under section 505(j) of
the Federal Food, Drug, and Cosmetic Act; and
``(ii) is not a generic drug that is
manufactured domestically (as described in
section 2(b) of the Accelerating Movement of
Essential Rx Items to Create Access to National
Drug Resources for US Government Services Act).
``(C) Exceptions.--Subparagraph (A) shall not apply
to a foreign-made generic covered outpatient drug
during any period for which the Secretary--
``(i) has notified the Administrator of the
Centers for Medicare & Medicaid Services
pursuant to section 2(a) of the Accelerating
Movement of Essential Rx Items to Create Access
to National Drug Resources for US Government
Services Act that the circumstances under
paragraph (2), (3), or (4) of such section
apply with respect to such drug; or
``(ii) otherwise determines that access to
the foreign-made generic covered outpatient
drug is essential to the health of individuals
enrolled for medical assistance under this
title.
``(D) Notice to states.--The Secretary shall
provide notice to States if a foreign-made generic
covered outpatient drug is subject to exclusion from
coverage under this paragraph.''.
(b) CHIP.--Section 2107(e)(1)(M) of the Social Security Act (42
U.S.C. 1397gg(e)(1)(M)) is amended by inserting ``(10)(F),'' after
``(2),''.
SEC. 6. PROCUREMENT BY DEPARTMENT OF VETERANS AFFAIRS OF GENERIC DRUGS
MANUFACTURED DOMESTICALLY.
(a) In General.--Subchapter II of chapter 81 of title 38, United
States Code, is amended by inserting after section 8126 the following
new section:
``Sec. 8126A. Procurement of generic drugs manufactured domestically
``(a) In General.--Subject to subsection (b), the Secretary may
only procure a generic drug if it is a generic drug manufactured
domestically, as described in section 2(b) of the Accelerating Movement
of Essential Rx Items to Create Access to National Drug Resources for
US Government Services Act.
``(b) Exceptions.--Subsection (a) shall not apply with respect to a
drug during any period for which--
``(1) the Secretary of Health and Human Services has
notified the Secretary of Veterans Affairs pursuant to section
2(a) of the Accelerating Movement of Essential Rx Items to
Create Access to National Drug Resources for US Government
Services Act that the circumstances under paragraph (2), (3),
or (4) of such section apply; or
``(2) the Secretary of Veterans Affairs determines that
access to the drug is essential to the health of beneficiaries
under the laws administered by the Secretary.''.
(b) Clerical Amendment.--The table of sections at the beginning of
such subchapter is amended by inserting after the item relating to
section 8126 the following new item:
``8126A. Procurement of generic drugs manufactured domestically.''.
(c) Effective Date.--The amendments made by this section shall take
effect on January 1, 2025.
SEC. 7. PROCUREMENT BY DEPARTMENT OF DEFENSE OF GENERIC DRUGS
MANUFACTURED DOMESTICALLY.
(a) In General.--Chapter 55 of title 10, United States Code, is
amended by inserting after section 1074g the following new section:
``Sec. 1074g-1. Procurement of generic drugs manufactured domestically
``(a) In General.--Subject to subsection (b), the Secretary of
Defense may only procure a generic drug if it is a generic drug
manufactured domestically, as described in section 2(b) of the
Accelerating Movement of Essential Rx Items to Create Access to
National Drug Resources for US Government Services Act.
``(b) Exceptions.--Subsection (a) shall not apply with respect to a
drug during any period for which--
``(1) the Secretary of Health and Human Services has
notified the Secretary of Defense pursuant to section 2(a) of
the Accelerating Movement of Essential Rx Items to Create
Access to National Drug Resources for US Government Services
Act that the circumstances under paragraph (2), (3), or (4) of
such section apply; or
``(2) the Secretary of Defense determines that access to
the drug is essential to the health of beneficiaries under the
TRICARE program.''.
(b) Clerical Amendment.--The table of sections at the beginning of
such chapter is amended by inserting after the item relating to section
1074g the following new item:
``1074g-1. Procurement of generic drugs manufactured domestically.''.
(c) Effective Date.--The amendments made by this section shall take
effect on January 1, 2025.
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