[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5419 Introduced in Senate (IS)]
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118th CONGRESS
2d Session
S. 5419
To require the Secretary of Health and Human Services to maintain a
list of the country of origin of certain critical drugs marketed in the
United States, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 4, 2024
Mr. Cotton (for himself and Mr. Kaine) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To require the Secretary of Health and Human Services to maintain a
list of the country of origin of certain critical drugs marketed in the
United States, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Protecting Our Essential Medicines
Act''.
SEC. 2. LIST OF CRITICAL DRUGS PRODUCED OUTSIDE THE UNITED STATES.
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. 524C. LIST OF CRITICAL DRUGS PRODUCED OUTSIDE THE UNITED STATES.
``(a) List of Critical Drugs.--
``(1) In general.--For purposes of strengthening the public
health supply chain and industrial base, and increasing the
manufacture of essential drugs, including biological products,
and critical inputs of such drugs in the United States, the
Secretary shall compile and maintain a list of each drug that
is--
``(A) approved under subsection (c) or (j) of
section 505 of this Act or licensed under subsection
(a) or (k) of section 351 of the Public Health Service
Act;
``(B) imported into the United States; and
``(C)(i) determined by the interagency task force
established under subsection (e) to be critical to the
health and safety of consumers in the United States;
``(ii) determined by such task force to be a drug
the shortage of which would have an adverse health
outcome on patients with chronic conditions; or
``(iii) a qualified countermeasure, as defined in
section 319F-1(a)(2) of the Public Health Service Act,
a qualified pandemic or epidemic product, as defined in
section 319F-3(i) of such Act, or a security
countermeasure, as defined in section 319F-2(c) of such
Act.
``(2) Supply chain information.--The list required by
paragraph (1) shall, with respect to each drug included on the
list, provide information about each facility registered under
section 510 that is involved in the manufacture, preparation,
propagation, compounding, or processing of the drug or an
ingredient of the drug.
``(3) No public disclosure.--The list required by paragraph
(1), and any portion thereof, shall not be publicly disclosed,
and nothing in paragraph (1) or (2) shall be construed as
authorizing the Secretary 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.
``(4) Permissible disclosure to national security agencies
of the federal government.--The list required by paragraph (1)
(and any portion thereof) may be disclosed by the Secretary
only--
``(A) within the Department of Health and Human
Services and pursuant to reporting under subsection
(e); and
``(B) for purposes of evaluating supply chain
vulnerabilities and other national security issues,
with national security agencies of the Federal
Government, including all elements of the Department of
Defense and national intelligence agencies.
``(5) Definition.--In this subsection, the term `critical
inputs' means active pharmaceutical ingredients, starting
material for active pharmaceutical ingredients, and other
ingredients of drugs that the Commissioner of Food and Drugs
determines to be critical in assessing the safety and
effectiveness of drugs described in paragraph (1).
``(b) Additional Lists.--
``(1) In general.--In conjunction with the list under
subsection (a), the Secretary shall, in consultation with the
interagency task force established under subsection (e),
compile and maintain--
``(A) a list of drugs included on the list under
subsection (a) that are exclusively produced in, or use
active pharmaceutical ingredients produced in, a
foreign entity of concern (as defined in section
9901(8) of the William M. (Mac) Thornberry National
Defense Authorization Act for Fiscal Year 2021); and
``(B) a list identifying the top 3 countries from
which the United States imports drugs described in
subsection (a)(1).
``(2) Disclosure.--
``(A) List of drugs.--
``(i) No public disclosure.--The list
required by paragraph (1)(A) (and any portion
thereof) shall not be publicly disclosed.
``(ii) Permissible disclosure to national
security agencies of the federal government.--
The list required by paragraph (1)(A), and any
portion thereof, may be disclosed by the
Secretary only--
``(I) within the Department of
Health and Human Services, and pursuant
to reporting under subsection (f); and
``(II) for purposes of evaluating
supply chain vulnerabilities and other
national security issues, with national
security agencies of the Federal
Government.
``(B) List of top 3 countries.--The Secretary shall
publicly disclose the list required by paragraph
(1)(B), but may not include in any such disclosure--
``(i) information about an identifiable
drug or active pharmaceutical ingredient; or
``(ii) proprietary information regarding a
drug or active pharmaceutical ingredient,
including 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.
``(c) Timelines.--
``(1) Initial list.--The Secretary shall compile the
initial lists of drugs under subsections (a) and (b) not later
than 180 days after the date of enactment of the Protecting Our
Essential Medicines Act.
``(2) Updates.--The Secretary shall update the lists of
drugs under subsections (a) and (b), as the Secretary
determines necessary and appropriate, and not less frequently
than every 2 years.
``(d) Cybersecurity Measures.-- Prior to sharing of any lists
required by subsection (a) or (b), within the Department of Health and
Human Services or to national security agencies, the Secretary shall
ensure that robust cybersecurity measures are in place to prevent
inappropriate access to, or unauthorized disclosure of, the list or any
information related to the list.
``(e) Interagency Task Force.--
``(1) Establishment.--Not later than 30 days after the date
of enactment of the Protecting Our Essential Medicines Act, the
Secretary shall establish an interagency task force for
purposes of identifying drugs to include in the list of
critical drugs, as described in subsection (a)(1)(C) and
consulting with the Secretary with respect to compiling,
maintaining, and updating the list under subsection (b). The
task force shall be comprised of representatives of the Federal
Government as the Secretary, in consultation with the
Commissioner of Food and Drugs, the Director of the Centers for
Disease Control and Prevention, the Secretary of Defense, the
Assistant Secretary for Preparedness and Response, the
Secretary of Homeland Security, the Commissioner of U.S.
Customs and Border Protection, and the Director of National
Intelligence, determines appropriate.
``(2) Procedures.--Not later than 60 days after the date of
enactment of the Protecting Our Essential Medicines Act, the
task force established under paragraph (1) shall submit a
report on the procedures such task force will follow in making
determinations with respect to drugs as described in clauses
(i) and (ii) of subsection (a)(1)(C) to--
``(A) the Committee on Health, Education, Labor,
and Pensions, the Committee on Finance, and the
Committee on Armed Services of the Senate; and
``(B) the Committee on Energy and Commerce, the
Committee on Ways and Means, and the Committee on Armed
Services of the House of Representatives.
``(f) Reporting.--Upon compiling the initial list of drugs as
required under subsections (a) and (b), and upon making each update to
such lists as described in subsection (c)(2), the Secretary shall
submit the list of drugs to--
``(1) the Secretary of Defense;
``(2) the Attorney General; and
``(3) the Director of National Intelligence.''.
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