[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4327 Introduced in Senate (IS)]
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119th CONGRESS
2d Session
S. 4327
To require regulatory review of pharmaceutical products from Chinese
entities, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 16 (legislative day, April 14), 2026
Mr. Cotton introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To require regulatory review of pharmaceutical products from Chinese
entities, 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 ``Securing America's Drug Supply from
Communist China Act''.
SEC. 2. REGULATORY REVIEW OF PHARMACEUTICAL PRODUCTS FROM CHINESE
ENTITIES.
(a) Definitions.--In this section:
(1) Chinese entity.--The term ``Chinese entity'' means an
entity organized under the laws of the People's Republic of
China or otherwise subject to the jurisdiction of the
Government of the People's Republic of China.
(2) Drug application.--The term ``drug application'' means
an application submitted under subsection (b) or (j) of section
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)
or subsection (a) or (k) of section 351 of the Public Health
Service Act (42 U.S.C. 262).
(3) PRC-, ccp-, or pla-affiliated entity.--
(A) In general.--The term ``PRC-, CCP-, or PLA-
affiliated entity'' means any entity that receives
support directly or indirectly from the Government of
the People's Republic of China, the Chinese Communist
Party, or the People's Liberation Army, including--
(i) an entity owned or controlled by the
Government of the People's Republic of China or
an entity owned or controlled by such an
entity; and
(ii) an entity that has on its board of
directors one or more individuals described in
subparagraph (B) who collectively hold an
ownership interest in the entity.
(B) Individuals described.--An individual described
in this subparagraph is--
(i) an official of the Government of the
People's Republic of China, the Chinese
Communist Party, or the People's Liberation
Army; or
(ii) an executive officer of an entity
owned or controlled by the Government of the
People's Republic of China, including the
president or vice president of, or any other
executive officer who performs a policy-making
function for, the entity.
(4) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services, acting through the Commissioner
of Food and Drugs.
(b) Review of Certain New Drug Applications Submitted on or After
Enactment.--
(1) In general.--The Secretary, in coordination with the
Office of National Security of the Department of Health and
Human Services, shall review each drug application submitted on
or after the date of enactment of this Act by a sponsor that is
a Chinese entity, or an entity licensing a product owned by a
Chinese entity, to determine whether such sponsor is a PRC-,
CCP-, or PLA-affiliated entity. In carrying out this paragraph,
the Secretary may review any Drug Master File referenced by
such an application.
(2) Denied approval of certain applications.--The Secretary
shall not approve any drug application submitted on or after
the date of enactment of this Act if the Secretary has
determined under paragraph (1) that the sponsor of such
application is a PRC-, CCP-, or PLA-affiliated entity.
(c) Review of Certain New Drug Applications Submitted Prior to
Enactment.--
(1) In general.--The Secretary, in coordination with the
Office of National Security of the Department of Health and
Human Services, shall review each drug application submitted
during the period described in paragraph (2) to determine
whether the sponsor of the application and, if applicable, the
holder of the approved application, is a PRC-, CCP-, or PLA-
affiliated entity. In carrying out this paragraph, the
Secretary may review any Drug Master File referenced by such an
application.
(2) Period described.--The period described in this
paragraph is the period beginning on January 1, 2016, and
ending on the day before the date of enactment of this Act.
(d) Refusal of Certain Drugs Offered for Import.--
(1) In general.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended by adding at the end
the following;
``(v) Import of Drugs Sponsored by PRC-, CCP-, and PLA-Affiliated
Entities.--
``(1) In general.--The Secretary shall furnish to the
Commissioner of U.S. Customs and Border Protection a list of
drugs for which the sponsor or holder of an approved
application is determined under section 2(c) of the Securing
America's Drug Supply from Communist China Act to be a PRC-,
CCP-, or PLA-affiliated entity.
``(2) Refusal.--If it appears that a drug imported or
offered for import into the United States is a drug for which
the sponsor or holder of an approved application is determined
under section 2(c) of the Securing America's Drug Supply from
Communist China Act to be a PRC-, CCP-, or PLA-affiliated
entity, then such drug shall be refused, except as provided in
paragraphs (3) and (4), and the Commissioner of U.S. Customs
and Border Protection shall destroy, without the opportunity
for export, such drug.
``(3) Compliance.--
``(A) In general.--The Secretary shall establish a
process under which the sponsor of a drug described in
paragraph (2) or the holder of an approved application
for such a drug, as applicable, may--
``(i) demonstrate to the Secretary that it
is no longer a PRC-, CCP-, or PLA-affiliated
entity; or
``(ii) within 180 days, sell the approved
application for such drug to an entity that is
not a PRC-, CCP-, or PLA-affiliated entity.
``(B) Requirement.--The process established under
subparagraph (A) shall include the opportunity to
appear before the Secretary and introduce testimony.
``(C) Notification.--If the Secretary is satisfied
with the action taken under clause (i) or (ii) of
subparagraph (A), the Secretary shall notify the
Commissioner of U.S. Customs and Border Protection.
``(4) Waiver.--The Commissioner of U.S. Customs and Border
Protection may waive the requirements of paragraph (2) and
authorize the import of a drug described in such paragraph if
the Secretary has determined that the refusal of the import
would create or exacerbate a drug shortage in the United
States.
``(5) Definition of prc-, ccp-, or pla-affiliated entity.--
In this subsection, the term `PRC-, CCP-, or PLA-affiliated
entity' has the meaning given such term in section 2(a) of the
Securing America's Drug Supply from Communist China Act.''.
(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section and the amendments made by this
section $5,000,000, to remain available until expended.
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