S. 4327

[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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