S 4327 — Securing America’s Drug Supply from Communist China Act

Summary

This bill requires the FDA to review pharmaceutical drug applications from Chinese entities and entities affiliated with the Chinese government, Communist Party, or People's Liberation Army to determine their affiliation status. The FDA may not approve new drug applications from entities determined to be PRC-, CCP-, or PLA-affiliated. The bill also requires the FDA to review previously submitted applications from January 2016 to the date of enactment and prohibits imports of drugs from affiliated entities, with U.S. Customs destroying such drugs upon import. Drug sponsors have 180 days to demonstrate they are no longer affiliated or to sell their approved application to a non-affiliated entity. The bill allows an exception if import refusal would create or exacerbate drug shortages in the United States.

AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.

Sponsor (1)

Sen. Cotton, Tom [R-AR] (R-AR)

Money behind the sponsor

Top reported contributors to Tom Cotton’s campaign committee (2024 cycle) — who funds the bill’s sponsor, not a claim about this bill. Data from FEC.

NULL $80,461
APOLLO MANAGEMENT $25,600
APOLLO GLOBAL MANAGEMENT $19,800
BRODIE GENERATIONAL CAPITAL PARTNERS $13,200
APOLLO $11,600

Organizations whose employees gave the most — itemized individual contributions grouped by the donor’s reported employer (FEC Schedule A). Full finance for Tom Cotton → · Outside spending →

Actions (2)

Apr 16, 2026 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. · senate
Apr 16, 2026 Introduced in Senate

Similar bills (6)

Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.

Full text

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. <all>

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