Securing America’s Drug Supply from Communist China Act
- Sponsor
- Sen. Cotton, Tom [R-AR]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Apr 16, 2026
Bottom line
This bill aims to restrict the approval and import of pharmaceutical products from Chinese government-affiliated entities into the United States to enhance drug supply chain security.
What it actually does
This bill mandates the Secretary of Health and Human Services, through the FDA, to review drug applications from Chinese entities to determine if they are affiliated with the Government of the People's Republic of China, the Chinese Communist Party, or the People's Liberation Army. It prohibits approval of new applications from such affiliated entities and requires the refusal and destruction of imported drugs from previously approved applications if the sponsor or holder is deemed affiliated, with limited exceptions for compliance or drug shortages.
Proponents argue
Proponents argue that this bill is crucial for national security, reducing reliance on potentially hostile foreign adversaries for essential medicines, and safeguarding the integrity and safety of the U.S. drug supply chain from entities that may pose risks due to their ties to the Chinese government, military, or Communist Party.
Opponents contend
Opponents might contend that such broad restrictions could disrupt the existing drug supply, potentially leading to shortages of critical medications, increasing costs for consumers, and hindering access to affordable drugs, especially if alternative suppliers are not readily available or cannot scale production quickly enough.
The bill is relatively short and clearly structured, making it accessible for a quick read to understand its core provisions.
Section 2(a)
Definitions of Chinese Entity and PRC-, CCP-, or PLA-Affiliated Entity
This section defines 'Chinese entity' as any entity organized under or subject to the laws of the People's Republic of China. Crucially, it defines 'PRC-, CCP-, or PLA-affiliated entity' as any entity receiving direct or indirect support from the Chinese government, Communist Party, or People's Liberation Army, including those owned or controlled by them, or those with officials/executives of such entities on their board holding an ownership interest.
Supporters argue
Supporters argue that these definitions are essential to precisely target entities that pose national security risks, ensuring that the scope of the bill effectively covers various forms of Chinese state influence without being overly broad or easily circumvented.
Critics contend
Critics might argue that the definitions, particularly for 'PRC-, CCP-, or PLA-affiliated entity,' are overly broad and could inadvertently capture legitimate private businesses with minimal or indirect ties, leading to unintended disruptions or unfair targeting.
Tradeoffs
Balances the need for comprehensive security against the risk of overreach and potential economic disruption.
Section 2(b)
Review and Denial of New Drug Applications from Affiliated Chinese Entities
The Secretary of HHS, through the FDA and in coordination with the Office of National Security, must review all new drug applications submitted by Chinese entities after the bill's enactment. If the sponsor is determined to be a PRC-, CCP-, or PLA-affiliated entity, the application shall not be approved. This includes reviewing Drug Master Files.
Section 2(c)
Retrospective Review of Drug Applications Approved Since 2016
The Secretary, coordinating with the Office of National Security, must review all drug applications submitted between January 1, 2016, and the day before the bill's enactment. The purpose is to determine if the sponsor or approved application holder is a PRC-, CCP-, or PLA-affiliated entity, including reviewing referenced Drug Master Files.
Section 2(d) amending 21 U.S.C. 381
Refusal and Destruction of Imported Drugs from Affiliated Chinese Entities
This section amends the Federal Food, Drug, and Cosmetic Act to require the Secretary to provide U.S. Customs and Border Protection (CBP) with a list of drugs whose sponsors/holders are identified as PRC-, CCP-, or PLA-affiliated entities under the retrospective review. These drugs shall be refused import and destroyed without opportunity for export, with exceptions for compliance or to prevent drug shortages.
Section 2(d)(3) and (4)
Pathways for Compliance and Drug Shortage Waivers
This provision establishes a process for an identified entity to demonstrate it is no longer affiliated or to sell its approved application to a non-affiliated entity within 180 days. It also allows the Commissioner of U.S. Customs and Border Protection to waive import refusal if the Secretary determines it would create or exacerbate a drug shortage in the United States.
Section 2(e)
Funding for Implementation
This section authorizes an appropriation of $5,000,000 to remain available until expended, to carry out the provisions of this section and the amendments made by it.
The Secretary 'may review any Drug Master File referenced by such an application' when determining if a sponsor is an affiliated entity.
Section 2(b)(1) and 2(c)(1)
Why it matters:Standard legislative practice to include operational details within the scope of authority.
Case for: Supporters would argue that reviewing DMFs is critical to a comprehensive assessment, as the actual manufacturing source and its affiliations are often detailed there, preventing circumvention of the bill's intent.
Case against: Critics might argue that this adds significant complexity and potential delays to the review process, as DMFs are proprietary and often involve multiple layers of suppliers, making affiliation tracing difficult.
Estimated impact: Potentially broad impact on the supply chain for generic drugs, as many active pharmaceutical ingredients (APIs) and finished drug products rely on DMFs from Chinese manufacturers.