Securing America’s Drug Supply from Communist China Act
- Bill Number
- S. 4327
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-04-16: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Last Updated
- 2026-05-12T14:00:39Z
AI-Generated Summary
Purpose
This bill aims to protect the U.S. drug supply by requiring the Food and Drug Administration (FDA) to review and potentially block pharmaceuticals linked to Chinese entities affiliated with the People's Republic of China (PRC), Chinese Communist Party (CCP), or People's Liberation Army (PLA). It seeks to prevent approvals and imports of such drugs to address national security concerns.
Key Provisions
- Definitions:
- Chinese entity: A company organized under PRC laws or subject to PRC government control.
- PRC-, CCP-, or PLA-affiliated entity: Broadly includes entities receiving support from, owned/controlled by, or having board members/executives tied to the PRC government, CCP, or PLA.
- Drug application: Applications for FDA approval of new drugs or biologics (living medicines like vaccines).
- Review of New Applications (Post-Enactment): FDA must check applications from Chinese entities (or those licensing Chinese-owned products) submitted after the bill's enactment. Approval is denied if the sponsor is affiliated; FDA can also review referenced Drug Master Files (technical dossiers on drug components).
- Review of Past Applications (2016 to Enactment): FDA reviews applications from that period to identify affiliated sponsors or holders.
- Import Restrictions: Amends the Federal Food, Drug, and Cosmetic Act to:
- Provide U.S. Customs and Border Protection (CBP) a list of affected drugs.
- Require refusal and destruction of imports (no export option) unless:
- Sponsor/holder proves it is no longer affiliated or sells the application to a non-affiliated entity within 180 days (with hearing opportunity).
- CBP waives for drug shortages.
- Funding: Authorizes $5 million for implementation.
Significant Changes to Existing Law
- Adds a new subsection (v) to Section 801 of the Federal Food, Drug, and Cosmetic Act, mandating automatic refusal and destruction of specified drug imports, with limited exceptions—previously, imports were refused only for safety/adulteration issues, without this targeted national security review.
Potential Impacts
- Government Agencies: Increases workload for FDA (with HHS Office of National Security), CBP; requires new processes for reviews, lists, hearings, and waivers.
- Citizens: Could reduce access to certain drugs, risking shortages (mitigated by waivers), but aims to enhance supply chain security.
- International Relations: May strain U.S.-China trade/pharma ties by targeting Chinese-linked products, potentially prompting retaliation.
Main Stakeholders Affected
- Pharmaceutical Companies: Especially Chinese entities or those with PRC/CCP/PLA ties—face application denials, import blocks, divestiture pressure.
- U.S. Government Agencies: FDA, HHS, CBP (implementation/enforcement roles).
- Importers and Supply Chain: U.S. firms relying on affected drugs.
- Patients and Healthcare Providers: Potential disruptions to drug availability.
Notable Legal, Constitutional, or Political Implications
- Legal: Introduces due process via hearings for compliance challenges; relies on FDA's existing authority but expands it to national security grounds.
- Constitutional: Could face challenges on equal protection or commerce clause if seen as discriminatory, though national security justifications may prevail.
- Political: Reflects heightened U.S. concerns over foreign influence in critical sectors like pharmaceuticals; no explicit expiration or sunset clause.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Recent Actions
- 2026-04-16: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2026-04-16: Introduced in Senate
Bill Versions
- Securing America’s Drug Supply from Communist China Act — issued 2026-04-16 — PDF (7 pages)