WeVote
Log In

Bill

Bill

S 4327

Securing America’s Drug Supply from Communist China Act

119th Congress Introduced by Tom Cotton

The bill blocks FDA approval and imports of drugs linked to PRC/CCP/PLA-affiliated entities and allows divestment or reorganization to avoid denial.

Introduced in Senate
0
WeVote Research Nonpartisan
Bill Summary · S 4327

Summary of S. 4327 (119th Congress) — Securing America’s Drug Supply from Communist China Act

Purpose
- The bill aims to tighten regulatory scrutiny and potential limitations on pharmaceutical products associated with entities affiliated with the PRC, CCP, or PLA. It seeks to prevent drug applications tied to such entities from receiving FDA approval and to empower U.S. authorities to block or remove imports linked to these entities, with a focus on safeguarding the U.S. drug supply.

Key Definitions
- Chinese Entity: An entity organized under PRC law or subject to its jurisdiction.
- Drug Application: An application under FD&C Act §505 (drug applications) or the Public Health Service Act §351.
- PRC-, CCP-, or PLA-Affiliated Entity: Any entity receiving support from the PRC government, the Chinese Communist Party, or the PLA, including:
- Entities owned/controlled by these bodies.
- Entities with on their boards individuals who meet certain described roles (e.g., officials or executive officers performing policy-making functions).
- Secretary: The Secretary of Health and Human Services, acting through the FDA Commissioner.
- Coordination: With the HHS Office of National Security.

Main Provisions

1) Regulatory Review of New Drug Applications from Chinese Entities (Section 2)
- For drug applications submitted on or after enactment, the Secretary must review whether the sponsor is a PRC-, CCP-, or PLA-affiliated entity (including reviewing referenced Drug Master Files).
- If determined affiliated, the Secretary must not approve the drug application.

2) Review of Applications Submitted Before Enactment (Section 2)
- For drug applications submitted between January 1, 2016, and the enactment date, the Secretary must determine if the sponsor or holder is PRC-, CCP-, or PLA-affiliated, potentially revisiting prior approvals.

3) Import Refusal for Drugs Linked to Affiliated Entities (Section 2(d))
- Adds a new provision to FD&C Act §801:
- The Secretary must provide the list of drugs whose sponsor/holder is PRC-, CCP-, or PLA-affiliated to CBP.
- CBP must refuse import and destroy such drugs, with certain exceptions.
- Provides a process for sponsors to demonstrate cessation of affiliation or to sell the approved application to a non-affiliated entity within 180 days; includes a hearing process.
- CBP may waive the import denial if refusal would create or worsen a U.S. drug shortage.
- Defines PRC-, CCP-, or PLA-affiliated entity consistently with Section 2(a).

4) Appropriations (Section 5)
- Authorizes $5,000,000, to remain available until expended, to carry out Section 2 and related amendments.

Impacts and Stakeholders

  • Affected Parties:
    • Drug sponsors and applicants with ties to Chinese entities or those licensing products owned by Chinese entities.
    • FDA/Secretary of Health and Human Services (coordination with the Office of National Security).
    • U.S. Customs and Border Protection (import refusals and enforcement).
  • Regulators’ Actions:
    • Heightened due diligence on Chinese-affiliated sponsors; potential denial of approvals for affected drug applications.
    • Mechanisms to block or destroy imported drugs tied to affiliated entities unless exceptions apply.
    • A pathway for sponsors to divest or reorganize to maintain import viability, subject to compliance and hearings.
  • Timing/Process:
    • Immediate review for post-enactment applications.
    • Retrospective review for applications from 2016 up to enactment.
    • A separate 180-day window for sponsors to remedy affiliation (sale or reorganization) upon notification.

Overall Effect
- The bill seeks to substantially increase scrutiny and potential denial of drug approvals and imports associated with PRC-, CCP-, or PLA-affiliated entities, reinforcing a policy aim of securing the U.S. drug supply from certain Chinese connections. It also creates enforcement mechanisms via CBP and sets a finite funding level for implementation.

Compiled from official sources — confirm details with the bill’s official record.

Sign in to ask a question.