Sponsor
Thomas Bryant Cotton
Senator · R-AR
Senator · R-AR
The bill strengthens supply-chain security and transparency by restricting drugs tied to certain foreign affiliations, but risks drug shortages, higher prices, compliance burdens, and due-process/privacy concerns for affected companies and patients.
Patients with chronic conditions and hospitals/health systems would have reduced exposure to drugs whose sponsors are affiliated with the PRC/CCP/PLA, addressing potential national-security supply-chain risks.
Hospitals and health systems would gain greater supply-chain transparency because FDA must review past and new applications and share a list of affected drugs with CBP, helping procurement and risk management.
Drug sponsors and patients could preserve access because the bill creates a regulatory pathway to resolve affiliation concerns (demonstrate disaffiliation or sell within 180 days) rather than imposing immediate permanent bans.
Patients (including those with chronic conditions), Medicaid beneficiaries, and hospitals could face drug shortages or reduced access if FDA blocks approvals or CBP detains/destroys imports tied to affiliated sponsors.
Patients and taxpayers could face higher drug prices if supply is disrupted and fewer manufacturers are eligible to supply approved products.
Drug sponsors, importers, and hospitals will incur compliance, legal, and transactional costs (for example, arranging sales within 180 days or litigating affiliation determinations).
Based on analysis of 2 sections of legislative text.
FDA must identify drug sponsors affiliated with PRC/CCP/PLA, block approvals for covered new applications, and require Customs to refuse/destroy imports of listed drugs with limited exceptions.
Official title: Require regulatory review of pharmaceutical products from Chinese entities, and for other purposes.
Introduced April 16, 2026 by Thomas Bryant Cotton · Last progress April 16, 2026
Blocks FDA approval and U.S. importation of drugs when the drug application sponsor is found to be affiliated with the People’s Republic of China (PRC), the Chinese Communist Party (CCP), or the People’s Liberation Army (PLA). It directs HHS/FDA to review past and new drug applications to identify such affiliations, requires FDA to provide Customs a list of affected drugs, authorizes Customs to refuse and destroy imports on that list (with limited exceptions for shortage relief and a short appeal/sale window), and provides $5 million in funding to carry out the law.