Securing America’s Drug Supply from Communist China Act
Sponsored By: Senator Cotton, Tom [R-AR]
Introduced
Summary
Block FDA approval and CBP import of drugs tied to Chinese government‑affiliated entities. The bill creates a federal system to identify sponsors linked to the People's Republic of China (PRC), the Chinese Communist Party (CCP), or the People's Liberation Army (PLA) and to deny approvals or imports when affiliation is found.
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- Patients and health providers could see specific drugs blocked from U.S. approval or import if their sponsor is found affiliated, though a waiver is allowed when refusing import would worsen a drug shortage.
- U.S. and foreign drug sponsors face stricter review. New drug applications submitted after enactment can be denied for affiliation. NDAs filed from January 1, 2016 through the retroactive review period are also subject to review. Sponsors may avoid import bans by proving loss of affiliation or by selling an approved application to a non‑affiliated buyer within 180 days.
- Importers and Customs and Border Protection will get an HHS list of affected drugs and must refuse and may destroy shipments unless remediation steps succeed.
- The Secretary of Health and Human Services, through the FDA Commissioner, must implement reviews, coordinate with national security offices, and may review referenced Drug Master Files.
*Authorizes $5.0 million in appropriations to implement these measures, increasing federal spending by that amount.*
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Bill Overview
Analyzed Economic Effects
4 provisions identified: 1 benefits, 0 costs, 3 mixed.
Process to fix affiliation and $5M funding
If enacted, the Secretary would set up a formal process for a sponsor or holder found to be affiliated to either show it is no longer affiliated or to sell the approved application within 180 days to a non-affiliated buyer. The process must let the sponsor appear and give testimony. If the Secretary is satisfied, she would notify CBP. The bill also authorizes $5,000,000 to carry out these rules, and the money would remain available until spent.
Customs block and waiver for China-linked drug imports
If enacted, the Secretary would give U.S. Customs and Border Protection a list of drugs whose sponsor or approved-app holder is determined to be affiliated with China. If an imported drug appears on that list, CBP would refuse the drug and the Commissioner would destroy the shipment, unless the sponsor completes the bill’s remediation process or CBP grants a waiver. The CBP Commissioner may allow importation if the Secretary determines that refusal would create or worsen a U.S. drug shortage.
HHS review and ban on China-affiliated drug approvals
If enacted, HHS (through FDA and in coordination with the Office of National Security) would review certain drug applications to see if the sponsor or approved-app holder is tied to China. Reviews would cover applications filed from January 1, 2016 through the day before enactment, and applications filed on or after enactment when the sponsor is a Chinese entity or licenses a product from one. The Secretary could review any referenced Drug Master File. If the Secretary finds the sponsor is PRC-, CCP-, or PLA-affiliated, the Secretary would be barred from approving an NDA filed on or after enactment.
New rules for identifying China-linked drug companies
If enacted, the bill would create new legal definitions to identify companies tied to the People’s Republic of China, the Chinese Communist Party, or the People’s Liberation Army. The rules would count entities organized under Chinese law, entities getting direct or indirect PRC/CCP/PLA support, and firms whose boards include certain Chinese officials or executives. "Drug application" and the role of the Secretary of Health and Human Services (acting through FDA) would be defined so these terms apply right when the bill is enacted.
Sponsors & CoSponsors
Sponsor
Cotton, Tom [R-AR]
AR • R
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov