Protecting Americans from Unsafe Drugs Act of 2026
Sponsored By: Representative Dexter
Introduced
Summary
Expands federal recall authority from controlled substances to all drugs. It would also name the Director of the Center for Biologics Evaluation and Research in recall authority and apply recall orders to drug imports and exports.
Show full summary
- Patients and families would get broader protection because recalls could target any unsafe drug, not only controlled substances.
- Drug makers and companies that import or export medicines would face wider recall coverage affecting domestic and cross-border shipments.
- Regulators would explicitly include the Director of the Center for Biologics Evaluation and Research or senior officials in issuing or overseeing recall orders.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
More FDA recall power for drugs
If enacted, this bill would let the FDA use its recall and import/export order powers for all drugs, not just controlled substances. It would change statute language to replace "controlled substance" with "drug" in the key recall rules and in import/export enforcement. It would also let the Director of the Center for Biologics Evaluation and Research (or a senior official) join FDA leadership in issuing or amending recall orders and would clarify which orders may be amended. This would extend recall reach to more manufacturers, distributors, pharmacies, importers, exporters, and consumers, and could raise compliance costs for regulated drug makers and sellers.
Sponsors & CoSponsors
Sponsor
Dexter
OR • D
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
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