PRIA Logo™
119-hr-7980119th CongressWALLET

Protecting Americans from Unsafe Drugs Act of 2026

Sponsored By: Representative Dexter, Maxine [D-OR-3]

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.

Personalized for You

How does this bill affect your finances?

Personalize government policy and PRIA will tell you what this bill means for your household, plus every other piece of legislation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.

Free to download

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, Maxine [D-OR-3]

OR • D

Cosponsors

There are no cosponsors for this bill.

Roll Call Votes

No roll call votes available for this bill.

View on Congress.gov
Back to Legislation