Protecting Americans from Unsafe Drugs Act of 2026

Bill Number

H.R. 7980

Origin Chamber

House

Congress

119th Congress, Session 2

Policy Area

Health

Status

Introduced

Latest Action

2026-03-18: Referred to the House Committee on Energy and Commerce.

Last Updated

2026-04-06T13:23:55Z

AI-Generated Summary

Purpose This legislation amends the Federal Food, Drug, and Cosmetic Act to broaden the Food and Drug Administration's (FDA) authority to order the recall of unsafe products. It extends existing recall powers, previously limited to controlled substances, to apply to all drugs.

Key Provisions

• Renames and updates Section 569D to cover "drugs" instead of only "controlled substances," allowing the FDA to issue orders to cease distribution and require recalls for any drug.
• Permits the Director of the Center for Drug Evaluation and Research or the Director of the Center for Biologics Evaluation and Research (or senior officials) to issue or amend such orders.
• Updates import and export rules in Section 801(a) to reference orders for any drug subject to a recall, not just controlled substances.

Significant Changes to Existing Law The bill removes the restriction that limited recall authority to controlled substances, expanding it to all drugs. It also clarifies the FDA officials authorized to handle recall orders and aligns import/export enforcement with the broader scope.

Potential Impacts

• Government agencies: Strengthens FDA enforcement tools for drug safety across all products.
• Citizens: May improve protection against unsafe drugs by enabling faster recalls.
• International relations: Could affect imports and exports of drugs by applying recall orders to foreign shipments.

Main Stakeholders Affected

• FDA and its centers responsible for drug evaluation.
• Drug manufacturers, distributors, and importers/exporters.
• Patients and consumers who use prescription or over-the-counter drugs.

Notable Legal, Constitutional, or Political Implications The changes expand administrative authority within existing FDA frameworks without altering core constitutional powers. No major new legal conflicts are introduced in the text, though broader recall powers could lead to increased regulatory oversight of the pharmaceutical industry.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Dexter, Maxine [D-OR-3]

Recent Actions

• 2026-03-18: Referred to the House Committee on Energy and Commerce.
• 2026-03-18: Introduced in House
• 2026-03-18: Introduced in House

Bill Versions

• Protecting Americans from Unsafe Drugs Act of 2026 — issued 2026-03-18 — PDF (3 pages)