The "Protecting Americans from Unsafe Drugs Act of 2026" significantly expands the Food and Drug Administration's (FDA) authority regarding drug recalls and distribution. Currently, the FDA's power to issue mandatory orders to cease distribution and recall is primarily limited to controlled substances. This bill amends the Federal Food, Drug, and Cosmetic Act to extend these critical powers to all drugs , ensuring a broader scope of regulatory oversight. Specifically, it modifies Section 569D of the FD&C Act by replacing references to "controlled substance" with "drug" and clarifies the officials authorized to issue such orders, including the Director of the Center for Biologics Evaluation and Research. Furthermore, the bill updates Section 801(a) of the Act to ensure that imported and exported drugs are also subject to these expanded recall and cease distribution orders. These changes aim to enhance public safety by providing the FDA with more comprehensive tools to remove potentially unsafe drugs from the market.
Protecting Americans from Unsafe Drugs Act of 2023
Introduced in House
Referred to the House Committee on Energy and Commerce.
Health
Protecting Americans from Unsafe Drugs Act of 2026
USA119th CongressHR-7980| House
| Updated: 3/18/2026
The "Protecting Americans from Unsafe Drugs Act of 2026" significantly expands the Food and Drug Administration's (FDA) authority regarding drug recalls and distribution. Currently, the FDA's power to issue mandatory orders to cease distribution and recall is primarily limited to controlled substances. This bill amends the Federal Food, Drug, and Cosmetic Act to extend these critical powers to all drugs , ensuring a broader scope of regulatory oversight. Specifically, it modifies Section 569D of the FD&C Act by replacing references to "controlled substance" with "drug" and clarifies the officials authorized to issue such orders, including the Director of the Center for Biologics Evaluation and Research. Furthermore, the bill updates Section 801(a) of the Act to ensure that imported and exported drugs are also subject to these expanded recall and cease distribution orders. These changes aim to enhance public safety by providing the FDA with more comprehensive tools to remove potentially unsafe drugs from the market.