HR 843 · Prompt Approval of Safe Generic Drugs Act
Referred to the House Committee on Energy and Commerce.
- Introduced
- Jan 31, 2025
- Latest action
- Jan 31, 2025
- Sponsor
- Rep. Nanette Diaz Barragán [D-CA-44]
- Policy area
- Health
- Cosponsors
- 0
Summary
Prompt Approval of Safe Generic Drugs Act This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a generic drug despite the omission of certain safety information from the generic drug's labeling. Specifically, the FDA may not deem an abbreviated application for approval of a generic drug ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's patent or exclusivity protections. Similarly, a drug that is approved under this bill may not be considered mislabeled for lacking such safety information. Generally, an abbreviated application, for the purposes of this bill, is one that (1) uses required information from studies not conducted by the applicant; or (2) seeks approval of a drug that is, for drug approval purposes, a duplicate of an already-approved drug (i.e., a generic drug). Currently, the labeling for such a generic drug must generally be identical to that of the already-approved drug. This bill provides an exception to that requirement under the specified circumstances. For any drug approved under this bill, the FDA must require the drug's labeling to include any safety information that is necessary to assure safe use.
Recent actions
- Jan 31, 2025 Referred to the House Committee on Energy and Commerce.
- Jan 31, 2025 Introduced in House
- Jan 31, 2025 Introduced in House
Votes
No recorded votes are available for this bill.