H.R. 843 · 119th Congress
Prompt Approval of Safe Generic Drugs Act
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BarragánSponsorNo cosponsors.
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.
What it does: CRS summary · Introduced in House · Jan 31, 2025
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Prompt Approval of Safe Generic Drugs Act
Latest action (Jan 31, 2025): Referred to the House Committee on Energy and Commerce.
Policy area: Health · Origin: House · Introduced: Jan 31, 2025
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.