H.R. 2831 · 117th Congress
Prompt Approval of Safe Generic Drugs Act
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
BarragánSponsorNo cosponsors.
This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a drug even if the drug's labeling lacks certain safety information.
What it does: CRS summary · Introduced in House · Apr 26, 2021
Prompt Approval of Safe Generic Drugs Act
This bill authorizes the Food and Drug Administration (FDA) to approve certain applications to market a drug even if the drug's labeling lacks certain safety information.
Specifically, an abbreviated application for approval of a generic drug shall not be ineligible for approval solely because the drug's labeling omits safety information that is protected under another drug's exclusivity protections. Similarly, a drug that is approved under this bill shall 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.
For any drug approved under this bill, the FDA shall 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 (Apr 27, 2021): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Apr 26, 2021
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.