H.R. 3793 · 118th Congress
Ensuring Access to Lifesaving Drugs Act of 2023
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Never voted on. It didn't reach a floor vote before the 118th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
SlotkinSponsor2 cosponsors · 2 D
0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill allows the Food and Drug Administration (FDA) to obtain additional information from manufacturers of life-saving drugs in order to assess and potentially modify the drug's expiration date.
What it does: CRS summary · Introduced in House · Jun 5, 2023
Ensuring Access to Lifesaving Drugs Act of 2023
This bill allows the Food and Drug Administration (FDA) to obtain additional information from manufacturers of life-saving drugs in order to assess and potentially modify the drug's expiration date. (The bill defines life-saving drug as a medical countermeasure or a drug that is in short supply and that is life-supporting, life-sustaining, or intended to be used to prevent or treat a debilitating disease or condition in humans or animals.)
Specifically, the FDA may order a manufacturer of a life-saving drug to submit data and other information from any stage of the drug's development in order to assess the drug's stability and the longest supported expiration date. If such information is not readily available, the FDA may order the manufacturer to conduct additional studies. The FDA may require changes to the drug's label accordingly. Manufacturers that fail to comply are subject to civil penalties.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Ensuring Access to Lifesaving Drugs Act of 2023
Latest action (Jun 9, 2023): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Jun 5, 2023
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.