PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the Subcommittee on Health.
Congressional Research Service
Version 00 · 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.
People & committees
Rep. Slotkin, Elissa [D-MI-7] · D–MI
Legislative record
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Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: May 27, 2025. Consult Congress.gov for the current record.
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