118th Congress Health
H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023
Introduced
- Introduced (completed)
- Passed House (not reached)
- Passed Senate (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
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 Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- Scott Peters D-CA
- John Sarbanes D-MD
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Other bills by Elissa Slotkin
History
- Introduced in the House by Elissa Slotkin.
Show the full action history (3 actions)
- Referred to the Subcommittee on Health.
- Introduced in House
- Referred to the House Committee on Energy and Commerce.