118th Congress · HOUSE BILLBILL

H.R. 3793Ensuring Access to Lifesaving Drugs Act of 2023

To amend the Federal Food, Drug, and Cosmetic Act to require manufacturers of life-saving drugs to submit data and information to assess the stability of the drugs and determine their longest supported expiration date, and for other purposes.

Health
Introduced Jun 5, 2023
Last action Jun 9, 2023
Pipeline · Bill → Law
Step 1
Introduced
Jun 5, 2023
Step 2
Referred
Jun 9, 2023
E&C
Step 3
Committee
Step 4
House floor
Step 5
Senate
Step 6
Resolve Changes
Step 7
Signed
SummaryCRS 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 no...

Provisions · 2 sectionsIntroduced in House
Timeline · 3 actions
Jun 9, 2023
Referred to the Subcommittee on Health.
Jun 5, 2023
Introduced in House
Jun 5, 2023
Referred to the House Committee on Energy and Commerce.