Ensuring Access to Lifesaving Drugs Act of 2023

Summary

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.   

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Timeline

1. 5 June 2023

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 5 June 2023

   Introduced

   Introduced in House

   Source: IntroReferral

3. 5 June 2023

   Introduced

   Introduced in House

   Source: IntroReferral

4. 9 June 2023

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 5 June 2023 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 5 June 2023

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 5 June 2023

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 5 June 2023

  Open at official source

Sponsors

• Sen. Slotkin, Elissa [D-MI] · D · Sponsor
• Scott Peters · D · Cosponsor
• John Sarbanes · D · Cosponsor
• · hsif00 · Standing

Related records

• related to ← Protecting PAHPA Act of 2023