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Ensuring Access to Lifesaving Drugs Act of 2023

USA118th CongressHR-3793| House 
| Updated: 6/9/2023
Elissa Slotkin

Elissa Slotkin

Democratic Representative

Michigan

Cosponsors (2)
Scott H. Peters (Democratic)John P. Sarbanes (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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
Jun 5, 2023
Introduced in House
Jun 5, 2023
Referred to the House Committee on Energy and Commerce.
Jun 9, 2023
Referred to the Subcommittee on Health.
  • June 5, 2023
    Introduced in House


  • June 5, 2023
    Referred to the House Committee on Energy and Commerce.


  • June 9, 2023
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 118-4697: Protecting PAHPA Act of 2023
Civil actions and liabilityConsumer affairsGovernment information and archivesPrescription drugs

Ensuring Access to Lifesaving Drugs Act of 2023

USA118th CongressHR-3793| House 
| Updated: 6/9/2023
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jun 5, 2023
Introduced in House
Jun 5, 2023
Referred to the House Committee on Energy and Commerce.
Jun 9, 2023
Referred to the Subcommittee on Health.
  • June 5, 2023
    Introduced in House


  • June 5, 2023
    Referred to the House Committee on Energy and Commerce.


  • June 9, 2023
    Referred to the Subcommittee on Health.
Elissa Slotkin

Elissa Slotkin

Democratic Representative

Michigan

Cosponsors (2)
Scott H. Peters (Democratic)John P. Sarbanes (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 118-4697: Protecting PAHPA Act of 2023
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Civil actions and liabilityConsumer affairsGovernment information and archivesPrescription drugs