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Prompt Approval of Safe Generic Drugs Act

USA119th CongressHR-843| House 
| Updated: 1/31/2025
Nanette Diaz Barragán

Nanette Diaz Barragán

Democratic Representative

California

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
This bill amends the Federal Food, Drug, and Cosmetic Act to facilitate the prompt approval of certain drugs, such as generics, by addressing issues related to proprietary safety information. It specifies that a drug will not be considered ineligible for approval or misbranded if its labeling omits safety information, including contraindications or warnings, that is protected by exclusivity periods or patents. This provision aims to prevent delays in market entry for these drugs while ensuring patient safety. The Secretary of Health and Human Services, through the FDA, is still mandated to require the inclusion of any appropriate safety information deemed necessary for the drug's safe use. The bill also clarifies that these changes do not affect the availability or scope of existing exclusivity protections or patent rights, except as explicitly stated.
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Timeline

Bill from Previous Congress

HR 117-2831
Prompt Approval of Safe Generic Drugs Act

Bill from Previous Congress

HR 118-9616
Prompt Approval of Safe Generic Drugs Act
Jan 31, 2025
Introduced in House
Jan 31, 2025
Referred to the House Committee on Energy and Commerce.
  • Bill from Previous Congress

    HR 117-2831
    Prompt Approval of Safe Generic Drugs Act


  • Bill from Previous Congress

    HR 118-9616
    Prompt Approval of Safe Generic Drugs Act


  • January 31, 2025
    Introduced in House


  • January 31, 2025
    Referred to the House Committee on Energy and Commerce.

Health

Drug safety, medical device, and laboratory regulationMarketing and advertising

Prompt Approval of Safe Generic Drugs Act

USA119th CongressHR-843| House 
| Updated: 1/31/2025
This bill amends the Federal Food, Drug, and Cosmetic Act to facilitate the prompt approval of certain drugs, such as generics, by addressing issues related to proprietary safety information. It specifies that a drug will not be considered ineligible for approval or misbranded if its labeling omits safety information, including contraindications or warnings, that is protected by exclusivity periods or patents. This provision aims to prevent delays in market entry for these drugs while ensuring patient safety. The Secretary of Health and Human Services, through the FDA, is still mandated to require the inclusion of any appropriate safety information deemed necessary for the drug's safe use. The bill also clarifies that these changes do not affect the availability or scope of existing exclusivity protections or patent rights, except as explicitly stated.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

HR 117-2831
Prompt Approval of Safe Generic Drugs Act

Bill from Previous Congress

HR 118-9616
Prompt Approval of Safe Generic Drugs Act
Jan 31, 2025
Introduced in House
Jan 31, 2025
Referred to the House Committee on Energy and Commerce.
  • Bill from Previous Congress

    HR 117-2831
    Prompt Approval of Safe Generic Drugs Act


  • Bill from Previous Congress

    HR 118-9616
    Prompt Approval of Safe Generic Drugs Act


  • January 31, 2025
    Introduced in House


  • January 31, 2025
    Referred to the House Committee on Energy and Commerce.
Nanette Diaz Barragán

Nanette Diaz Barragán

Democratic Representative

California

Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationMarketing and advertising