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ACCESS Through OTC Innovation Act

USA119th CongressHR-6868| House 
| Updated: 12/18/2025
Greg Landsman

Greg Landsman

Democratic Representative

Ohio

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to apply the least burdensome appropriate means when evaluating requests to determine if over-the-counter (OTC) monograph drugs are generally recognized as safe and effective. Specifically, for administrative order requests concerning OTC drugs, the Secretary must ensure that the methods for supporting such requests are as efficient and straightforward as possible. If existing published reports are insufficient to support a request, the bill mandates that the Secretary meet with the requestor, upon a reasonable written request, to provide recommendations on the types of evidence needed. These recommendations may include guidance on the potential design and size of studies required to demonstrate that the drug is safe and effective. The Secretary is also required to prepare and make available meeting minutes and incorporate written recommendations into the administrative record, without altering the fundamental criteria for drug safety and effectiveness.
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Timeline
Dec 18, 2025
Introduced in House
Dec 18, 2025
Referred to the House Committee on Energy and Commerce.
  • December 18, 2025
    Introduced in House


  • December 18, 2025
    Referred to the House Committee on Energy and Commerce.

Health

ACCESS Through OTC Innovation Act

USA119th CongressHR-6868| House 
| Updated: 12/18/2025
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to apply the least burdensome appropriate means when evaluating requests to determine if over-the-counter (OTC) monograph drugs are generally recognized as safe and effective. Specifically, for administrative order requests concerning OTC drugs, the Secretary must ensure that the methods for supporting such requests are as efficient and straightforward as possible. If existing published reports are insufficient to support a request, the bill mandates that the Secretary meet with the requestor, upon a reasonable written request, to provide recommendations on the types of evidence needed. These recommendations may include guidance on the potential design and size of studies required to demonstrate that the drug is safe and effective. The Secretary is also required to prepare and make available meeting minutes and incorporate written recommendations into the administrative record, without altering the fundamental criteria for drug safety and effectiveness.
View Full Text

Suggested Questions

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

Timeline
Dec 18, 2025
Introduced in House
Dec 18, 2025
Referred to the House Committee on Energy and Commerce.
  • December 18, 2025
    Introduced in House


  • December 18, 2025
    Referred to the House Committee on Energy and Commerce.
Greg Landsman

Greg Landsman

Democratic Representative

Ohio

Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted