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OTC Monograph Drug User Fee Transparency Act

USA119th CongressS-2513| Senate 
| Updated: 7/29/2025
Tim Kaine

Tim Kaine

Democratic Senator

Virginia

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
This legislation, titled the "OTC Monograph Drug User Fee Transparency Act," amends the Federal Food, Drug, and Cosmetic Act to significantly increase transparency regarding over-the-counter (OTC) drug monograph activities. Starting in fiscal year 2026, the Food and Drug Administration's (FDA) annual performance report must include detailed information on the progress and future plans for achieving its goals. This includes specific metrics such as the number of various types of OTC monograph order requests (Tier 1, Tier 2, specified safety, and generally recognized as safe and effective finalization) for which proposed and final orders were issued, along with their average processing timelines. Furthermore, the annual report will require information on postmarket safety activities for OTC monograph drugs, including adverse event reporting and the development of analytical tools. It also mandates reporting on the registration and fee payment status of OTC monograph drug facilities and contract manufacturing organizations. The bill also requires the FDA to make publicly available robust written minutes of all negotiation meetings with the regulated industry within 30 days, detailing substantive proposals and significant controversies. Finally, it directs the Comptroller General to submit a report within two years assessing the stability and characteristics of the OTC monograph drug supply chain, including how the FDA collects and uses relevant information and coordinates with other federal agencies.
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Timeline
Jul 29, 2025
Introduced in Senate
Jul 29, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • July 29, 2025
    Introduced in Senate


  • July 29, 2025
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

OTC Monograph Drug User Fee Transparency Act

USA119th CongressS-2513| Senate 
| Updated: 7/29/2025
This legislation, titled the "OTC Monograph Drug User Fee Transparency Act," amends the Federal Food, Drug, and Cosmetic Act to significantly increase transparency regarding over-the-counter (OTC) drug monograph activities. Starting in fiscal year 2026, the Food and Drug Administration's (FDA) annual performance report must include detailed information on the progress and future plans for achieving its goals. This includes specific metrics such as the number of various types of OTC monograph order requests (Tier 1, Tier 2, specified safety, and generally recognized as safe and effective finalization) for which proposed and final orders were issued, along with their average processing timelines. Furthermore, the annual report will require information on postmarket safety activities for OTC monograph drugs, including adverse event reporting and the development of analytical tools. It also mandates reporting on the registration and fee payment status of OTC monograph drug facilities and contract manufacturing organizations. The bill also requires the FDA to make publicly available robust written minutes of all negotiation meetings with the regulated industry within 30 days, detailing substantive proposals and significant controversies. Finally, it directs the Comptroller General to submit a report within two years assessing the stability and characteristics of the OTC monograph drug supply chain, including how the FDA collects and uses relevant information and coordinates with other federal agencies.
View Full Text

Suggested Questions

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Timeline
Jul 29, 2025
Introduced in Senate
Jul 29, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • July 29, 2025
    Introduced in Senate


  • July 29, 2025
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Tim Kaine

Tim Kaine

Democratic Senator

Virginia

Health, Education, Labor, and Pensions Committee

Health

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