Bill · S. 2513· Senate(119-S-2513)
OTC Monograph Drug User Fee Transparency Act
- Introduced
- 7/29/2025
- Last activity
- 7/29/2025 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Sponsored by
- Timothy Kaine
- Cosponsors
- None
- Introduced
- In Committee
What this bill would do
This bill is called the OTC Monograph Drug User Fee Transparency Act. It requires the Food and Drug Administration to include a lot more details in its annual performance reports starting in fiscal year 2026. These new details cover things like the progress made on order requests, processing timelines, and postmarket safety activities. It also forces the Food and Drug Administration to put detailed minutes of negotiation meetings online within 30 days. Lastly, it orders the Government Accountability Office to submit a report within two years that assesses the supply chain of over-the-counter monograph drugs.
Yes· 3 of 5
Does this make what the government does easier for the public to see?+4
The bill significantly improves government transparency by mandating detailed FDA performance reports and the public posting of negotiation meeting minutes.
Does this make health care easier to get in general?+2
By requiring a GAO report on OTC drug supply chains and mitigating disruptions, the bill helps ensure essential medicines remain available to the public.
Does this give people more protection from unfair business practices?+2
The bill enhances transparency and monitoring in the OTC drug market, indirectly protecting consumers through better regulatory oversight.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
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Section 2(a), adding subsection (a)(2) to section 744N: This provision requires the Food and Drug Administration to report on its progress with order requests, processing timelines, and postmarket safety activities like reviewing adverse event reports. This is positive because it holds the government accountable and lets the public see how well the Food and Drug Administration is managing over-the-counter drugs.
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Section 2(a), adding subsection (d)(4) to section 744N: This requires the Food and Drug Administration to publish robust written minutes of all negotiation meetings with the regulated industry on its website within 30 days. This is a big win for transparency, allowing everyday people to see what deals or discussions are happening behind closed doors between regulators and drug companies.
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Section 2(b): This orders the Comptroller General to submit a report within two years assessing the supply chain stability of over-the-counter monograph drugs. This is beneficial because it looks at how the Food and Drug Administration monitors and mitigates supply chain disruptions, which helps ensure store shelves stay stocked with the medicines people need.
Potential Negative Impacts for People
Based on the provided text, there are no specific sections or provisions identified that create negative consequences or burdens for individuals or groups of people in the United States.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Governance And Ideology
- Improves Government Transparency+4Increases Federal Power+1
- Healthcare
- Improves Healthcare Access+2Improves Pandemic Preparedness+1
- Economy And Finance
- Improves Consumer Protection+2
- 7/29/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Introduced in Senate