Bill · S. 2292· Senate(119-S-2292)
Over-the-Counter Monograph Drug User Fee Amendments
- Introduced
- 7/15/2025
- Last activity
- 9/8/2025 — Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
- Sponsored by
- Jim Banks
- Cosponsors
- - 1 - 2
- Introduced
- On Calendar
What this bill would do
This bill amends the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter (OTC) monograph drugs. It establishes new fee structures, due dates, and revenue amounts for fiscal years 2026 through 2030. The legislation also updates definitions regarding testing procedures and provides new standards for evaluating active ingredients for topical administration. Additionally, it creates a process for "Rx-to-nonprescription switches" to increase predictability for drug developers. Finally, the bill mandates various reporting requirements and GAO assessments regarding the drug supply chain and application processes.
Yes
Does this make what the government does easier for the public to see?+6
The bill requires the publication of negotiation meeting minutes and annual performance reports to increase transparency.
Does this give people more protection from unfair business practices?+5
The bill enhances consumer protection by increasing transparency in FDA negotiations and improving oversight of the OTC drug supply chain.
Does this make health care easier to get in general?+3
The bill aims to improve access to medications by streamlining the process for prescription-to-OTC switches.
The opposite
Would business owners be better off under this?-3
The bill imposes new facility fees and potential workload adjustments on drug developers and manufacturers.
Who it would affect, and how
Potential Positive Impacts for People
-
Improved Standards for Topical Drugs: The Secretary is directed to utilize standards that allow for "real world evidence" to supplement traditional clinical trials when evaluating active ingredients for topical administration (Section 6, Subsection (a)(1)(A)).
-
Reduction in Animal Testing: The bill directs the Secretary to consider nonclinical testing alternatives to animal testing for drugs intended for topical administration (Section 6, Subsection (a)(2)(A)).
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Increased Predictability for Prescription-to-OTC Switches: The bill establishes a process where persons planning an "Rx-to-nonprescription switch" can request meetings with the Secretary to develop plans, which aims to increase clarity and predictability (Section 7, Subsection (a)(7)(A)).
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Enhanced Transparency: The Secretary is required to make "robust written minutes" of negotiation meetings between the FDA and the regulated industry publicly available (Section 5, Subsection (a)(4)(A)).
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Supply Chain Oversight: The bill mandates a GAO report to assess the overall stability of the supply chain for over-the-counter monograph drugs (Section 5, Subsection (b)(1)).
Potential Negative Impacts for People
-
New Financial Obligations for Facilities: The bill establishes a system of facility fees that must be paid by persons engaged in activities related to OTC monograph drugs (Section 4, Subsection (a)).
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Potential for Increased Fees: The revenue amounts include various adjustments, such as inflation adjustments, operating reserve adjustments, and additional direct cost adjustments (Section 4, Subsection (b)(1)).
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One-time Workload Adjustments: The Secretary has the authority to implement a one-time facility fee workload adjustment for fiscal years 2028, 2029, or 2030 (Section 4, Subsection (c)(4)).
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+6
- Economy And Finance
- Improves Consumer Protection+5
- Demographic And Interest Groups
- Good For Business Owners-3
- Healthcare
- Improves Healthcare Access+3
- 9/8/2025
- Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
- 7/30/2025
- Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- 7/29/2025
- 2 Cosponsors added.
- 7/15/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 1 Cosponsor added.
- Introduced in Senate
2 bills Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Jon HustedRepublican · Ohio
Timothy KaineDemocrat · Virginia
Andy KimDemocrat · New Jersey