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119-s-2292119th CongressWALLET

Over-the-Counter Monograph Drug User Fee Amendments

Sponsored By: Senator Banks, Jim [R-IN]

In Committee

Summary

Creates a multi-year OTC monograph user-fee funding framework to fund FDA review of over-the-counter drugs. It also formalizes a pathway for prescription drugs to switch to nonprescription status and updates evidence standards for topical ingredients and sunscreens.

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  • Consumers and patients: Establishes a formal Rx-to-nonprescription switch pathway with mandatory guidance to improve predictability and require documented meetings and plans. The agency must publish a stakeholder engagement plan within 1 year and issue required guidance within 18 months.
  • Industry and manufacturers: Reframes fees through FY2026–FY2030 with facility fees and order-request fees, year-by-year revenue targets, phased payment schedules, and a one-time workload adjustment tied to historical facility counts and arrears.
  • Regulators and oversight: Requires expanded annual performance reports beginning FY2026, must be submitted within 120 days after each fiscal year end, public minutes of fee-negotiation meetings, and GAO assessments of the OTC supply chain and of Rx-to-nonprescription metrics.

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Bill Overview

Analyzed Economic Effects

4 provisions identified: 2 benefits, 0 costs, 2 mixed.

Easier evidence rules for topical drugs

If enacted, FDA could use real-world evidence and accept non-animal testing alternatives when evaluating topical nonprescription active ingredients. FDA must issue draft guidance on non-animal testing within one year. The bill would treat testing methods that follow voluntary consensus standards as covered procedures. Final sunscreen orders must use historical safety data, consider SPF 15+ broad‑spectrum benefits, and follow the new evidence rules.

New Rx-to-OTC switch pathway

If enacted, sponsors planning to request a prescription‑to‑nonprescription switch could ask FDA for a written meeting to develop a plan and study design. FDA would document each meeting and must issue binding guidance within 18 months on evidentiary standards, label comprehension, and tools beyond the Drug Facts Label. FDA would also publish a stakeholder engagement plan within one year to identify switch candidates.

New OTC facility fees and timing

If enacted, the bill would make FDA set and publish annual OTC facility and order-request fees for FY2026–FY2030 using a specific formula. The formula would add inflation, reserve and direct-cost adjustments, and fixed dollar add-ons ($2,373,000 for FY2026; $1,233,000 for FY2027; $854,000 for FY2028). FDA could apply a one-time workload increase if average facility counts exceed 1,625 and arrears are under 30%. The bill would also change fee assessment periods and due dates and require fees to be set 60 days before each fiscal year. The statutory fee authority would end on October 1, 2030.

More OTC transparency and reports

If enacted, FDA would have to publish a yearly performance report within 120 days after each fiscal year, starting with FY2026. FDA would also post written minutes of fee-negotiation meetings within 30 days. The Government Accountability Office would have one year to report on Rx-to-nonprescription switch activity since Oct 1, 2022. The statute's specific reporting mandate would end on Jan 31, 2031.

Sponsors & CoSponsors

Sponsor

Banks, Jim [R-IN]

IN • R

Cosponsors

  • Sen. Kaine, Tim [D-VA]

    VA • D

    Sponsored 7/15/2025

  • Sen. Kim, Andy [D-NJ]

    NJ • D

    Sponsored 7/29/2025

  • Sen. Husted, Jon [R-OH]

    OH • R

    Sponsored 7/29/2025

Roll Call Votes

No roll call votes available for this bill.

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