# 119-s-2292: Over-the-Counter Monograph Drug User Fee Amendments

119-s-2292, Over-the-Counter Monograph Drug User Fee Amendments, is a 119th Congress bill sponsored by Sen. Banks, Jim [R-IN] (R-IN); status in_committee; PRIA reads it as touching household money (as of 2026-06-05).

- Canonical: https://policyrisk.com/legislation/119-s-2292
- As of: 2026-06-05
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-2292
- Congress: 119
- Title: Over-the-Counter Monograph Drug User Fee Amendments
- Status: in_committee
- Introduced: 2025-07-15
- Sponsor: Sen. Banks, Jim [R-IN] (R-IN)
- Cosponsors: 3
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-06-05

## 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. - 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.

## Cosponsors (3)

- Sen. Kaine, Tim [D-VA] (D-VA), 2025-07-15T00:00:00.000Z
- Sen. Kim, Andy [D-NJ] (D-NJ), 2025-07-29T00:00:00.000Z
- Sen. Husted, Jon [R-OH] (R-OH), 2025-07-29T00:00:00.000Z

## Provisions PRIA read

- Easier evidence rules for topical drugs: benefit, medium. 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 FDA must issue draft guidance on non-animal testing within one year.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…
- New Rx-to-OTC switch pathway: benefit, medium. 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…
- New OTC facility fees and timing: mixed, medium. 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 FY202…
- More OTC transparency and reports: mixed, low. 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…

## Related bills

- 119-s-1748: Kids Online Safety Act
- 119-s-237: Honoring Our Fallen Heroes Act of 2025
- 119-s-1816: Improving Seniors’ Timely Access to Care Act of 2025
- 119-s-1547: America the Beautiful Act
- 119-s-522: Credit Union Board Modernization Act
- 119-sres-913: A resolution relating to the death of the Honorable Nancy Kassebaum, former United States Senator for the State of Kansas.

## Sources
- [119-s-2292 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/2292)

## Related
- [119-s-1748: Kids Online Safety Act](https://policyrisk.com/legislation/119-s-1748)
- [119-s-237: Honoring Our Fallen Heroes Act of 2025](https://policyrisk.com/legislation/119-s-237)
- [119-s-1816: Improving Seniors’ Timely Access to Care Act of 2025](https://policyrisk.com/legislation/119-s-1816)
- [119-s-1547: America the Beautiful Act](https://policyrisk.com/legislation/119-s-1547)
- [119-s-522: Credit Union Board Modernization Act](https://policyrisk.com/legislation/119-s-522)
- [119-sres-913: A resolution relating to the death of the Honorable Nancy Kassebaum, former Uni…](https://policyrisk.com/legislation/119-sres-913)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-2292 (as of 2026-06-05).