# 119-hr-4273: Over-the-Counter Monograph Drug User Fee Amendments

119-hr-4273, Over-the-Counter Monograph Drug User Fee Amendments, is a 119th Congress bill sponsored by Rep. Latta, Robert E. [R-OH-5] (R-OH); status in_committee; PRIA reads it as touching household money (as of 2026-07-19).

- Canonical: https://policyrisk.com/legislation/119-hr-4273
- As of: 2026-07-19
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-4273
- Congress: 119
- Title: Over-the-Counter Monograph Drug User Fee Amendments
- Status: in_committee
- Introduced: 2025-07-02
- Sponsor: Rep. Latta, Robert E. [R-OH-5] (R-OH)
- Cosponsors: 3
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-07-19

## Summary

**Modernizes the OTC monograph user fee program** to create clear fee periods, revenue formulas, and broader stakeholder input for nonprescription drugs. It restructures how facilities and order requests are charged and recognizes new testing standards. - Manufacturers and facilities: Moves fee timing from calendar years to defined assessment periods, sets due dates and installment options for FY 2026 and FY 2027, and renames a Washington region that affects regional fee calculations. - FDA and fee revenue: Establishes a formula for annual fee revenue made of base revenue, inflation and reserve adjustments, additional fixed amounts for early years, and a possible one-time workload adjustment under specific conditions. The Secretary must set and publish fees at least 60 days before each fiscal year. - Sponsors and standards bodies: Broadens who can supply development advice by allowing organizations nominated by sponsors or requestors and expands definitions to include voluntary consensus testing standards recognized by the Secretary.

## Cosponsors (3)

- Rep. DeGette, Diana [D-CO-1] (D-CO), 2025-07-02T00:00:00.000Z
- Rep. Crenshaw, Dan [R-TX-2] (R-TX), 2025-07-02T00:00:00.000Z
- Rep. Dingell, Debbie [D-MI-6] (D-MI), 2025-07-02T00:00:00.000Z

## Provisions PRIA read

- New FDA testing and advice rules: benefit, low. This bill would let FDA recognize voluntary consensus testing standards for OTC monograph drugs, starting October 1, 2025. It would let organizations nominated by sponsors represent those sponsors in development-advice meetings for nonprescription drugs. It would also require FDA's annual OTC monog…
- Higher OTC facility fees for drug makers: mixed, medium. This bill would change how FDA sets and collects OTC monograph facility and order-request fees for FY2026–FY2030. Each year's total facility fee would start with a base revenue and add inflation, reserve, and direct-cost adjustments. The bill adds extra fixed amounts of $2.373 million for FY2026, $…

## Related bills

- 119-hr-3151: SHIPS for America Act of 2025
- 119-hr-4382: America’s Olympic and Paralympic Games Commemorative Coins Act
- 119-hr-1628: 761st Tank Battalion Congressional Gold Medal Act
- 119-hr-1502: North Platte Canteen Congressional Gold Medal Act
- 119-hr-452: Miracle on Ice Congressional Gold Medal Act
- 119-hr-4398: Veteran Burial Timeliness and Death Certificate Accountability Act

## Sources
- [119-hr-4273 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/4273)

## Related
- [119-hr-3151: SHIPS for America Act of 2025](https://policyrisk.com/legislation/119-hr-3151)
- [119-hr-4382: America’s Olympic and Paralympic Games Commemorative Coins Act](https://policyrisk.com/legislation/119-hr-4382)
- [119-hr-1628: 761st Tank Battalion Congressional Gold Medal Act](https://policyrisk.com/legislation/119-hr-1628)
- [119-hr-1502: North Platte Canteen Congressional Gold Medal Act](https://policyrisk.com/legislation/119-hr-1502)
- [119-hr-452: Miracle on Ice Congressional Gold Medal Act](https://policyrisk.com/legislation/119-hr-452)
- [119-hr-4398: Veteran Burial Timeliness and Death Certificate Accountability Act](https://policyrisk.com/legislation/119-hr-4398)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-4273 (as of 2026-07-19).