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119-hr-4273119th CongressWALLET

Over-the-Counter Monograph Drug User Fee Amendments

Sponsored By: Representative Latta, Robert E. [R-OH-5]

In Committee

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.

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  • 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.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 1 benefits, 0 costs, 1 mixed.

Higher OTC facility fees for drug makers

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, $1.233 million for FY2027, and $854,000 for FY2028 and lists direct-cost adjustments for FY2026–FY2030. It would allow a one-time workload adjustment in 2028–2030 if specific facility-count and arrears tests are met. Fees would be assessed beginning October 1, 2025, and the Secretary must publish fees at least 60 days before each fiscal year. The statutory fee authority would end October 1, 2030, and the related reporting authority would end January 31, 2031. The bill would also preserve pre-enactment fee rules for any fees that cover years before FY2026.

New FDA testing and advice rules

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 monograph user-fee report within 120 days after each fiscal year and update related year references. These are procedural changes to testing, meetings, and reporting that affect manufacturers and sponsors.

Sponsors & CoSponsors

Sponsor

Latta, Robert E. [R-OH-5]

OH • R

Cosponsors

  • Rep. DeGette, Diana [D-CO-1]

    CO • D

    Sponsored 7/2/2025

  • Rep. Crenshaw, Dan [R-TX-2]

    TX • R

    Sponsored 7/2/2025

  • Rep. Dingell, Debbie [D-MI-6]

    MI • D

    Sponsored 7/2/2025

Roll Call Votes

No roll call votes available for this bill.

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