Over-the-Counter Monograph Drug User Fee Amendments
Sponsored By: Representative Latta
In Committee
Summary
Reauthorizes and restructures user fees for over-the-counter (OTC) monograph drugs through 2030. It changes how the FDA sets and collects facility and order fees, ties fee revenue to specific OTC monograph activities and testing standards, and expands who can get development and technical advice.
Show full summary
- Drug manufacturers and facilities: face new, explicit fee schedules and eligibility windows for facility and order fees covering FY2026–2030, with specific due dates and a phased payment option in FY2027.
- FDA funding and operations: fees are dedicated to OTC monograph work and use a new fee formula that adds base revenue, inflation and reserve adjustments, fixed-dollar amounts, and a possible one-time workload boost if facilities exceed 1,625.
- Sponsors and representatives: organizations nominated by sponsors can now receive development and technical advice and represent sponsors in proceedings, broadening stakeholder participation.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Exemptions and sunset for OTC fees
If enacted, firms would avoid facility fees only if they stopped all OTC monograph work before set dates. For FY2026 the cutoff is before January 1, 2025; for FY2027, before January 1, 2026; for FY2028 and later, before October 1 of the prior fiscal year. Fees for years before FY2026 would stay under the old rules. The OTC fee program’s legal authority would end on October 1, 2030.
Clear testing standards and broader FDA advice
This bill would treat new or changed testing procedures as covered if they follow voluntary consensus quality standards that FDA recognizes in guidance first issued in July 2023 (or later guidance). It would also let organizations nominated by a sponsor get FDA development advice for nonprescription drugs.
New formulas and due dates for OTC fees
This bill would set how OTC facility fees are calculated for FY2026–FY2030. Fees would add base revenue, inflation, reserve and cost adjustments, plus fixed amounts ($2.373 million in FY2026; $1.233 million in FY2027; $0.854 million in FY2028). A one-time increase could apply in FY2028–FY2030 if the 3‑year average facility count is above 1,625 and fewer than 30% are in arrears. It would also fix assessment periods and payment dates: FY2026 fees due by early June 2026 (or after an appropriations act), FY2027 in two payments (around Oct 2026 and Feb 1, 2027, or after appropriations), and FY2028+ on or after Oct 1 (or after appropriations). FDA would publish the annual fee amounts at least 60 days before each fiscal year.
Sponsors & CoSponsors
Sponsor
Latta
OH • R
Cosponsors
Rep. DeGette, Diana [D-CO-1]
CO • D
Sponsored 7/2/2025
Crenshaw
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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