Sponsors (4)
The bill provides dedicated, more predictable funding and regulatory pathways to speed OTC monograph modernization and product updates, but does so by imposing fees and procedural changes that raise costs, add administrative complexity, reduce some budgetary flexibility, and introduce transparency and oversight risks.
Patients, hospitals, and manufacturers will see more predictable and dedicated FDA funding for OTC monograph review, improving FDA capacity to modernize review processes and support product safety/availability.
Manufacturers, pharmacies, and health systems can use recognized consensus testing standards without triggering the slower administrative order process, allowing faster product quality updates and modernization of OTC products.
Small businesses, manufacturers, and budget officers will get clearer, more predictable fee timing and formula rules (including staggered payments in one year), which aids cash-flow planning and transparency about how fees are set.
Patients, consumers, and small manufacturers may face higher costs because new or increased user fees on OTC monograph drugs can raise manufacturers' costs that are often passed through to consumers.
State governments and taxpayers could lose budget flexibility because dedicating fee revenue to a specific FDA program limits HHS's ability to shift funds to other health priorities.
Regulated businesses and consumers could face safety and approval disruptions if authorities or requirements created by these provisions sunset or lapse, creating uncertainty in oversight and protections.
Based on analysis of 9 sections of legislative text.
Revises and funds the FDA over‑the‑counter (OTC) monograph user‑fee program by changing fee assessment periods, due dates, revenue formulas, reporting rules, and certain procedural exclusions.
Official title: To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter monograph drugs, and for other purposes.
Introduced July 2, 2025 by Robert E. Latta · Last progress July 2, 2025
Creates and updates the user-fee program for over-the-counter (OTC) monograph drugs: it changes which testing standards are excluded from the administrative order process, revises timing and billing rules for facility and program fees for FY2026–FY2030, adjusts annual reporting language, expands who may receive FDA development advice, and sets multi-year expirations and effective dates. The bill directs how fee revenue is set and adjusted, when fees are due (including phased rules for FY2026–FY2028+), and preserves the prior law for assessing fees before FY2026.