Over-the-Counter Monograph Drug User Fee Amendments
This bill would reform and extend the FDA’s user fee program for over-the-counter (OTC) monograph drugs under the Federal Food, Drug, and Cosmetic Act. It creates and retools fees paid by OTC monograph drug facilities and by sponsors requesting OTC monograph orders, with a multi-year revenue and fee-setting framework through fiscal year 2030. The proposal emphasizes tying fee levels to inflation, direct costs, and certain workload adjustments, and it introduces a one-time workload adjustment based on facility counts and arrears. It also adds a new testing-procedure provision tied to voluntary consensus standards in pharmaceutical quality. In addition to the fee changes, the bill increases reporting requirements, sets sunset dates (2030 for the fee authorities), and preserves existing pre-enactment fees for a transitional period. The overall aim is to fund and streamline FDA activities related to OTC monograph drugs while formalizing timelines and transparency around fee-setting and program goals. Key elements include: (1) a revised authority to assess and collect OTC monograph fees (facility fees and order-request fees) with specific payment timelines; (2) a detailed, multi-year revenue and adjustment formula (inflation, operating reserves, direct costs, and staffing/workload adjustments); (3) a one-time workload adjustment option for certain years; (4) enhanced performance reporting and metrics starting in 2026; (5) sunset and savings clauses to wind down the program if not renewed, with a transition path from current law.
Key Points
- 1Establishment and extension of OTC monograph user fees, including facility fees for OTC monograph drug facilities and fees for OTC monograph order requests, with specific due dates and payment schedules through fiscal year 2030.
- 2Testing procedure provision added to definitions, allowing the addition or modification of testing procedures for OTC monograph drugs if the procedure reflects a voluntary consensus standard for pharmaceutical quality and is recognized by FDA through a guidance process (initially published July 2023 or successor).
- 3Detailed multi-year fee setting and revenue framework, including:
- 4- Base revenue, inflation adjustments, operating reserve adjustments, direct cost adjustments, and specified fixed dollar amounts for certain years (e.g., 2026–2028).
- 5- An annual process to set and publish fee revenue amounts, facility fees, and order-request fees in the Federal Register not less than 60 days before the new fiscal year.
- 6- A mechanism for adjusting the base and future-year fees based on prior years and inflation.
- 7One-time facility-fee workload adjustment, available in 2028–2030, with criteria based on average facility counts and arrears rates, and a formula to determine the adjustment amount.
- 8Expanded reporting and reauthorization requirements, including a performance report due within 120 days after each fiscal year and, starting 2026, additional detailed information on order requests, processing timelines, safety activities, and postmarket safety data.
- 9Sunset and savings provisions, limiting the authority to October 1, 2030 (fees) with reporting ending January 31, 2031, and a savings clause preserving pre-enactment law for fiscal years prior to 2026.
- 10Effective date and transitional provisions, with the amendments taking effect in October 2025 (or upon enactment if later), and that OTC monograph fees begin October 1, 2025 regardless of enactment date.