Over-the-Counter Monograph Drug User Fee Amendments
H.R. 4273 would revise and extend the federal program that collects user fees from industry to support the regulation of over-the-counter (OTC) monograph drugs. The bill modernizes how fees are assessed and paid, updates the period and amount calculations for fiscal years 2026–2030, and adds a one-time workload adjustment mechanism. It clarifies that the collected fees fund OTC monograph activities, introduces a testing standard based on voluntary consensus standards for pharmaceutical quality, and expands who may participate in certain regulatory discussions related to nonprescription drugs marketed without an approved drug application. The bill also sets a sunset for the fee program (October 1, 2030) and requires annual reporting, with related savings provisions preserving the current regime for pre-2026 fees. An effective date is established to begin implementing changes in fall 2025, with fee collection commencing October 1, 2025. In short, the bill reshapes funding, governance, and procedural aspects of OTC monograph regulation to ensure ongoing oversight, modernization of testing standards, and clearer reporting, while providing a defined sunset and transitional controls.
Key Points
- 1New testing standard provision: Adds a testing procedure for OTC monograph drugs that reflects a voluntary consensus standard for pharmaceutical quality, recognized by the Secretary through FDA industry guidance (initially published July 2023 or successor guidance).
- 2Revised fee authority and timing: Updates how OTC monograph facility fees and OTC monograph order request fees are assessed, with new applicable periods for fiscal years 2026–2030 (defining the period for which fees are due rather than tying them to a specific date in December).
- 3Revenue amounts and adjustments: For 2026–2030, sets total fee revenue to include base revenue, inflation adjustments, operating reserves (if applicable), additional direct costs, and specified additional fixed amounts. Also introduces a one-time facility fee workload adjustment for certain conditions in 2028–2030.
- 4Annual fee setting and publication: Requires the Secretary to set and publish the fee revenues and associated facility and order-request fees not later than 60 days before the start of each fiscal year.
- 5Sunset and reporting: The authority to collect and regulate OTC monograph fees would terminate on October 1, 2030, with related reporting obligations ending January 31, 2031; pre-2026 provisions would be preserved only to the extent they apply to years prior to 2026.
- 6Regulatory process updates for nonprescription drugs: Expands the scope of who can receive development advice for nonprescription drugs marketed without an approved drug application to include organizations nominated by sponsors or requestors to represent their interests, and makes a minor technical correction to align terminology.