Placed on the Union Calendar, Calendar No. 254.
This bill amends the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee program that funds Food and Drug Administration (FDA) activities for over-the-counter (OTC) monograph drugs. It changes definitions, updates the periods and due dates for assessing facility and order-request fees, specifies revenue targets and several annual adjustments for fiscal years 2026–2030 (including certain fixed dollar additions for FY2026–FY2028), authorizes a one-time facility-fee workload adjustment under specified conditions, and requires annual fee-setting and publication in the Federal Register.
Regulatory funding vs. regulatory expansion: Liberals/centrists emphasize improved FDA oversight and transparency; conservatives emphasize added regulatory burden and federal expansion.
Relative to its intended legislative type, this bill is a well-specified statutory modification of the OTC monograph drug user-fee program that provides detailed mechanisms, timelines, and integration with existing law.
This bill amends the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee program that funds Food and Drug Administration (FDA) activities for over-the-counter (OTC) monograph drugs.
It changes definitions, updates the periods and due dates for assessing facility and order-request fees, specifies revenue targets and several annual adjustments for fiscal years 2026–2030 (including certain fixed dollar additions for FY2026–FY2028), authorizes a one-time facility-fee workload adjustment under specified conditions, and requires annual fee-setting and publication in the Federal Register.
The bill recognizes voluntary consensus standards for pharmaceutical quality when adding or modifying testing procedures, makes limited technical corrections to provisions on development advice for certain nonprescription drugs, and sets an effective date for fee assessment (October 1, 2025) and statutory sunsets for the authorization (October 1, 2030) and reporting (January 31, 2031).
Content is technical, narrowly focused, and designed to continue an existing user-fee funding mechanism with sunsets and reporting—features that historically make such bills relatively likely to be enacted. The presence of modest fee increases and procedural links to appropriations could produce negotiation points, but nothing in the text suggests a broad ideological fight that would typically block enactment.
Relative to its intended legislative type, this bill is a well-specified statutory modification of the OTC monograph drug user-fee program that provides detailed mechanisms, timelines, and integration with existing law.
Regulatory funding vs. regulatory expansion: Liberals/centrists emphasize improved FDA oversight and transparency; conservatives emphasize added regulatory burden and federal expansion.
These are examples from the analysis, not a ranked list of the most-affected groups.
Regulatory funding vs. regulatory expansion: Liberals/centrists emphasize improved FDA oversight and transparency; conservatives emphasize added regulatory burden and federal expansion.
A mainstream liberal would likely view this bill as a pragmatic way to ensure the FDA has dedicated resources to oversee OTC monograph drugs, improving consumer safety and regulatory capacity.
They would welcome the explicit dedication of fee revenue to OTC activities, the requirement to publish fees annually, and the recognition of voluntary consensus standards for testing as a quality safeguard.
They would also be wary of overreliance on user fees creating regulatory capture or distorted priorities favoring industry, and would note the temporary nature of the authorization (sunset in 2030) as an opportunity to reassess outcomes.
A pragmatic centrist would generally view the bill positively as a targeted update that provides predictable funding to support FDA oversight of OTC monograph drugs while building in transparency and a sunset to reassess the program.
They would appreciate the specified timelines for fee assessment, the publication requirement, and mechanics for inflation and workload adjustments.
They would also watch for clear cost estimates and administrative clarity, and want assurances that the bill avoids sudden fee spikes or poorly justified adjustments.
A mainstream conservative would view this bill with skepticism about expanding or locking in steady funding streams that enable federal regulatory activity, even though the program is funded by user fees rather than general revenues.
They would be concerned about additional costs on domestic producers, potential regulatory overreach, and increased federal dependency on industry fees.
They would also note the sunset provision but remain wary of the overall expansion of FDA authority and administrative complexity.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
Content is technical, narrowly focused, and designed to continue an existing user-fee funding mechanism with sunsets and reporting—features that historically make such bills relatively likely to be enacted. The presence of modest fee increases and procedural links to appropriations could produce negotiation points, but nothing in the text suggests a broad ideological fight that would typically block enactment.
The bill has not accumulated any surfaced votes yet.
Regulatory funding vs. regulatory expansion: Liberals/centrists emphasize improved FDA oversight and transparency; conservatives emphasize…
Content is technical, narrowly focused, and designed to continue an existing user-fee funding mechanism with sunsets and reporting—features…
Relative to its intended legislative type, this bill is a well-specified statutory modification of the OTC monograph drug user-fee program that provides detailed mechanisms, timelines, and integration with existing law.
Go beyond the headline summary with full stakeholder mapping, legislative design analysis, passage barriers, and lens-by-lens tradeoff breakdowns.