Sponsors (4)
The bill provides stable, transparent funding and clearer regulatory pathways to speed OTC drug availability and oversight, but it shifts substantial costs onto regulated firms and consumers, increases administrative and implementation burdens, and raises trade-offs between faster access and potential safety, confidentiality, and flexibility risks.
Patients (including people with chronic conditions, seniors, and children) will gain faster and broader access to certain safe nonprescription (OTC) drugs because the bill creates clearer switch pathways, allows real-world evidence, and funds OTC monograph activities.
FDA will have a more predictable revenue stream and explicit fee schedules (including set targets and publication requirements), stabilizing funding for OTC monograph work and other review activities.
Consumers, providers, and policymakers will get better transparency and oversight through required reporting (fee amounts, timelines for proposed/final orders, postmarket safety analytics, GAO supply-chain review, and Congressional Record entries).
Manufacturers, facilities (including small manufacturers and contract labs), and ultimately consumers will face higher costs because the bill raises fee revenue targets, includes one-time fee additions, and makes fees effective starting Oct 1, 2025.
Patients and the public could face increased safety uncertainty because allowing real-world evidence, broader evidence standards, and reliance on nonclinical/consensus tests may lower premarket evidentiary thresholds and increase misuse or need for extensive postmarket monitoring.
FDA, GAO, and regulated firms will incur significant additional administrative burdens (collecting and publishing expanded metrics, meeting minutes, and running new processes), which could divert agency resources and delay other regulatory or enforcement activities if staffing/resources are not increased.
Based on analysis of 10 sections of legislative text.
Revises FDA OTC monograph user‑fee timing and formulas; sets evidence/testing standards for topical OTC actives, Rx‑to‑OTC procedures, reporting, and sunsets the fee authority.
Official title: 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 15, 2025 by James E. Banks · Last progress July 15, 2025
Updates how the FDA manages and collects user fees for over‑the‑counter (OTC) monograph drugs, establishes clearer testing and evidence standards for topical nonprescription actives (including sunscreens), creates predictable procedures for converting prescription drugs to nonprescription status, expands annual FDA reporting on OTC activities, and sets sunsets for the user‑fee authorities. It also sets effective dates and specific fee assessment periods and formulas for FY2026–FY2030 so facility fees are collected on a defined schedule beginning October 1, 2025. The bill adds new statutory language to allow real‑world evidence and non‑animal testing alternatives when appropriate for topical OTC actives, requires FDA guidance and reporting on testing/implementation, directs the agency to provide clearer processes for Rx‑to‑OTC switches (including guidance and stakeholder engagement), and sunsets the OTC user‑fee program in 2030–2031 unless reauthorized.