Over-the-Counter Monograph Drug User Fee Amendments

Bill Number: S. 2292
Origin Chamber: Senate
Congress: 119th Congress, Session 1
Policy Area: Health
Status: Introduced
Latest Action: 2025-09-08: Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
Last Updated: 2026-06-03T21:04:50Z

AI-Generated Summary

Purpose This legislation revises and extends the user fee program for over-the-counter (OTC) monograph drugs under the Federal Food, Drug, and Cosmetic Act. It aims to fund FDA activities related to these drugs through fiscal year 2030, update fee structures, enhance regulatory processes for topical active ingredients, and improve predictability for switching prescription drugs to nonprescription status.

Key Provisions

Fee Program Updates: Establishes facility fee revenue targets for fiscal years 2026–2030, incorporating base revenue, inflation adjustments, operating reserve adjustments, direct cost adjustments, and limited one-time workload adjustments.
Fee Assessment Changes: Modifies the periods for assessing facility fees, updates due dates (including split payments for fiscal year 2027), and clarifies exemptions for facilities that cease OTC monograph activities.
Definitions Expansion: Adds a new category for modifications to testing procedures that align with recognized voluntary consensus standards for pharmaceutical quality.
Enhanced Reporting: Requires annual FDA performance reports with detailed metrics on OTC monograph order requests by tier, facility registrations, evidence standards application, and postmarket safety activities; mandates public meeting minutes from industry negotiations.
Topical Active Ingredients: Directs use of real-world evidence and non-animal testing methods in safety and effectiveness evaluations for drugs intended for topical administration; requires updated guidance on these alternatives.
Rx-to-Nonprescription Switches: Establishes a structured meeting process for sponsors, requires new FDA guidance on approval standards and evidence, and mandates a public stakeholder engagement plan.
GAO Reports: Requires assessments of the OTC monograph drug supply chain and Rx-to-nonprescription switch processes.
Sunset and Savings: Extends program authority through September 30, 2030, with reporting requirements ending January 31, 2031; preserves prior fee rules for earlier fiscal years.

Significant Changes to Existing Law

Extends the OTC monograph user fee program from the prior 2025 sunset to 2030.
Introduces new subsection (r) to section 505G for evidence and testing standards specific to topical ingredients.
Adds paragraph (7) to section 505(b) outlining procedures and guidance for Rx-to-nonprescription switch applications.
Updates fee revenue calculations, adjustment mechanisms, and due date structures in sections 744L, 744M, and 744N.
Requires additional detailed reporting elements and public disclosure of negotiation minutes.

Potential Impacts

Government Agencies: Provides the FDA with stable funding and clearer operational guidelines; increases administrative workload through expanded reporting, new guidance development, and stakeholder engagement.
Citizens: May facilitate development of additional OTC products, including topical treatments, and improve access to switched medications with enhanced consumer self-selection tools.
International Relations: Limited direct effects; alignment with voluntary consensus standards could support consistency with international pharmaceutical quality norms.
Industry: Offers more predictable fee schedules and regulatory pathways while maintaining fee obligations.

Main Stakeholders Affected

OTC monograph drug manufacturers and contract manufacturing organizations (fee payers and registration requirements).
The Food and Drug Administration (program administration and new review standards).
Sponsors seeking Rx-to-nonprescription switches.
Consumers (potential access to more nonprescription options).
Congress (oversight through required reports and reauthorization).

Notable Legal, Constitutional, or Political Implications The bill contains no apparent constitutional conflicts and follows established patterns for FDA user fee reauthorizations. It emphasizes transparency through public minutes and reports while protecting confidential commercial information. The inclusion of real-world evidence and non-animal testing reflects evolving regulatory science without altering core safety and effectiveness standards.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Sen. Banks, Jim [R-IN]

Cosponsors (3)

Sen. Kaine, Tim [D-VA], Sen. Kim, Andy [D-NJ], Sen. Husted, Jon [R-OH]

Recent Actions

2025-09-08: Placed on Senate Legislative Calendar under General Orders. Calendar No. 152.
2025-09-08: Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
2025-09-08: Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
2025-07-30: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
2025-07-15: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
2025-07-15: Introduced in Senate

Bill Versions

Over-the-Counter Monograph Drug User Fee Amendments — issued 2025-07-15 — PDF (16 pages)
Over-the-Counter Monograph Drug User Fee Amendments — issued 2025-09-08 — PDF (48 pages)