OTC Monograph Drug User Fee Transparency Act

Bill Number: S. 2513
Origin Chamber: Senate
Congress: 119th Congress, Session 1
Policy Area: Health
Status: Introduced
Latest Action: 2025-07-29: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Last Updated: 2025-09-17T16:39:59Z

AI-Generated Summary

Purpose

The OTC Monograph Drug User Fee Transparency Act (S. 2513) aims to increase transparency and accountability in the Food and Drug Administration's (FDA) management of over-the-counter (OTC) drugs regulated through monographs. These are guidelines that define safe and effective ingredients and labeling for OTC drugs without needing individual approvals. The bill enhances reporting on FDA performance, negotiations with industry, and the supply chain for these drugs.

Key Provisions

Enhanced Annual Performance Reports: Starting in fiscal year 2026, the FDA must include in its yearly report under Section 744N of the Federal Food, Drug, and Cosmetic Act:
Progress on processing different types of OTC monograph order requests (e.g., Tier 1 and Tier 2 requests for proposed or final orders on drug ingredients or uses; specified safety requests; and requests to finalize "generally recognized as safe and effective" status).
Average timelines for handling these requests, broken down by type.
Details on postmarket safety activities for OTC drugs, such as collecting adverse event reports (unwanted side effects), improving data tools and systems, and actions under Section 760 (related to drug safety monitoring).
Information on new registrations and fee payments by OTC drug facilities and contract manufacturing organizations (firms that produce drugs for others).
Public Disclosure of Negotiation Minutes: The FDA must post detailed written summaries of all negotiation meetings with industry on its public website within 30 days. These minutes must cover substantive proposals, major disagreements, and how they were resolved.
GAO Supply Chain Report: Within two years of enactment, the Government Accountability Office (GAO, an independent agency that audits federal programs) must submit a report to Senate and House committees assessing:
The stability of the OTC drug supply chain (the network of production and distribution).
Data collected by the FDA on this supply chain.
How the FDA uses this data for regulatory decisions.
Coordination with other federal agencies to address disruptions.
Unique aspects of the OTC market and any additional powers or information needed to maintain supply stability.
Confidentiality Protections: The new reporting requirements cannot disclose confidential business information, trade secrets, or data protected under federal laws (e.g., Freedom of Information Act exemptions).

Significant Changes to Existing Law

Expands the existing annual FDA performance report under the OTC Monograph Drug User Fee Program (which funds FDA review of OTC drugs via industry fees) by adding specific metrics on order processing, safety activities, and facility compliance—requirements that were not previously mandated.
Introduces a new obligation for public minutes of FDA-industry negotiations, promoting openness in a process that was previously less transparent.
Adds a one-time GAO study on the OTC supply chain, which is not part of current law, to evaluate and potentially recommend improvements in oversight.

Potential Impacts

On Government Agencies: The FDA will face increased administrative burdens for detailed reporting and public disclosures, potentially improving efficiency through better tracking of goals. The GAO report could lead to enhanced inter-agency coordination on supply issues, reducing risks of shortages.
On Citizens: Greater transparency may build public trust in OTC drug safety and availability, as consumers rely on these products (e.g., pain relievers, antiseptics) for everyday health needs without prescriptions. It could indirectly support faster safety responses to issues like adverse events.
On International Relations: Minimal direct impact, though improved U.S. supply chain stability might affect global trade in OTC drugs, as many are imported or exported.

Main Stakeholders Affected

FDA: Primary implementer, required to produce more detailed reports and disclosures.
OTC Drug Industry: Manufacturers, facilities, and contract organizations must comply with expanded registration and fee reporting; negotiations become more publicly accountable, potentially affecting business strategies.
Congress: Receives enhanced FDA reports and the GAO study, enabling better oversight of user fee programs and drug regulation.
Consumers and Public Health Advocates: Benefit from increased access to information on drug safety and supply, though not direct participants.
GAO and Other Federal Agencies: Involved in auditing and coordination for supply chain monitoring.

Notable Legal, Constitutional, or Political Implications

Legal: Reinforces existing user fee frameworks (established under the CARES Act of 2020) without altering core regulatory authority, but emphasizes transparency under laws like the Administrative Procedure Act. Confidentiality clauses protect proprietary data, avoiding conflicts with trade secret protections.
Constitutional: No apparent challenges; the bill aligns with Congress's commerce clause powers to regulate drugs and promote public welfare through informed oversight.
Political: Enhances bipartisan accountability in FDA funding and operations, potentially reducing industry influence perceptions by mandating public negotiation details. The GAO report could spur future legislation if supply vulnerabilities (e.g., to global disruptions) are highlighted, influencing health policy debates.

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

Sponsor

Sen. Kaine, Tim [D-VA]

Recent Actions

2025-07-29: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
2025-07-29: Introduced in Senate

Bill Versions

OTC Monograph Drug User Fee Transparency Act — issued 2025-07-29 — PDF (7 pages)