S. 2513: OTC Monograph Drug User Fee Transparency Act

This bill, known as the OTC Monograph Drug User Fee Transparency Act, aims to enhance the transparency and reporting related to the regulation of over-the-counter (OTC) monograph drugs. Here’s a summary of the key provisions of the bill:

1. OTC Monograph Drug Performance Reports

The bill proposes amendments to the Federal Food, Drug, and Cosmetic Act regarding the annual performance reports submitted by the Food and Drug Administration (FDA). Starting fiscal year 2026, these reports will include:

• Details on the progress of the FDA in meeting regulatory goals for Tier 1 and Tier 2 OTC monograph order requests.
• Statistics on how many proposed orders were issued versus final orders issued in the previous fiscal year for safety and effectiveness of OTC monograph drugs.
• Data on the average timeline for processing these requests.
• Information about post-market safety activities, including how safety information is collected and the effectiveness of the systems in place.
• Details about the registration of OTC monograph drug facilities and the payment of any associated fees.

2. Public Availability of Negotiation Minutes

The bill mandates that the FDA provide publicly available written minutes from meetings where negotiations take place between the FDA and firms in the regulated industry. These minutes must detail:

• Any significant proposals from either side during the negotiations.
• Controversies that arose, including how they were resolved.

3. GAO Report on Supply Chain Assessment

Within two years after the bill’s enactment, the Comptroller General of the United States is required to submit a report that assesses the supply chain for OTC monograph drugs. This report will focus on:

• The stability and effectiveness of the supply chain.
• The information collected by the FDA relating to this supply chain.
• How the FDA uses this information for regulatory decisions.
• Coordination with other federal agencies to monitor and address any disruptions in supply.
• Identifying what further information or authority might be necessary to maintain supply chain stability.

4. Confidentiality Provisions

The legislation includes privacy provisions to ensure that sensitive information is not disclosed in the reports, thus protecting proprietary information and privacy as outlined in existing laws.

Relevant Companies

• PG - Procter & Gamble: They could be impacted as they manufacture various OTC drugs and will need to comply with new reporting requirements and any potential changes in FDA oversight.
• CLX - The Clorox Company: As another manufacturer of OTC health products, they may face changes in operational procedures or reporting mandates under the new law.
• UNH - UnitedHealth Group: The bill may influence policy adjustments related to OTC drug offerings, impacting insurers that cover OTC medications.