A substantive expansion and several technical adjustments. v2 introduces a new section focused on the regulation of certain nonprescription drugs, expanding who can receive FDA development advice. It also includes minor clarifications to definitions and reallocates direct cost adjustments for future fiscal years.
Over-the-Counter Monograph Drug User Fee Amendments
- Sponsor
- Rep. Latta, Robert E. [R-OH-5]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Sep 17, 2025
Bottom line
The bill extends the FDA's authority to collect user fees from OTC drug manufacturers to fund regulatory activities, with updated fee structures and expanded scope for stakeholder engagement.
What it actually does
This bill reauthorizes and amends the Over-the-Counter (OTC) Monograph Drug User Fee program under the Federal Food, Drug, and Cosmetic Act for fiscal years 2026 through 2030. It revises how facility fees are assessed, adjusts revenue targets and inflation calculations, and introduces a new one-time workload adjustment for facilities. Additionally, it expands the definition of OTC monograph drug activities to include certain testing procedure modifications based on voluntary consensus standards and allows broader representation in development advice discussions with the FDA.
Proponents argue
Proponents argue that reauthorizing these user fees is crucial for the efficient and effective regulation of over-the-counter drugs, ensuring public safety and timely access to new and improved products. They contend that the updated fee structure and adjustments will provide stable and predictable funding for the FDA's OTC monograph program, allowing for necessary scientific and regulatory advancements, including the incorporation of modern testing standards.
Opponents contend
Potential opponents might argue that increasing or adjusting user fees could place an undue financial burden on smaller OTC drug manufacturers, potentially limiting innovation or increasing costs for consumers. Concerns could also be raised about the FDA's accountability in utilizing these funds, or whether the expanded scope of activities truly benefits public health proportionally to the fees collected.
The bill is relatively concise and its core provisions are clearly laid out, making it accessible for an informed reader to understand its implications within a reasonable timeframe.
Sections 4(b), 5, 7
Extension of OTC Monograph Drug User Fee Program
This provision extends the FDA's authority to collect user fees from over-the-counter (OTC) drug manufacturers and facilities from fiscal year 2026 through 2030. It ensures continued funding for the FDA's regulatory activities related to OTC monograph drugs, which include reviewing and updating monographs that define the safety and effectiveness of nonprescription drug ingredients.
Supporters argue
Supporters contend that this extension is vital for maintaining the FDA's capacity to regulate the vast market of OTC drugs, ensuring their safety and efficacy for consumers. Without reauthorization, the program's funding would lapse, potentially jeopardizing public health.
Critics contend
While direct opposition to reauthorization is rare, some might argue for greater scrutiny on how the FDA utilizes these funds or advocate for alternative funding mechanisms to reduce industry burden.
Tradeoffs
The primary tension is balancing the need for robust regulatory oversight with the financial burden placed on the industry.
Section 4(a)
Changes to Facility Fee Assessment and Due Dates
This section modifies the "applicable period" for determining which facilities owe fees and updates the criteria for exemption for facilities that have ceased operations. Crucially, it revises the due dates for facility fees, introducing a two-installment payment schedule for fiscal year 2027 (October 1, 2026, and February 1, 2027) and setting single due dates for other fiscal years.
Section 4(c)(4)
Introduction of Workload-Based Fee Adjustment
This new provision allows the Secretary of Health and Human Services (FDA) to implement a one-time increase in facility fees for fiscal years 2028, 2029, or 2030. This adjustment can only occur if the average number of OTC monograph drug facilities over the preceding three fiscal years exceeds 1,625, and if the average percentage of facilities on arrears lists is less than 30%. The adjustment amount is tied to this "excess facility percentage."
Section 3
Inclusion of Voluntary Consensus Standards for Testing Procedures
The bill amends the definition of "OTC monograph drug activity" to include the addition or modification of testing procedures for OTC monograph drugs, provided these procedures reflect a voluntary consensus standard recognized by the Secretary of Health and Human Services. This means that activities related to incorporating industry-developed, recognized quality standards into OTC drug testing can now be supported by user fees.
Section 6(a)
Broader Representation for Development Advice
This amendment allows "organizations nominated by sponsors or requestors to represent their interests in a proceeding" to receive development advice from the FDA regarding nonprescription drugs marketed without an approved drug application. Previously, only sponsors or requestors themselves could receive such advice. This broadens the scope of who can engage with the FDA on behalf of industry interests.
Allows the Secretary to implement a one-time increase in facility fees for FY2028, 2029, or 2030 if the average number of facilities exceeds 1,625 over the preceding three fiscal years and the average percentage of facilities on arrears lists is less than 30%. The adjustment amount is based on the "excess facility percentage."
Section 4(c)(4)
Why it matters:This is standard legislative practice for highly technical, conditional financial mechanisms. It requires specific triggers and calculations, making it unsuitable for a high-level summary.
Case for: Supporters argue it provides a necessary, flexible mechanism for the FDA to respond to significant, sustained increases in the number of regulated facilities, ensuring adequate resources without requiring immediate legislative intervention. It also subtly incentivizes timely fee payments by linking the adjustment to arrears rates.
Case against: Critics might argue that such a conditional, formulaic adjustment introduces unpredictability for industry budgeting, making it harder for companies to forecast their regulatory costs years in advance. The specific thresholds might also be debated as arbitrary.
Estimated impact: Could lead to a significant, one-time increase in total facility fee revenue (and thus individual facility fees) if triggered, potentially millions of dollars depending on the "excess facility percentage."
Amends Section 505G(h) of the FD&C Act to allow "organizations nominated by sponsors or requestors to represent their interests in a proceeding" to receive development advice from the FDA.
Section 6(a)
Why it matters:This is likely standard legislative practice for technical amendments that refine existing processes. It's not inherently evasive but rather a detail that might not warrant prominent placement in a bill focused on user fees.
Case for: Proponents argue this improves communication efficiency and allows for more consolidated, impactful engagement between the FDA and the OTC industry, benefiting both regulators and regulated entities by leveraging collective expertise.
Case against: No strong case against, but some might express minor concerns about the potential for increased lobbying influence if not managed transparently, or if it inadvertently sidelines smaller individual companies.
Estimated impact: Improves communication channels and potentially streamlines regulatory discussions, leading to more efficient development of OTC drugs. No direct financial impact.