Over-the-Counter Monograph Drug User Fee Amendments
Summary
H.R. 4273, the "Over-the-Counter Monograph Drug User Fee Amendments," aims to revise and extend the user fee program for over-the-counter (OTC) monograph drugs. The bill amends the Federal Food, Drug, and Cosmetic Act to ensure dedicated funding for OTC monograph drug activities. This is achieved through user fees paid by facilities that manufacture these drugs.
The bill outlines specific adjustments to fee structures, revenue amounts, and due dates for fiscal years 2026 through 2030. It also includes provisions for inflation adjustments, operating reserve adjustments, and potential one-time workload adjustments. The legislation sets sunset dates for the authorization and reporting requirements related to these fees.
Ultimately, the bill seeks to provide a stable and predictable funding mechanism for the FDA's oversight of OTC monograph drugs, ensuring continued safety and efficacy of these products.
Expected Effects
The passage of H.R. 4273 will extend the user fee program for OTC monograph drugs, providing the FDA with a dedicated funding stream for their regulation. This will likely lead to more consistent and thorough oversight of these drugs.
Manufacturers of OTC monograph drugs will be subject to revised fee structures and payment schedules. This could impact their operational costs and potentially influence the availability or pricing of certain OTC products.
The amendments aim to improve the efficiency and predictability of the FDA's OTC drug review process, potentially leading to faster approvals of new or modified OTC products.
Potential Benefits
- Ensured Funding for Drug Oversight: Guarantees continued funding for the FDA's oversight of OTC monograph drugs, helping to ensure their safety and efficacy.
- Improved Review Process: Aims to streamline and improve the efficiency of the FDA's review process for OTC drugs, potentially leading to faster approvals.
- Public Health Protection: By ensuring adequate resources for OTC drug regulation, the bill contributes to protecting public health.
- Clarity and Predictability: Provides clarity and predictability regarding fee structures and payment schedules for manufacturers.
- Adaptability: Includes provisions for adjustments to fees based on inflation and workload, allowing the program to adapt to changing needs.
Most Benefited Areas:
Potential Disadvantages
- Increased Costs for Manufacturers: The user fees may increase operational costs for manufacturers of OTC monograph drugs.
- Potential Impact on Drug Availability/Pricing: Increased costs for manufacturers could potentially lead to higher prices for consumers or reduced availability of certain OTC drugs.
- Administrative Burden: The revised fee structures and payment schedules may create additional administrative burden for both the FDA and manufacturers.
- Potential for Inequitable Impact: Smaller manufacturers may be disproportionately affected by the user fees compared to larger companies.
- Workload Adjustment Uncertainty: The one-time facility fee workload adjustment introduces some uncertainty into the fee structure.
Constitutional Alignment
H.R. 4273 appears to align with the US Constitution, particularly the Commerce Clause (Article I, Section 8), which grants Congress the power to regulate interstate commerce. The regulation of over-the-counter drugs falls under this power, as these drugs are often manufactured and sold across state lines.
The bill also aligns with the general welfare clause (Preamble), as it aims to ensure the safety and efficacy of OTC drugs, thereby promoting public health. The user fee structure is a mechanism to fund this regulatory activity.
There are no apparent violations of individual rights or liberties guaranteed by the Bill of Rights. The fees are imposed on manufacturers, not directly on individuals, and do not infringe on any protected freedoms.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).