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 continued funding for the FDA's OTC drug review process. The changes include adjustments to fee assessment periods, revenue amounts, and reporting requirements.
Expected Effects
The bill will ensure the FDA has continued funding to review and regulate OTC monograph drugs. This will likely lead to more efficient review processes and potentially faster access to new or modified OTC drugs for consumers. The bill also includes provisions for workload adjustments and technical corrections to existing regulations.
Potential Benefits
- Ensures continued funding for FDA review of OTC monograph drugs.
- May lead to faster access to new or modified OTC drugs.
- Provides for adjustments to fees based on workload and inflation.
- Includes technical corrections to improve regulatory clarity.
- Supports the development of voluntary consensus standards for pharmaceutical quality.
Most Benefited Areas:
Potential Disadvantages
- Increased fees for manufacturers could potentially increase the cost of OTC drugs for consumers.
- The one-time workload adjustment could create uncertainty in fee amounts for manufacturers.
- Some adjustments may disproportionately affect smaller manufacturers.
- The complexity of the fee structure may lead to administrative challenges.
- Potential for delays in implementation due to the effective date being tied to appropriations acts.
Constitutional Alignment
The bill aligns with the Commerce Clause (Article I, Section 8, Clause 3) of the U.S. Constitution, which grants Congress the power to regulate interstate commerce, including the regulation of drugs. The user fees are intended to support the FDA's regulatory activities, which fall under this power. The bill does not appear to infringe upon any individual rights or liberties protected by the Constitution or its amendments.
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).