Over-the-Counter Monograph Drug User Fee Amendments
Summary
The Over-the-Counter Monograph Drug User Fee Amendments aim to revise and extend the user fee program for over-the-counter (OTC) monograph drugs. This bill amends the Federal Food, Drug, and Cosmetic Act, focusing on the fees assessed to facilities that manufacture OTC monograph drugs and OTC Monograph order requests. The goal is to ensure adequate resources for the FDA to regulate and oversee these drugs effectively.
Expected Effects
The bill will change the timing and amounts of fees paid by OTC drug manufacturers. It also introduces adjustments to fee calculations based on inflation, operating reserves, and workload. Additionally, the bill addresses the process for Rx-to-nonprescription switches, aiming to increase clarity and predictability.
Potential Benefits
- Ensures continued funding for the FDA's oversight of OTC monograph drugs.
- Provides greater clarity and predictability in the Rx-to-nonprescription switch process, potentially increasing consumer access to medications.
- Encourages the use of real-world evidence and non-animal testing methods for topical drug approvals.
- Enhances postmarket safety activities related to OTC monograph drugs.
- Improves the stability and monitoring of the OTC monograph drug supply chain.
Potential Disadvantages
- Increased costs for OTC drug manufacturers, which may be passed on to consumers.
- Potential for delays in the implementation of new testing procedures.
- The one-time facility fee workload adjustment could create uncertainty in budgeting for manufacturers.
- Some adjustments to fee calculations are complex and may be difficult for manufacturers to understand.
- The bill does not address the underlying issues that may be causing supply chain instability.
Constitutional Alignment
This bill appears to align with the US Constitution, particularly Article I, Section 8, which grants Congress the power to regulate commerce. The regulation of OTC drugs falls under this power. The bill also does not appear to infringe upon any individual rights or liberties protected by the Bill of Rights.
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).