Over-the-Counter Monograph Drug User Fee Amendments

This bill renews a program that lets the FDA collect fees from facilities that make over-the-counter (nonprescription) drugs, extending it through 2030. It also changes how the FDA reviews certain nonprescription products applied to the skin, like sunscreens, by allowing the use of real-world evidence and alternatives to animal testing to show these products are safe and effective. The bill requires the FDA to make it clearer how companies can apply to switch a prescription drug to one that can be sold without a prescription, and it sets up a process for identifying drugs that might be good candidates for such a switch. Finally, it directs the Government Accountability Office to study the supply chain for over-the-counter drugs and how the FDA has handled prescription-to-nonprescription switch applications.

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