Second Wind For OTC Monograph User Fee Legislation In House Hearing
This article was originally published in The Rose Sheet
House Health Subcommittee's “Modernizing FDA’s Regulation of Over-the-Counter Drugs” hearing Sept. 13 will "examine draft legislation to establish" a user fee program to support FDA's work on evaluating proposals for additions or changes to its nonprescription drug monographs.
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Products marketed for cosmetic use but formulated with drugs are regulated as topical drugs and would be subject to potential OTC user fees, although the products have little similarity with oral or nasal delivery nonprescription drugs also available under FDA's monograph system, consultant David Steinberg says.
FDA officials emphasize that without legislation from Congress, the OTC monograph program is not changing, and without a user fee program, the agency couldn’t implement changes.
FDA’s Aug. 23 webinar will update industry stakeholders on progress to modernize its OTC monograph program, but without user fee legislation, new performance goals will not take effect; stakeholders hold out hope a standalone OTC user fee bill could still progress in Congress.