Makary’s push to approve more OTC drugs could test FDA’s new regulatory tools

By Ned Pagliarulo and Amanda Conti

FDA Commissioner Martin Makary has signaled a renewed push to make more drugs available without a prescription, raising questions about how the agency could use its recently expanded regulatory toolkit to support broader nonprescription access.

Recent changes to the FDA’s nonprescription drug framework — including reforms under the CARES Act, reauthorization of OMUFA, and the introduction of the “additional condition for nonprescription use” (ACNU) pathway — may give both the agency and sponsors new flexibility to pursue OTC approvals.

This AgencyIQ analysis examines what a large-scale shift toward nonprescription drugs could look like in practice, how FDA leadership is framing the opportunity, and where regulatory and evidentiary challenges may emerge.

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