This bill creates a new expedited approval process for over-the-counter medications by allowing the FDA to designate certain nonprescription drugs as "priority" and streamline their review. To qualify, drugs must be new molecules, address novel nonprescription uses with meaningful public health benefits, or contain active ingredients never before available without a prescription, though drugs requiring risk management strategies or controlled substances are excluded. The FDA has 60 days to decide whether to grant priority status and must take supportive actions like holding development meetings, providing guidance, assigning dedicated review staff, and allowing reliance on real-world evidence to speed the approval process. The bill requires the FDA to publish a list of medical conditions for which over-the-counter drugs could provide significant public health value within 18 months and submit a report to Congress within four years documenting how many drugs received priority designation and were ultimately approved. The new authority expires on September 30, 2032, and the bill clarifies that expedited review does not lower the safety and effectiveness standards drugs must meet for approval.
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