A broad swath of the US drug industry takes the Food and Drug Administration to task for proposing that sponsors of “additional conditions for nonprescription use” applications first demonstrate conventional labeling wouldn’t support an OTC switch before submitting an ACNU proposal.
‘Fail First’ Requirement In ACNU Proposal Prompts Adverse Reactions Across US Drug Industry
PhRMA captures tone of its comments saying “proposed rule might play an important role” in making more drugs available OTC. AAM also references gauntlet, saying proposed pathway “would, in theory, broaden the types of nonprescription drugs available to consumers.” CHPA discusses same concerns as well as additional questions for FDA.
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“I’m not sure exactly if they understood how broad this actually is and what that might potentially lead to or what the follow-up would be if somebody now decides to sell a 10-milligram version of ivermectin for human use,” says food and drug regulation attorney Frederick Stearns.
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“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.
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