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.
