Will ACNU Proposal’s Dual Rx/OTC Component Simultaneously Help And Hinder Switches?

Proposal is counter to fundamental of FDA platform for approving drugs as either Rx or OTC, with a formulation of a drug with a certain indication available in one class, not both. CHPA says the proposal also runs counter to encouraging pharma firms to invest in research needed for OTC switches.

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Allowing simultaneous Rx and OTC sales of the same drug, a part of a US proposed rule for facilitating OTC switches, could help pharma firms “have the best of both worlds” but also could become a disincentive for investing in preparing applications to move ingredients to nonprescription.

In a separate reference in its recent notice on preparing applications for OTC distribution of naloxone, the Food and Drug Administration suggested the opposite, saying it wouldn’t allow simultaneous Rx...

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