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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The American Society of Anesthesiologists and attorney Scott Lassman disagree with the FDA's suggestion that studies showing all naloxone products can be used safely over the counter indicates all of them can be moved to nonprescription status. Both were included in comments submitted ahead of the agency's Nonprescription Drug and Anesthetic and Analgesic Drug Products advisory committee meeting on the subject.
American Society of Anesthesiologists and attorney Scott Lassman say in comments submitted to docket for meeting of FDA’s Nonprescription Drug and Anesthetic and Analgesic Drug Products they disagree with agency’s suggestion studies showing all naloxone products in all delivery formats can be used safely OTC point to all the products moving to nonprescription.
“Right now, it looks like [FDA’s] hands are tied because that's their message … But they're holding both ends of the rope. Come on, get that knot undone,” says AHPA president Michael McGuffin. “To anybody who's looking at this as an outsider, you would say, ‘What is the agency doing?’’ says NPA CEO Daniel Fabricant.