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.
You may also be interested in...
“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.
OTC drug and dietary supplement industry trade group executives discuss questions on potential market and regulatory developments affecting their members’ businesses. HBW Insight reports on OTC drug sector’s outlook for the FDA potentially publishing a final rule to expand switch opportunities as well as its anticipation of marketplace results from monograph program overhaul.
FDA’s “Additional Condition for Nonprescription Use” proposal is all about information which won’t be printed on DFLs but will be integral to whether some switch proposals’ approval. But agency doesn’t explicitly exclude switch sponsors from assigning delivery of ACNU information to staff in stores or in online chats.