Switch Paradigm Change Sees Long Road, Breeds Questions
This article was originally published in The Pink Sheet Daily
Industry has opposed establishing an intermediate class of drugs between Rx and OTC, and FDA has held it does not have authority to require firms to allow products to be approved for behind-the-counter access or some other alternative distribution. But the creation of some form of third route to access appears likely.
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The questions FDA poses for a March 22-23 hearing indicate the agency is delving into greater detail than in its previous discussions of alternative routes to access pharmaceutical treatments. FDA says decisions would be made case by case, but refers to treating conditions including high cholesterol, high blood pressure, migraines and asthma.
FDA says OTC drug oversight remains important even as the Office of Nonprescription Products loses star billing within the Office of New Drugs, but the change could challenge firms to convince the agency to prioritize regulation of their products