FDA Aims To “NSURE” Clarity About New Paradigm For OTC Switches
This article was originally published in The Tan Sheet
FDA official Rikin Mehta assures stakeholders that the proposed new paradigm for Rx-to-OTC switches would not create a third class of drugs, give pharmacists prescribing power or eliminate the need for consumers to visit doctors.
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Retailers CVS and Walmart, as well as the National Association of Chain Drug Stores, advocate for a central role for pharmacists in enabling a new class of nonprescription drugs. In comments to FDA, NACDS also supports a switch model that will protect the existing OTC class.
Commissioner Hamburg says FDA asked for input on a “new paradigm” for nonprescription drug approvals in part because pharmaceutical firms have concerns about whether potential access restrictions imposed on an innovating switch would also apply to generic versions that eventually reach the market.
J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.