OTC Labeling Adopted By FDA In Forced Switch Would Violate Regs Comments Say
This article was originally published in The Tan Sheet
FDA could not adopt a drug's approved OTC label from another country as acceptable U.S. OTC labeling without violating its own regulations, according to the American Association of Physicians & Surgeons and Competitive Enterprise Institute
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A drug sponsor may create and use alternative labeling saying it requires prescription distribution for a medicine even if FDA has determined the drug does not need to be limited to the Rx arena, according to attorney Andrew Krulwich of the Washington, D.C.-based law firm Wiley, Rein & Fielding
FDA may rely on a drug's foreign OTC marketing experience to determine whether an Rx product should be switched OTC in the U.S. without sponsor consent, Commissioner Mark McClellan, MD/PhD, said at a Manhattan Institute roundtable discussion for buyside analysts May 16
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