Pharmas search for sense in FDA's 14 letters by ProQuest


Drug and device companies are still digesting the FDA Division of Drug Marketing, Advertising and Communications' (DDMAC's) 14 untitled letters issued in March declaring sponsored links on search engines for 45 drugs to be in violation of agency rules. DDMAC is asserting that the information available on the landing page is utterly irrelevant in determining if, in context, the entire 'advertisement' is or is not misleading on account of a failure to disclose risk information. The agency said companies could get right with the law by running unbranded links or treating them as reminder ads, which may tout the name of a drug but not indications, dosage or safety or effectiveness.

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