2012 Year in Review: FDA OPDP Warning Letters and Untitled Letters


In 2012, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 28 enforcement letters to pharmaceutical manufacturers, two fewer than in 2011. Of the 28 letters, three were Warning Letters and 25 were Untitled Letters. Roughly 68 percent (19 letters) of the promotional materials reviewed in the enforcement letters were directed at healthcare professionals, and 5 of OPDP’s enforcement letters were issued regarding drugs with boxed warnings, including one Warning Letter. Only three enforcement letters (11% of all enforcement letters issued) were the result of complaints received through the Bad Ad Program, one of which was a Warning Letter and two of which cited oral statements by sales representatives. Two enforcement letters were issued regarding emerging media —an iPad sales aid and a podcast interview.

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