2013 Year in Review: OPDP Warning Letters and Untitled Letters

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In 2013, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 24 enforcement letters to pharmaceutical manufacturers, four fewer than in 2012. Of the 24 letters, three were Warning Letters and 21 were Untitled Letters. Roughly 67 percent (16 letters) focused on promotional materials directed at healthcare professionals, and 46 percent (11 letters) related to the promotion of drugs with Boxed Warnings, including two Warning Letters. OPDP did not note that any letters involved complaints submitted to the Bad Ad Program, unlike the three letters specified in 2012 and five letters in 2011. OPDP clearly remained invested in the Bad Ad program, however, launching a continuing medical education (“CME”) course in 2013 on how to identify and report violative promotion.

The following were the most cited allegations by OPDP in 2013 along with a comparison to 2012...

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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