2011 Year in Review: OPDP Warning Letters and Untitled Letters

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In 2011, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP), formerly known as the Division of Drug Marketing, Advertising, and Communications (DDMAC), issued a total of 30 enforcement letters to pharmaceutical manufacturers, 22 less than in 2010. Of the 30 letters, 5 were Warning Letters and 25 were Untitled Letters. Roughly two-thirds (67%) of the promotional materials reviewed in the enforcement letters were directed at healthcare professionals, and one-third of OPDP’s enforcement letters were issued regarding drugs with boxed warnings, including two Warning Letters. Five enforcement letters (17% of all enforcement letters issued) were the result of complaints received through the Bad Ad Program, two of which were Warning Letters.

Elevation of DDMAC to OPDP

On September 19, 2011, DDMAC was converted from a division to an office within CDER’s Office of Medical Policy and became known as OPDP. With this change came a realignment of DDMAC’s staff into two groups focused on reviewing different types of promotion: the Division of Professional Promotion and the Division of Direct-to-Consumer Promotion. As a result of the change, OPDP has increased its review staff and enforcement capacity.

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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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