In 2010, the CDER Division of Drug Marketing, Advertising, and Communications (DDMAC) issued a total of 52 enforcement letters to pharmaceutical and biologics manufacturers, 14 more than in 2009. Of the 52 letters issued by DDMAC, 13 were Warning Letters and 39 were Untitled Letters. Eighteen of DDMAC’s enforcement letters were issued regarding drugs with boxed warnings, including three Warning letters (23% of all warning letters) and 15 Untitled letters (38% of all untitled letters). The Advertising and Promotional Labeling Branch of CBER (APLB) issued only six enforcement letters in 2010, the same number as in the two previous years. Of the six letters issued by APLB, one was a Warning Letter and five were Untitled Letters.
Notable Trends in 2010:
A number of trends emerged in 2010:
- Internet-related promotional media continue to be a significant area of focus, with thirteen letters issued for claims made in emails, websites, website videos, social media, and/or webcasts.
- Videos, whether on websites or in other promotional contexts, were a focus of FDA enforcement efforts. Eight Warning Letters scrutinized the content and format of promotional videos.
- One (and only so far) Untitled Letter focused on shared media generated by a Facebook widget, signaling the start of enforcement efforts in the area of social media.
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