DDMAC enforcement letters up 26% in 2010
Regulators rapped Sepracor’s “boxing bed” ad for making misleading claims about efficacy and MOA
The FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) has written 26% more enforcement letters to drug companies over promotional practices this year than it did in 2009.
DDMAC has posted 52 letters so far this year, compared to 41 in 2009, and the agency wouldn't rule out posting more before year's end. Of those 52, 39 were untitled letters and 13 were the more serious warning letters. In 2009, DDMAC issued 28 untitled letters and 13 warning letters.
Half of all letters concerned promotion directed toward healthcare professionals, while 38% targeted consumer promotion and the remainder addressed promotion that could be reach both consumers and professionals, mostly websites. Fifteen letters concerned digital promotion, from websites to consumer-directed online video and an adherence email blast. Six cited violative sales aids, four were for journal ads, two were on TV ads (for Lunesta, pictured, and Aricept) and another two consumer print ads.
Two letters concerned oral statements made at conferences – one by an Amgen rep, one by a physician on behalf of Adolor's Entereg – and another concerned a Florida dermatologist who talked up Ipsen's Dysport on TV and in magazines before it was approved. Just one – a warning letter on Hill Dermaceuticals' DermaSmoothe/FS website – resulted from the agency's vaunted Bad Ad program.
The Center for Biologics Evaluation and Research issued six enforcement letters concerning promotion of biologics in 2010, including one warning letter and five untitled letters. That's about on par with 2009's seven letters – one warning letter and six untitled letters.