DDMAC enforcement letters up 26% in 2010

Share this article:
Regulators rapped Sepracor’s “boxing bed” ad for making misleading claims about efficacy and MOA
Regulators rapped Sepracor’s “boxing bed” ad for making misleading claims about efficacy and MOA
If it feels like the FDA sent out more letters this year scolding pharmas for their advertising and promotion practices, it's because the agency did.

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.
Share this article:

Email Newsletters

More in News

House bill would speed approval once EU OKs same product

House bill would speed approval once EU OKs ...

The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union

Rep access continues to shrink

Rep access continues to shrink

Sales reps are experiencing even more limited physician access, according to a report by Chicago consultancy ZS Associates.

Allergan touts reorg, plans to lay off 13% of workforce

Allergan touts reorg, plans to lay off 13% ...

Allergan's second-quarter earnings, and a new round of cuts, are now part of the Botox maker's record as it seeks to remain independent.