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Healthy Skepticism Library item: 19246

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: news

Arnold M
DDMAC enforcement letters up 26% in 2010
Medical Marketing & Media 2010 Dec 28

Full text:

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.


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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909