Coalition Executive Director John Kamp wrote this OpEd piece published on March 15th by MM&M.
If you or your clients have sent promotion materials to FDA recently for prepublication review, or have been the recipient of a DDMAC Warning Letter, you know that FDA’s DDMAC has assumed a very aggressive enforcement posture.
Senior FDA staff put a fine point on it in late February announcing that the marketing office, known for the past two decades as the Division of Drug Marketing, Advertising and Communication or DDMAC, will soon be elevated to an office, the Office of Prescription Drug Promotion or OPDP. (Pronounce that for me, please.) Making the announcement at the Drug Information Association’s annual marketing conference in New York, Dr. Rachel Behrman, head of the office of medical policy, said the elevation would bring “greater visibility” both inside and outside the FDA.
DDMAC doesn’t need more visibility these days inside marketing departments and their agencies. If 17 Warning Letters by DDMAC in the first month of the year were not enough, listen to this from Tom Abrams, long time head of DDMAC. Citing the increased letters, Abrams used his low-key style to deliver a high key message: It’s time for advertisers, agencies and their trade associations to concentrate on “more self restraint and increased self regulation. Let’s have a race to the top, rather than what some are calling a race to the bottom. It hurts your image and slows down the advisory process.”
For over 20 years the Coalition for Healthcare Communication has called for self-restraint and self-regulation. Nevertheless, some of the examples of violations cited over those two days may be another matter. Abrams was only the first of several FDA presentations that hammered home the same theme, and his warnings were backed up with multiple examples of company advertising – both consumer and professional – that FDA found lacking self-restraint.
Two presentations deserve special notice. In the first, Abrams’ deputy, Kristin Davis, reviewed the “draft guidance” on risk communication released in May of last year. She started by reminding the audience what serious FDA watchers already know, namely that FDA is using the principles of the draft guidance virtually every day in both pre-reviews and Warning Letters. While the Coalition strongly objects to many aspects of the guidance it is clearly the policy of the FDA today and should be required reading for company and agency professionals. (http:1126.96.36.199/pdf/CHC_CommentFDA_Aug2509.pdf),
A second presentation by Marci Kiester, head of a DTC ad review team, called out ads for five drugs that appeared in virtually every consumer medium, including what staffers called a new version of “Tupperware parties.” The litany of failures was all too familiar: overstatement of efficacy, omission and minimization of risks, broadening of indication, testimonials that went beyond clinical evidence, unsubstantiated claims, promotion of an unapproved drug, as well and “false and misleading” statements.
Call it what you wish, DDMAC or OPDP. But start by reading the risk guidance and reviewing the recent Warning Letters. Most importantly, be prepared for even stricter marketing enforcement from the FDA.
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