If you or your clients have sent promotion materials to FDA recently for pre-publication review, or—God forbid—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 unit, known for the past two decades as the Division of Drug Marketing, Advertising and Communication or DDMAC, will soon be elevated to the Office of Prescription Drug Promotion or OPDP. 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. If 12 Warning Letters by DDMAC in the first month of the year were not enough, listen to DDMAC head Tom Abrams, who cited the increase in enforcement letters and used his low-key style to deliver a high-key message, calling on advertisers, agencies and their trade associations to exhibit “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.”   

At the same event, Abrams’ deputy Kristin Davis reviewed the draft guidance on risk communication released in May of last year. While the Coalition strongly objects to many aspects of the guidance, it should be required reading for company and agency professionals.

Call it what you wish, DDMAC or OPDP, but be prepared for even stricter marketing enforcement from the FDA.

John Kamp is executive director of the Coalition for Healthcare Communications