FDA urging doctors to report bad ads
May 11, 2010 – 12:59 pm by ChrisDDMAC’s workload is about to get a lot steeper.
Mark Senak of Eye on FDA broke the news on Twitter that FDA has launched a new program, the “Truthful Drug Advertising and Promotion Ad Program,” or the “Bad Ad Program.” Ed Silverman, AKA Pharmalot, also reports on it here.
“The Bad Ad Program will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” says Thomas Abrams, director of DDMAC, in a statement.
The program will be rolled out in three phases. In Phase 1, DDMAC will engage health care providers at specifically selected medical conventions and partner with specific medical societies to distribute educational
materials. Phases 2 and 3 will expand the FDA’s collaborative efforts and update the educational materials developed for Phase 1.
Health care professionals are encouraged to report a potential violation in drug promotion by sending an email to badad@fda.gov or calling 877-RX-DDMAC. Reports can be submitted anonymously; however, the FDA encourages providers to include contact information so that DDMAC officials can follow up.
Doctors are being encouraged to report promotional violations to FDA – omission of risk information, promotion of unapproved use, and overstatements of effectiveness. The examples offered by FDA show violations that could occur at speaker programs, medical conferences, and in-office interactions with sales representatives.
DDMAC traditionally has monitored promotional materials and conventions for violations, and conducted investigations based on industry complaints, but this seems to mark the first time the agency will really be able to get a sense of what’s actually happening in the physicians’ office and speakers events. “… the agency has limited ability to monitor promotional activities that occur in private,” FDA officials say.
One can almost hear the frantic scrambling occurring in the offices of every field force manager at every company, in every marketing department, etc. The sense of consternation must be epic.
Reuters reports that the program was created from the input and assistance of two former pharma pitchmen who joined the agency:
“After joining the agency as ad watchdogs, the pair realized ‘we don’t really have a presence out in the field where we used to work,’ said Bob Dean, one of the FDA employees who helped create the program.”
Rich Meyer at World of DTC Marketing asks, “How can an agency be more clueless?”
“Like physicians don’t have enough to do right now,” Mr. Meyer says. “This tells me that DDMAC/FDA is in deep trouble monitoring drug industry marketing and rather than ramp up reviewers they are asking for outside help.”
