[email protected] is to be a destination for healthcare provider complaints about drug promotion
In a public announcement on May 11, and accompanied by a ‘Dear Colleague’ letter from FDA Commissioner Margaret Hamburg, FDA’s Div. of Drug Marketing, Advertising and Communications (DDMAC) has unveiled the Bad Ad Program, which “seeks to collaborate with health care professionals to address misleading promotion, wherever it may occur.”
Physicians and others are encouraged to call a toll-free number (877 793 3622), or send an e-mail to [email protected]. An accompanying FAQ explains that “The program seeks to increase the effectiveness of DDMAC's surveillance program, especially with regard to curtailing inappropriate promotional activities of sales representatives visiting the offices of health care professionals and delivering presentations to health care professionals during industry-sponsored dinner and speaker presentations.”
PhRMA’s SVP, Ken Johnson, went public almost immediately, saying, blandly, “We view today’s announcement by FDA as another step to help educate—and receive feedback from—healthcare providers about prescription drug advertising and promotion,” and noting that PhRMA had solicited provider input on its updated DTC guidance to members.
Consumer advocates and industry critics were positive about the announcement, calling it a “clever” and “helpful” way to extend DDMAC’s enforcement mandate. DDMAC says that the reports (which can be anonymous, although the office would prefer hearing directly from a source) will be evaluated by regulatory review officers who will decide whether further action is necessary. DDMAC is rolling out the program in phases, starting with information booths at medical conferences.
The DDMAC action adds to the increasingly fraught environment in which industry attempts to convey information to prescribers and the public. DDMAC has rapped the knuckles of manufacturers’ use of Internet advertising; litigation over off-label promotion has generated huge fines against manufacturers; and states and healthcare systems are increasing the restrictions against contact between pharma reps and prescribers. Whether Bad Ad (which could more properly be called “Bad Rep”) will make any difference depends both on how energetically physicians follow through, and on DDMAC’s enforcement capabilities itself. One could imagine the agency getting inundated with messages that may or may not be substantive; a little known fact alluded to in the Bad Ad communications is that a similar effort, directed at consumers and called EthicAd, has been in place—to little attributable accomplishment—for almost a year. Review officers attempting to track trends could be swayed by a concerted effort to punish selected manufacturers. Meanwhile—as FDA itself notes—promotion by OTC, diet-supplement and med-device manufacturers will continue, mostly unregulated.