Remember the episode of The Andy Griffith Show in which Gomer Pyle runs after Barney Fife screaming “citizen’s arrest, citizen’s arrest” after Barney makes a U-turn on Main Street? Perhaps that is what came to mind when you read the press release issued by FDA announcing a new outreach program enlisting health care professionals in FDA’s efforts to prevent misleading promotion of prescription drugs.
This outreach effort will be administered by the Agency’s Division of Drug Marketing, Advertising and Communications (DDMAC) and is called the Bad Ad Program. Dr. Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, issued a letter to health care professionals stating that the purpose of the program is twofold: “first, to let you know about important steps FDA is taking to prevent misleading or inaccurate promotion of prescription drugs by drug companies; and second, to request your help identifying and reporting these activities.”
Information posted on the Bad Ad Program page of the FDA Web site indicates that the goal of the program is “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.”
FDA states that 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.
Dr. Hamburg’s letter indicates that DDMAC will kick off the Bad Ad Program by exhibiting at some of the major medical conferences starting in May 2010. Reviewers will be speaking with health care professionals at the conferences and educating them about how to recognize misleading prescription drug promotion.
While the program is focused primarily on health care professionals, anyone can submit a complaint to FDA. Potential violations can be reported by e-mail to firstname.lastname@example.org or by calling 877-RX-DDMAC. While reports may be made anonymously, FDA encourages providers to include contact information so that DDMAC can follow up if necessary.
FDA invites health care providers to call DDMAC at 301-796-1200 if they are unsure about what constitutes misleading promotion, or if they want to discuss the Bad Ad Program features in greater detail.
Certainly, if Barney Fife came upon misleading drug promotion he’d want to “nip it in the bud!” It will be interesting to see, however, if health care professionals feel empowered, inclined or, frankly, have the time, to respond to this call for assistance from the FDA.
More information about the Bad Ad Program — including examples of misleading promotion, frequently asked questions, key points about the program and a copy of Dr. Hamburg’s “Dear Colleague Letter” — can be found on the FDA Bad Ad Web site or by clicking here.