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"Recognize and report" is the message of the agency's Bad Ad Program, an educational outreach effort by the Division of Drug Marketing, Advertising and Communications (DDMAC) that will “help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” according to DDMAC director Tom Abrams.
The program will be rolled out in three phases, said FDA. In Phase 1, DDMAC will engage healthcare providers and distribute educational materials at select medical conventions and through partnerships with medical societies. Phases 2 and 3 “will expand the FDA's collaborative efforts and update the educational materials developed for Phase 1,” said FDA.
The program represents an effort to expand the agency's monitoring capability by enlisting the targets of promotion to serve as FDA's eyes and ears on the street. Traditionally, the agency noted, monitoring efforts have relied on reviews of promotional pieces submitted by drug companies, industry complaints and field surveillance at big medical conventions.“Although these efforts are effective, the agency has limited ability to monitor promotional activities that occur in private,” said FDA.
Reports can be submitted anonymously, though the agency will encourage callers to leave contact info for follow-ups, the agency said. The website for the program is at: www.fda.gov/badad.