The FDA launched a new program Tuesday to educate healthcare providers about their role in ensuring that prescription drug advertising and promotion is truthful and not misleading. And the agency gave the outreach effort an apt name: The Bad Ad Program.
FDA staff routinely check ads on television or in magazines or medical journals, Reuters notes, but it is hard to track closed-door pitches to healthcare providers. But this effort is intended to combat this problem.
According to an FDA statement, the Bad Ad Program will be rolled out in three phases. Starting this month, CDER's Division of Drug Marketing, Advertising and Communications will engage healthcare 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 the first phase. Healthcare providers will be encouraged to report any false or misleading advertising to the FDA and may do so anonymously.
The plan for the program came from two former drug company pitchmen who joined the agency as ad watchdogs, according to Reuters. Mike Sauers, who conceived of the idea with Bob Dean, said the goal is to teach doctors "how to be better consumers of information they receive from the drug reps"--a skill they don't typically learn in medical school.
The effort comes as the FDA has been getting tougher on drug promotions, as Thomas Abrams, who heads up DDMAC, asserted earlier this year. His group sent 41 enforcement letters in 2009, up from just 21 the year before. This past January alone, the division sent out another nine and has plans to continue that pace through 2010. Indeed, the agency has recently sent letters to a number of drugmakers--including Roche, Sanofi-Aventis and Adolor--warning about misleading promotions.
- check out the FDA's announcement about the program
- read the key points about the Bad Ad Program
- see the Reuters coverage