In addition to sending out more warning letters and stepping up enforcement activity, the Food and Drug Administration wants health professionals to do more to police drug marketing and advertising. The agency’s “Bad Ad” program urges doctors and other health professionals to report any false or misleading ads or inappropriate marketing pitches. Depending on one’s point of view, the program is either an efficient way to extend FDA’s oversight capabilities, or just one more attempt by over-zealous regulators to stifle free speech.
The stated aim is to assist FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) in its efforts to deter promotional activities. DDMAC examines promotional pieces submitted to the agency, scans ads and TV commercials informally, and monitors drug company exhibits and programs at medical meetings. An important source of information is all the complaints the division receives are from industry competitors who see another company getting away with off-label promotion or unfair comparisons. It’s impossible for DDMAC to catch everything, and certainly not what’s said in meetings between doctors and sales reps or at sponsored dinner programs.
To kick off the Bad Ad program, which was announced last month, DDMAC staffers will give talks and distribute educational materials to providers at medical conventions and society meetings. A brochure advises doctors on how to recognize misleading promos: omitting risks, overstating effectiveness, promoting off-label uses, or making misleading comparative claims. FDA is making it easy for doctors to squeal about objectionable messages by establishing a special call-in number and email address.
It’s not yet clear if the campaign will generate a lot of finger-pointing—or if it does, how DDMAC will deal reports that are vague and undocumented (anonymous calls are okay). Marketers fear that doctors will file complaints based on misunderstandings and personal prejudices. Supporters of the program anticipate that marketers and sales reps will modify their pitches if they think that their audience is taking a much closer look at what they say. But free-speech advocates like the Washington Legal Foundation fear it will chill open exchange of health information, which can be useful.
The Bad Ad campaign fits FDA’s effort to step up enforcement, as Commissioner Margaret Hamburg promised a year ago. The agency has issued 186 warning letters so far this year, putting it on track to meet last year’s record of 570 enforcement missives, according to BNet Pharma. And more of those are coming from DDMAC, which doubled its warning-letter rate to 41 in 2009, vs. 21 the year before. Many recent letters challenge Internet marketing, an activity that remains on FDA’s radar screen. In April, DDMAC sent a long warning letter to Novartis challenging the company’s use of Web sites to promote unapproved uses and to make unsubstantiated claims for Gleevec. FDA plans to develop guidelines on Internet promotion and use of social media by drug marketers, but it’s proving to be a complicated business.