June 14th, 2011
The FDA: Our Bad Ad Program Is Working
One year after launching its Bad Ad program - an effort to encourage healthcare professionals, in particular, to alert the FDA to report misleading prescription drug promotions - the agency has released its first annual report and maintains the effort is having the desired effect.
To wit, of 328 reports of “potentially untruthful or misleading promotion,” 188 were submitted by healthcare professionals, 116 were submitted by consumers and 24 were submitted by people at drugmakers. In the past, the FDA says an average of about 104 reports were received each year. As a result, “this number and diversity of reports received after the Bad Ad program was launched indicates to FDA that the program was successful in raising awareness of untruthful and misleading promotion.”
And of 188 reports submitted by healthcare professionals, 87 were resulted in a comprehensive review, which the FDA argues demonstrates “a relatively strong level of knowledge in the medical community about what constitutes misleading promotion.” Of 116 reports submitted by consumers, 24 generated the same kind of review, while 14 of the 24 reports identified by industry yielded a review. Only 4 percent of reports were anonymous, by the way (read more here).
“I think the news here isn’t so much about what FDA has heard from doctors or about how many letters FDA has sent, but about the in terrorem impact of the Bad Ad program. Just another reason for companies to monitor their promotional behavior, Arnie Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer, tells us. “Hey, companies, you never know whether the doctor is or is not an informant for FDA so be careful what you say, even in the confines of the doctor’s office…The FDA is deputizing doctors to become informants. It’s like the old ‘Deputy Dawg’ show, except it’s ‘Deputy Doc.’ ”
Consequently, the FDA vows to expand the program and will continuing education on the Internet, and also develop educational efforts to focus on students and those in the early stages of their careers in healthcare. This will include collaborating with medical, pharmacy, and nursing schools, as well as teaching hospitals. And the FDA’s Division of Drug Marketing, Advertising, and Communications will continue to visit trade shows for various professional medical groups.
In toutings its accomplishments, the FDA cited these examples of notices that were sent after reviewing complaints: warning letters for a website promotion; a promotional piece touting overstated product effectiveness; inappropriate statements made by a Forest Laboratories sales rep; a promotional video posted by a Warner Chilcott sales rep on YouTube, and a Shire Pharmaceutical promotional magnet that hid risk info.