The FDA: Our Bad Ad Program Is Working
6 CommentsBy Ed Silverman // June 13th, 2011 // 10:09 am
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 (look here).
original industry insider
Those percentages would be significantly better if they included all cases of drug companies ragging on each other’s ads to DDMAC. It’a a competitive business you know,the sharks are always looking for blood, and companies know how to look way beyond the obvious false, misleading promotional claims, etc. and can drill down into the subtleties of promotion that the average physician or consumer would be less inclined to pick up.
In the final analysis we’re a pretty snippy lot.
hospitalist
Imagine if we had a similar program where I could turn in colleagues who run tests and perform procedures because they are incentivized around volume and not because of patient care?
company insider
THe bad add program is a very good idea. When we were marketing Bextra off-label the compliance officers said the phone was ringing off the hook so they knew management was invovled. No rep could generat that many calls they said. If the bad add program had been available then, I bet the phone would have been ringing off the hook also for the FDA. They should also mention reps sending medical and drug information requests to physicans who never requested the off-label data. THat was a favorite way fo the managers at Pfizer to get their reps to go off-label. If you receive Medical and drug requests that you did not request, this would be a great place to report the criminal activity to the FDA, through the bad add program. NOw the FDA appears to be easier to reach though their regional compliance centers were very professionally staffed. No 0ne knew they were there, I guess.
Doc
Great program, only by making CEO’s wonder if their reps are off track will they take steps to stop it. Although since fines are “just the cost of doing business”, jailing a few execs would go along way to stopping this harmful activity.
original industry insider
Great comment company insider. Some people collect stamps; I collect proposed Marketing detail pieces that never made it past our compliance commitee. I’ve got a closet full of them that I use for teaching purposes. Nevertheless some do make it out the door despite our best efforts, and become “bad ads”.
company insider
Dear Original industry insider, that is interesting because I did not understand how some of the detail pieces ever made it past the compliance committee at Pfizer. THeir committees did not seem to be working. It was extremely confusing what they were doing during the time of Bextra. THey would train us we were not aload to talk about that, then train us what we would say if we were aload to talk about it right in the training manuel. THen the managers would direct us to talk about it. It was very confusing to a rep but they did it even if they thought it was illegal for fear of losing their job if they did not comply with the district managers directives. Outrageous, the power of a manager in that company.