Most Docs Are Unaware Of FDA ‘Bad Ad’ Program
10 CommentsBy Ed Silverman // March 4th, 2011 // 11:26 am
Last spring, the FDA began a new effort to encourage doctors to report ‘bad’ advertisements and promotional campaigns for prescription drugs and dubbed it the ‘Bad Ad‘ program. The goal is to make it easy for docs and other healthcare providers to report perceived problems to the agency, which describes the program as educational outreach.
One former FDA official lauded the move. “On balance, the FDA probably feels there’s a lot of violative behavior they simply can not monitor with limited resources,” Arnold Friede, a former FDA associate chief counsel and a former senior corporate counsel at Pfizer, told us at the time. “…if the objective is compliance and not enforcement, then this is an additional incentive for a company to closely monitor and control communications by their sales people. For an enforcement agency, I think it’s an understandable, perhaps even brilliant move from their perspective.”
But what do some doctors think? A poll of 1,132 physicians last fall found almost 91.2 percent would be at least “somewhat likely” to report questionable behavior, according to DoctorDirectory, which works with drugmakers on marketing strategies and runs an online search engine for locating docs. In addition, 86.4 percent support the program and 68.7 percent say it is possible the program will increase the number of complaints submitted.
The responses may encourage FDA officials. On the other hand, the FDA needs to raise awareness - only 30.3 percent knew about the program. And while 35.9 percent are very likely to file a complaint, only 30.6 percent feel confident they are qualified to determine what constitutes inappropriate advertising that could be deemed false, misleading, or off-label. Meanwhile, 72.6 percent have, in the past, questioned a rep about truthful or credible info, but 57.3 percent say being able to file a report anonymously increases the likelihood they would do so.
Two further insights: 75.6 percent believe there is potential for abuse by some healthcare providers who may have a bias against, or dislike of, a specific drugmaker or sales rep. And 63.2 percent were neutral about their views toward colleagues who file a complaint about a questionable promotion of some sort (here is the release).
Insider
Most physcians are not comfortable enough with the rules to really want to file a complaint nor do they want to get into a mess. Besides that the physician and staff are usually friends with the rep. With Bextra we had physicians confronting us that we were off-label detailing directly to us. THat created a stir in our meetings but did not seem to change the managers minds on the directions for detailing. THe only time managers would change their directions is when they received a letter from the home office to stop the directive.Most reps that did not walk the line were quickly gone though some stayed around and were harassed for much larger periods of time. The managers were intent on getting rid of the trouble making rep and staying with the message that their regional directors trained them on. So if it happens to you, you should not report it internally but Google on whistle blower and start talking to Qui Tam laywers. You should not report anything internally as you will be crushed and ignored. Reps and managers often don’t know the rules even after training so don’t expect much from them.
PharmaSpy
Thanks for the reminder. I just sent in a little gem to the FDA.
Sam R.Ph.
Given that most physicians make hospital rounds in the AM and then rush to their office to see patients, the first question should of been - how many physicians actualy read, see or hear “bad ads’?
Insider
I trained some specialist on how to spot off-label marketing from reps and they had no problems spotting it once they were sure what it was. THat is what the FDA is talking about- any comments from reps that are illegal or inaccurate. However their brochure is not that well written to cover those areas well froim what I hear. It is not whenther they have time but whether they can spot it when it happens. They are very interested in kickbacks.
Kickbacks seem to get their attention real fast.
pharma gal
Some statements are easy to identify as off-label like a different dose or different diagnosis recommendation. But some times only a lawyer can parse words closely enough to make the statements in label or off label. You can talk to two different regulatory specialists and they will have different opinions on what is in label and what is off label let alone a doctor figuring it out. Doctors are not that thorough in their knowledge of drugs.
Paul
A funny thing happened at a recent medical convention.
The FDA has had exhibit booths at many recent medical conventions promoting this program. Guess who was the only exhibitor giving away pens and pads?
Yep, you guessed it, the FDA.
Margaret Polaneczky, MD
In an amazing coincidence, I wrote a post today about a particularly bad ad by Essure, a female sterilization device manufacturer. In that post, I copied an email I sent to the FDA to express my outrage, and encouraged my readers to do the same.
Thanks to this post, I knew where to send my email.
I forwarded a link to this post to grand rounds for this week, where we are asked to submit both our own post and the best thing we’ve read this week.
Thanks again,
Peggy
Insider
Makes sense, the contact informaton was probably on the pens and pads. On the comment of Doctor’s are not thorough in their knowledge of drugs. I say it depends on the physician and the drug but generally physcians don’t know about every drug thoroughly.
truth
I recently used the fda program to express my concerns about the Lipitor adds that say “who are you kidding” as part of the Pfizer campaign to discredit diet and excercise (and reinforce the notion that practitioners also dont have to bother trying).
It is a black hole. I got no feedback and the adverts continue.
It raises questions about transparency and the graver question about when fda is going to start actually regulating advertising.
Pharma Rschr
The Bad Ad program is interesting but it is about 10 to 15 years too late. This is simply not where the bulk of bad activities lie. Most (not all) but most major pharma companies are under CIA’s or otherwise certainly know that their active promotion through advertisemnts etc is under constant scrutiny, and they have adjusted their activities to reflect that. In addition, with the increased used of managed formularies, protocols and pathways, the companies have focused their efforts elsewhere.
If you want to understand better where the real concern is and why the FDA continues to miss the mark completely look at the J&J Risperdal story on Pharmalot or look at the Lilly or Pfizer latest settlements and their respective CIAs. It is clear that these cases are not about ads and sales reps. They are about communications to doctors through sham advisory boards, investigator meetings, promotional oriented “publication” programs and the like. And where is the FDA in all of that? Answer: Not to be seen.
Companies have long since shifted their approach. The actions taken to influence a formulary, protocol or pathway committee are completely different. Consultant meetings are structured or low-science heatlh outcomes studies are started to facilitate meetings where the FDA’s rules would not apply and where the companies can operate in more secrecy. Physicians are not going to associate these activities with “Bad Ads” because it’s complex and because they are often playing along — In fact, they are getting paid!
So I think the Bad Ad Program is little more than a big PR stunt that will yeild little results because it is simply too little toolate. It is not targeted at the real concerns in the industry as it operates today. While I am sure there are still “bad ads”, an enormous of amount of much more concerning conduct happens every day right under the agency’s nose. They simply don’t have the legal power (or the competence) to know how to ask the right questions or get the right information.
Despite all the theatrics they display at one conference after another, the FDA remains an agency without the statutory power, without the creativeness and without the competence to provide real and significant oversight in the industry today. Thus, various DOJ offices, the OIG and many of the states long ago jumped in to pick up the slack. The “Bad Ad” Program is a sad and sorry answer to this situation.
In the wake of VIOXX the agency struggled to rebuild credibility in the review and approval process and I think they have gone a long way in that direction. But when it comes to post-marketing oversight and enforcement the agency is still trying desparately to remain relevant and despite a small untick in enforcement, it remains a failed exercise.