"Paging Dr. Draper! Paging Dr. Draper! We have an ad in the examination room that requires your attention, STAT!" The PA system goes quiet. In the waiting room, patients shuffle their feet nervously, waiting, waiting, waiting….
Dr. Draper enters the exam room. His white coat flutters gracefully around his knees. (He scoffs at scrubs and is wearing stylish slacks and a white shirt, with a thin black neck tie.) There on the white crinkly paper on the exam table sits a lonely waiting room flyer put together by a prominent medical product manufacturer. It looks innocent enough. At first, he gives the ad a once-over, then his diagnostic juices start to flow.
"I'm going to have to turn you over," he says gently.
On the front of the ad is a depiction of how the medical product can help a patient. On the back of the ad is the risk information, that is written in considerably smaller print than that of the front. He squints and nods. He puts the ad upright. In the old days, he would have lit a cigarette at this point. Instead, he touches the end of his dangling stethoscope and stares straight at the ad. He squints. "I'm gonna have to turn you in. You have a lack of fair balance, buddy." He turns and reaches for the phone…
Yesterday the FDA launched the "Bad Ad" program. Yes, that is what they call it. The idea is to train and situate physicians to detect and report misleading medical product promotions. The program is set to come out in three phases – the first apparently being to reach out to physicians at medical meetings and to partner with medical societies. The next two phases are a little vague, but essentially involve ramp up. There is a very simple brochure that informs physicians of their ability to spot and report bad ads and there is a very, very simple guide to what is a violation.
Enforcement at DDMAC is certainly on the upswing, of that make no mistake. Already by a quick count, the division has sent 28 warning or NOV letters, which is more than were sent out in most of the last 10 years or so. In fact, if the agency continues on its current path, it will produce well over 60 such letters, which is far more than any year since the years of the Clinton Administration.
But is deputizing physicians a good way to increase scrutiny? Do physicians have time to report the diseases and adverse events they see, much less be on the look out for bad ads? And do physicians want to engage in time consuming activities for which there is no reimbursement?
I understand what the FDA is trying to do, and industry certainly has reached out to physicians to engage them and uses up their time. But industry engages them about medicine that they are going to prescribe for me, the patient. I'm not sure I want my doctor hunting down bad ads. I want my doctor to spend that time moving to electronic medical records (he still uses hand written) or engaging me on line (he doesn't), or taking my call (he does call me back). Does my doctor have time to hunt down bad ads? Frankly, on a cost/benefit ratio, for me the patient, I see the benefit as marginal, while anything taking up my doctor's time that isn't directly related to the quality of health care I get from him is of almost no benefit to me.
I like clothes. I like to buy clothes and wear them and I enjoy picking them out. But every so often, when I'm going through my closet, I come across a tie that I look at and say to myself "What was I thinking?" Under Dr. Hamburg's and Sharfstein's leadership, the FDA has been launching some impressive initiatives (see the interview with Dr. Sharfstein on transparency and accountability, e.g.). that are re-shaping the agency for the better. But the BadAd idea, I can't help thinking, is going to end up like one of my old ties.
But I could be, and often am, wrong. In any case, the FDA has created a special email account – badad@fda.gov and a hotline for tips – 877-RX-DDMAC.
While there is certainly room to criticize FDA’s efforts to turn doctors into government informants, the program itself may be successful from FDA’s persepctive without any doctor ever having to turn in even a single report of a violation. This is because of the substantial deterrent effect that a program of this kind is likely to have, or, in FDA’s view, should have. To the extent that companies perceive that doctors are now more likely than ever to be whistleblowers on “bad ads”, it seems as if there is yet-increased incentive to control sales force behavior. Indeed, the program itself suggests that the Obama FDA remains seriously concerned about pharmaceutical advertising and promotion, particularly what goes on with doctors behind closed doors, despite all of the recent FDA, DOJ, and OIG compliance activity.
Arnie Friede
Arnold I. Friede & Associates
Arnie@FriedeFDALaw.com
Arnie – That is an excellent point and one I meant to cover. Still, I had to wonder isn’t a Warning Letter or an NOV incentive enough not to cross the line?
I would have to say that the FDA has been ineffective in policing current pharmaceuticals that have been produced in the past multiple years. Getting doctors to help them is a creative way of “delegating” but at the same time is the wrong approach. Although the doctors are the more educated, it would be nice to see more patients become more informed and ready to ask questions about any medical product promotions.