FDA To Docs: Tell Us About ‘Bad Drug Ads’
12 CommentsBy Ed Silverman // May 11th, 2010 // 12:26 pm
If you’re a doctor, the FDA wants your help in identifying ‘bad’ advertisements for prescription drugs. Seriously. The agency is calling it’s new ‘Bad Ad’ program an educational outreach effort and, not surprisingly, it’s being run by DDMAC, the agency’s Division of Drug Marketing, Advertising, and Communications, which issues all those warning letters and violations.
The goal of the program is to “help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” DDMAC director Tom Abrams says in a statement. Usually, the FDA finds ‘bad ads’ by reviewing promotional materials submitted for agency review, fielding complaints (often one company sniping at another) and scouring medical conventions. But Abrams acknowledges the FDA has limited ability to monitor promotional activities that occur “in private.”
So now if a doctor, nurse or another healthcare provider spots something eggregious, they can contact the FDA directly from the privacy of their own office (or even when golfing). For instance, all one has to do is write badad@fda.gov or call 877-RX-DDMAC. To see more details, look here. Given that some docs continue to harbor annoyance, if not anger, over direct-to-consumer ads, this is their chance to get even. And drug-company employees should have still more fun pointing out a rival’s violations.
Doc1817
This is potentially a great program. I have already been in touch about what I believed was a promo violation, and, to this point, folks were very helpful and responsive.
Dan
Yes, but it asks the question as to whether or not the FDA is competent enough to identify ‘bad’ drug ads in the first place
patrons99
Why not simply outlaw all DTC advertising just like most of the rest of the world has already done? Only New Zealand and the U.S. allow DTC advertising. DTC advertising, including illegal off-label promotion, poses a “clear and present danger” to public health. The U.S. Supreme Court needs to reach the issue. Just think of all the FDA regulatory overhead that could be saved without DTC ads.
pharmavet
It took me five years in Clinical/Regulatory affairs in a major pharmaceutical company, regularly reviewing promotional material to feel reasonably adept at interpreting DDMAC regulations concerning concepts like fair balance, branding, superiority claims, etc. I had to be adept because I was approving or disapproving promotional material that could potentially represent millions of dollars in drug sales. In my experience, 95% of the violative material that I had found was subtle in nature, and I am highly doubtful that anyone, MD or otherwise would be able to pick up anything other than that 5% which represent the most egregious examples. FDA should better spend their money in hiring more people in DDMAC, which is chronically understaffed.
SteveM
A DDMAC warning letter and 2 bucks will get you a cup of coffee.
The guys in Big Pharma marketing and promotion laugh all the way to the bank with a stream of oily messaging.
They can play whack-a-mole with FDA until patent expiration.
essay writer
I really think government should outlaw all DTC!
former pharma whistle blower
I think with a little coaching you would be surprised how easily the illegal detailing can be caught. I coached a few physicians and they started directly telling the reps their detail was illegal. THere were a lot of very red faces and it was useful in stopping the illegal activity. RIght now the reps don’t think the physcians know when the rteps are tricking them. THen you have the problem with management tricking their own sales force and fraudulant science in journal articles. What rep would think his own management is lying to him and tricking him to mislead a physician?
research writer
The DTC ads issue is multifaceted. With all the challenges that the DDMAC faces, it is too much to expect that they would be able to enforce all regulations that govern DTC advertising. I concur that these ads should be banned.
Insurance Medical
I really like this plan of action. Not only is it user friendly(think ease of reporting bad ads), but it also helps keep advertisers accountable. Accountability coming from the customer base none the less. You could not ask for a better feedback scenario. Everyone benefits from this kind of a program. Doctors, patients, and drug companies alike. Well done FDA/DDMAC.
Bytesland
A study published in the current issue of the journal Annals of Family Medicine examined 38 different pharmaceutical advertisements that ran during peak television viewing times. Researchers found that while the overwhelming majority of the ads made arguments for the use of drugs, only about a quarter of them described the causes of the medical conditions the drugs are designed to treat.
Jessy Lampen
I recently read the new version of the book and found the examples quite interessting. The Bad Drug Ads were quite entertaining.
united health one
there should have been a phrama reform bill instead of a health insurance reform bill because these pharma companies are creating big problems.