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FDA Deputizes Doctors to Police 'Bad' Rx Drug Ads

Pharma Fears 'Jihads' From Health-Care Pros Opposed to DTC

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NEW YORK (AdAge.com) -- An understaffed Food and Drug Administration is asking thousands of doctors and health-care professionals across the country to serve as Big Brother in an initiative designed to catch misleading drug ads.

But the agency's self-named "Bad Ad Program" isn't going over well with the pharmaceutical and marketing industries, which funnel $4.5 billion annually into direct-to-consumer advertising.

"It's a bit of a publicity stunt that is going to make the agency look bad in the long run," says Peter Pitts, former FDA associate commissioner and global head of regulatory and public policy for Omnicom Group's Porter Novelli.

What the FDA tells people to look for in misleading promotions

Omitting or downplaying of risk. The ad or speaker presentation or sales pitch talks about the efficacy of the drug, but does not include fair balance of risk vs. benefit.

Overstating the effectiveness. The ad or speaker presentation or sales pitch makes claims such as the drug delivers results in as little as three days, when clinical trials showed the majority of patients responded in six weeks (and very few within three days).

Promoting off-label, or unapproved, uses. The ad or speaker presentation or sales pitch makes claims that a drug is effective for a use that is not in the FDA-approved product label.

The "Bad Ad Program," run by the FDA's Division of Drug Marketing, Advertising and Communications, urges doctors to report ads and sales pitches that violate FDA rules. Ostensibly, the program was designed primarily to catch what the FDA can't see -- the behind-office-doors pitches from pharmaceutical sales reps to physicians. But the broad definition of the program allows doctors and medical professionals to report false or misleading ads to the FDA, and to do so anonymously via e-mail to badad@fda.gov or by calling 877-RX-DDMAC.

DDMAC plans on educating doctors and medical professionals on how to recognize a misleading ad.

"Our primary goal during this initial phase is educate physicians not only about what constitutes good, compliant advertising, but also who DDMAC is and what we do," said Bob Dean, a former pharmaceutical sales rep who is now the lead consumer safety officer for DDMAC. "Our materials provide a very basic overview of what the regulations require and a few examples of misleading promotion. At this point, it's about raising awareness in the medical community. Later phases will provide more detailed examples of misleading promotion."

Tepid support
The pharmaceutical industry's trade group put out a statement offering tepid support of the program. "We view today's announcement by FDA as another step to help educate -- and receive feedback from -- health-care providers about prescription-drug advertising and promotion," said Ken Johnson, senior VP for the Pharmaceutical Research and Manufacturers of America.

But not everybody shares the same view. "Let me speak in terms from our industry: From concept to execution, this is a bad idea," said one health-care agency president who asked not to be identified. "It's too open-ended, too many loopholes. This is the FDA's way of trying to combat the fact that they don't have enough people to handle all the work."

For years, one of the complaints has been that the FDA is understaffed to handle the hundreds, if not thousands, of promotional pieces submitted by drug companies and ad agencies for prescription medications. Asked if the program was created to assist the FDA with the amount of pieces to review, Mr. Dean said, "No, this program was created to enhance our surveillance efforts."

In fact, this could lead to more work for the FDA. According to PhRMA guidelines to its member companies, DDMAC must vet all marketing communications for DTC before the ads hit the media. Now DDMAC will have to review any complaint that comes in from its newly branded deputies.

"FDA is understaffed, underfunded and under siege," said Mike Guarini, president of Ryan TrueHealth, Wilton, Conn., and a longtime pharma ad vet who has worked on both the agency side and the drug-company side with Bristol-Myers Squibb. "I recognize the need to do this from an economics point of view, but it opens up Pandora's Box. If you look at some of the programs they put together in the past, they were ill-timed, ill-conceived and poorly executed. You can only imagine how unbridled and messy this can become."

Mr. Dean said it's "premature" to predict the number of complaints and that DDMAC will continue to "act on the most serious violations first."

Misuse of program
There is also a worry about whether some medical professionals will take advantage of their dislike of DTC to pummel the system with reports of misleading ads. "You've got more than a handful of doctors and medical professionals who maintain little to no use for DTC advertising. Christ, just look at any survey," said a brand-marketing director at one of the top five drug-makers, referring to surveys and studies that show some physicians feel pressured by patients to prescribe drugs they saw in an ad. "Tell me some of them aren't going to use this watchdog program to their advantage."

Mr. Pitts agreed. "'Bad Ad' is a bad program because it deputizes people who don't understand the law," he said. "That means many bad things, not the least of which is vigilantism, with doctors who might not like DTC who go on personal jihads on ads they don't like -- ads that very well might be in perfect compliance."

Another issue among industry pros: Anyone can submit a complaint. "How do I know it's a doctor that's making a report and not my competitor?" asked Mr. Guarini.

The "Bad Ad Program" focuses mainly on medical professionals, but the FDA admits that anyone can e-mail or call with a report of a misleading ad. The agency is also running a lesser-known campaign to educate consumers about false or misleading DTC ads called EthicAd. The program is web-based on FDA's site.

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