Often when we think of bad ads, things like the annoying Super bowl McDonalds Fish Filet Sandwich, or the Subway $5 dollar foot long ads come immediately to mind. During the Winter Olympics, I thought the DreamWorks How to Train Your Dragon Ads were right in there. The FDA however is now in the bad ad business.
This week, the Food and Drug Administration (FDA) launched “The Bad Ad Program,” which is designed to educate health care providers about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading.” The FDA-sponsored educational outreach effort is being administered by the agency’s Division of Drug Marketing, Advertising, and Communications (DDMAC), in the FDA’s Center for Drug Evaluation and Research. According to FDA’s press release, the program will be rolled out in three phases.
– Phase 1, DDMAC will engage health care providers at specifically-selected medical conventions and partner with specific medical societies to distribute educational materials; (Brochure) and
– Phases 2 and 3 will expand the FDA’s collaborative efforts and update the educational materials developed for Phase 1.
Thomas Abrams, director of DDMAC, asserted that “The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.”
One reason for the new program, according to Reuters, is for the FDA “to increase regulators' reach into the largest area of prescription drug promotion — the private contacts between drug company salespeople and prescribers.” The idea came from Bob Dean and Mike Sauers, former drug company pitchmen, who now work in the FDA office that polices promotions.
Under current law, prescription drug marketing must be truthful and balanced. To enforce this, FDA staff routinely checks ads on television or in magazines and medical journals, but “it is tough to track closed-door sales tactics such as a chat inside a doctor's office or a sales presentation over a meal.”
The Bad Ad Program
Starting this month, FDA staff will set up booths at major medical conferences to tell doctors how to spot questionable pitches, and they will also send letters to about 33,000 healthcare providers about the Bad Ad Program. The letter told doctors responsible promotions can provide doctors with valuable information about new therapies, but that promotions may also mislead doctors, colleagues, and eventually patients.
The new program is consistent with increased enforcement against drugmakers, in which warnings to companies for problematic promotions have nearly doubled since Obama took office. According to the creators, the goal of the program is to teach doctors "how to be better consumers of information they receive from the drug reps." Examples of violations for doctors to look for include complete omission of risks or minimizing risks. Specifically, the Bad Ad Program requires that a prescription drug advertisement:
- Be accurate
- Balance the risk and benefit information
- Be consistent with the prescribing information approved by FDA
- Only include information that is supported by strong evidence from clinical studies
In addition, the Program lists and gives examples of common violations such as:
- Omitting or downplaying of risk
- Overstating the effectiveness
- Promoting off-label, or unapproved, uses
- Misleading drug comparisons
Physicians can report anything questionable via an FDA phone hotline or e-mail, and the complaint can be anonymous. Once a complaint is received, it will be sent to the Regulatory Review Officer in DDMAC responsible for this class of drugs. The reviewer will evaluate it and determine if it may serve as the basis for a potential enforcement action or as valuable information for our ongoing surveillance activities. To assess complaints, FDA reviewers will be able to spot patterns when they hear similar complaints about the same drug from more than one doctor
FDA staff would then need to verify complaints before taking action, and the agency would send letters to companies when it finds misleading promotions telling them to stop, and sometimes order distribution of corrective messages.
Some groups, such as the American Medical Association, assert that doctors frequently voice concerns to the group about misleading drug promotions. As a result, Dr. Rebecca Patchin, the board’s chair, believes the FDA program "is a helpful avenue for physicians to bring these activities to the agency's attention."
Consumer advocates are also pleased with the FDA was making it easier to report improper promotion but, are still concerned with what the FDA will do about bad ads that have been reported, and how long will it take them to do anything useful. Many believe the agency takes too long to – often months – to respond to improper marketing, something FDA’s Abrams said is the result of the agency’s limited resources, which forces them to focus on the most serious violations first.
Although he thought the new program was a “clever idea”, Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, noted that FDA would need adequate funding from Congress to act on all the complaints that might come in.
Sharing the drug maker perspective, Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America called the new program “another step to help educate – and receive feedback from – healthcare providers about prescription drug advertising and promotion." He believed this step was important because "companies devote substantial time and effort, and often ask for input from the FDA to ensure that prescription drug communications are accurate and meet all applicable legal requirements."
According to the Washington Legal Foundation; “The very existence of this program could do more to chill the open exchange of health information than any FDA regulation or warning letter.”
Some doctors who find sales rep visits to be unbearable or chafe at consumer advertising might see this, as one commentator put it, as “a chance to get even.” Free and open exchange of information at conventions and other meetings may become a thing of the past if drug and device makers are constantly wondering which physician has FDA on speed dial. Whether FDA likes it or not, product makers have integral knowledge of their drugs, and when such information isn’t shared with doctors, patients lose out.
How is American health care improved when physicians are distracted by the lure of government whistleblowing? As Eye on FDA so appropriately noted:
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 online (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.
While the goals of this program are important and reasonable, as the FDA noted in their letter to doctors, “responsible promotions can provide doctors with valuable information about new therapies.” DDMAC and physicians must be trained properly and make careful considerations when evaluating advertisements that many patients and physicians depend on.
Given the FDA’s continual budget crisis, being relegated to the Agriculture appropriations subcommittee it seems like those limited resources could be used more efficiently elsewhere.