Last year, 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.” 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 agency’s Division of Drug Marketing, Advertising, and Communications (DDMAC), in the FDA’s Center for Drug Evaluation and Research (CDER), administered the FDA-sponsored educational outreach effort. According to FDA’s press release, the program is being 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.” The effort was primarily designed to inform health care providers about what constitutes misleading promotion —from both a legal and clinical perspective — and provide them an easy process for reporting suspected violations to FDA.
After its first year, the FDA released an annual report of the statistics and data it had collected regarding the Bad Ad program. Some of the key highlights from the program’s activities during its first year include:
- FDA Commissioner Margaret Hamburg, M.D., kicked off the Bad Ad Program with a letter to more than 33,000 physicians, announcing FDA’s efforts to “collaborate with health care professionals to address misleading promotion, wherever it occurs.”
- Concurrently, FDA released a press announcement marking the program’s launch.
- DDMAC created an informational video about Bad Ad, citing examples of untruthful and misleading promotions. And how to report suspected violations.
- DDMAC created a Bad Ad brochure designed to educate HCPs about prescription drug promotion.
- Throughout the year, DDMAC representatives staffed exhibits at 15 medical conferences across the country, speaking with HCPs about how they can help stop misleading drug promotion. DDMAC representatives also conducted extended presentations at two U.S. teaching hospitals.
- On April 28, 2011, FDA hosted a live Bad Ad webinar for medical and pharmacy professionals with more than 400 attendees.
All of these efforts were intended to raise awareness in the medical community that HCPs can play a valuable role in helping FDA prevent untruthful and misleading prescription drug promotion. Additionally, of the 328 reports of potentially untruthful or misleading promotion:
- 188 were submitted by HCPs
- 116 were submitted by consumers, and
- 24 were submitted by representatives of regulated industry
FDA noted that prior to the Bad Ad launch, the agency received an average of about 104 reports per year. As a result, FDA asserted that this number and diversity of reports received after the Bad Ad program was launched indicates to the agency “that the program was successful in raising awareness of untruthful and misleading promotion.” However, such an assertion may be premature because FDA did not indicate what outcomes were achieved by these reports (i.e. warning letters, legal action, etc.). In addition:
- Of the 188 reports submitted by HCPs, 87 were identified for a comprehensive review, demonstrating a relatively strong level of knowledge in the medical community about what constitutes misleading promotion.
- Of the 116 reports submitted by consumers, 24 were identified for a comprehensive review.
- Of the 24 reports submitted by industry, 14 were identified for a comprehensive review.
FDA asserted that many of the other reports helped to focus FDA’s surveillance efforts in other ways or were referred to other FDA Centers (i.e., potentially misleading ads for dietary supplements sent to the Center for Food, potentially misleading ads for devices sent to the Center for Devices and Radiological health, etc.).
In addition, the agency also recognized that despite criticism of the programs use of anonymous reporting, only 4% of all reports of potentially untruthful or misleading promotion during the first year of the Bad Ad program were submitted anonymously. What is problematic about the number of reports however is that a recent survey showed that only 30% felt absolutely confident that they were qualified to determine what constitutes inappropriate advertising that could be deemed false, misleading, or off-label.
Consequently, FDA noted that this data indicated success because it has heightened the sense of awareness of misleading promotion among HCPs throughout the health care community and it has created a useful deterrent for drug promoters who might run afoul of regulation absent of such messaging.
Accordingly, FDA noted that the Bad Ad program expects to continue and expand in coming years. Expansion includes the development of a web-based continuing education program. Aligned with the program’s primary goal of educating HCPs, FDA will focus additional efforts on students and early career HCPs. FDA will also be actively seeking opportunities to collaborate with the nation’s medical, pharmacy, and nursing schools to enhance student education and will continue conducting presentations at U.S. teaching hospitals. Future activities will also include continued attendance of DDMAC representatives at trade shows across the country, including those of the:
- American Academy of Physician Assistants
- American Academy of Nurse Practitioners
- American Academy of Family Physicians
- American Academy of Pediatrics
- American College of Gastroenterology
- American Society of Health System Pharmacists
Highlights of Bad Ad Enforcement Actions
- Derma-Smoothe Warning Letter issued 12/03/2010. The first action resulting from a Bad Ad complaint was on a particularly egregious website promoting a product for use in a vulnerable population.
- Infergen Warning Letter issued 03/21/2011. A promotional piece was mailed directly to a clinical pharmacist who was concerned that the information overstated the effectiveness of the promoted product.
- Savella Notice of Violation issued 04/28/2011. This Bad Ad complaint is representative of the types of promotion we hope to curtail in field-based settings. This regulatory action was supported by a signed statement from a physician outlining violative oral statements that were similar to statements made directly to DDMAC reviewers during the same time period.
- Atelvia Notice of Violation issued 05/05/2011. This video footage of a violative product detail that occurred in a physician’s office was posted to YouTube.com. Of note, is that this violation was reported to Bad Ad when the posted video had less than 20 views. As a result of this early reporting, DDMAC was able to prevent the violative video from being viewed by a much larger audience.
- Vyvanse Warning Letter issued 05/06/2011. This Bad Ad report came from an astute nurse, who noticed that a promotional piece that was likely viewed everyday by the office’s HCPs was misleading in that it was designed to hide the important risk information from plain view.
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 must continue to ensure that physicians are trained properly and make careful considerations when evaluating advertisements that many patients and physicians depend on.
Physicians are already busy with patients, conducting research and tests, and dealing with day-to-day activities. As the emphasis in health care access and delivery shifts to better outcomes and coordinated care, doctors may have less and less time to deal with evaluating manufacture rep visits. Accordingly, we should be encouraging doctors to improve patient care first, before worrying about drug reps who are already heavily regulated.