The FDA announced this week that it is launching a program designed to educate health care professionals so that physicians and others can help the agency prevent the misleading or inaccurate promotion of prescription medications.
The Division of Drug Marketing, Advertising, and Communications, or DDMAC, in the agency's Center for Drug Evaluation and Research intends to increase the effectiveness of its surveillance program, especially with regard to inappropriate activity by pharmaceutical sales representatives in physicians' offices and during presentations to health care professionals.
Thus, the agency's new Bad Ad Program(www.fda.gov) aims to ensure that promotional information
- is accurate,
- balances the risks and benefits of a product,
- is consistent with prescribing information approved by the FDA, and
- includes only information that is supported by strong evidence from clinical studies.
The DDMAC plans to distribute educational materials through partnerships with professional medical organizations. Outreach efforts also will include exhibiting at medical conventions beginning this month.
"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," said Thomas Abrams, R.Ph., M.B.A., director of the DDMAC, in a May 11 news release(www.fda.gov).
FDA Commissioner Margaret Hamburg, M.D., said in a letter to health care professionals(www.fda.gov) that the pharmaceutical industry spends nearly three times as much on advertising to health care professionals as it does on consumer-targeted advertising. Advertising aimed at health care professionals -- which occurs in places such as medical offices, hospitals, pharmacies and medical meetings -- often is beyond the scope of the DDMAC's surveillance efforts.
The DDMAC's monitoring of prescription drug promotion relies on review of industry materials submitted to the FDA, complaints filed by the pharmaceutical industry and field surveillance at large medical conventions, Hamburg said.
"While these efforts are effective, FDA's ability to monitor other promotional activities, which may occur in any number of settings, is limited," Hamburg said in her letter. "With the launch of the Bad Ad Program, FDA seeks to collaborate with health care professionals to address misleading promotion, wherever it may occur."
The FDA said examples of common violations include
- omitting or downplaying the risks associated with a product;
- overstating a product's effectiveness;
- promoting off-label, or unapproved, uses of products; and
- making misleading drug comparisons.
Physicians are encouraged to report potential violations related to drug promotion by e-mail or by calling (877) RX-DDMAC [79-33622]. Reports may be submitted anonymously, but the FDA encourages physicians to include contact information so that DDMAC officials can follow up, if necessary.
The FDA also has a campaign(www.fda.gov) designed to educate consumers about misleading promotions.