FDA Reviews First Year of Bad Ad Program

After looking back at the first year of its Bad Ad outreach program, FDA judged that the initiative has successfully raised awareness about misleading promotion, according to an FDA press release. The program, which was intended to educate healthcare providers about misleading drug promotions, debuted on May 11, 2010. Since that time, the agency has received 328 reports of potentially untruthful promotion. In contrast, FDA received an average of 104 reports per year before the initiative was launched.

Healthcare professionals submitted 188 of the 328 reports, and 87 of them were identified for comprehensive review. The latter number demonstrates that the medical community has a relatively strong level of knowledge about what constitutes misleading promotion, according to the press release. The agency hopes that doctors’ heightened sense of awareness about misleading promotion will deter drug promoters who might otherwise violate regulations.

Consumers submitted 116 reports to the program, and 24 of them were received a comprehensive review. In addition, representatives of regulated industry submitted 24 reports, 14 of which were flagged for a comprehensive review. FDA considers the number and diversity of reports submitted to be indications of the program’s success, according to the press release.

FDA Commissioner Hamburg started the Bad Ad Program last year by sending a letter to more than 33,000 physicians. In her letter, Hamburg described FDA’s efforts to “collaborate with healthcare professionals to address misleading promotion, wherever it occurs.”

The Division of Drug Marketing Advertising and Communications (DDMAC) in the Center for Drug Evaluation and Research later created a video and brochure to provide examples of untruthful or misleading promotion. Ads that omit information about a product’s risk, promote unapproved product uses, or overstate a product’s effectiveness can be considered bad ads, according to DDMAC literature. During the past year, representatives of DDMAC set up exhibits at 15 medical conferences and spoke to doctors about the program. DDMAC also conducted presentations at two US teaching hospitals.

FDA has issued several Warning Letters as a result of the program. The first one was sent in December 2010 to Hill Dermaceuticals about a website promoting the company’s Derma-Smoothe/FS (fluocinolone acetonide) for use on infants.

FDA will expand the Bad Ad program by developing a web-based continuing-education program. To continue its outreach to healthcare professionals, FDA will focus additional efforts on students and doctors in the beginning of their practices. FDA also plans to collaborate with medical, pharmacy, and nursing schools to enhance student education. In addition, DDMAC representatives will continue to attend medical trade shows across the country.