June 14, 2011 — The FDA proclaimed success for the first year of the “Bad Ad” program, through which healthcare professionals are asked to report suspected untruthful or misleading drug promotion to the Division of Drug Marketing, Advertising, and Communications (DDMAC). The program is so successful, says DDMAC leaders, it will be expanded, “based on the overwhelmingly positive feedback and response from the medical community.”

However, some industry lawyers are not so sure. For example, Arnold Friede, who has experience both in the FDA General Counsel’s office and at Pfizer, and who is now in private practice, said this on an industry blog: “I think the news here isn’t so much about what FDA has heard from doctors or about how many letters FDA has sent, but about the in terrorem impact of the Bad Ad program. This program gives companies yet another reason to monitor their promotional behavior,” Friede said. “The FDA is deputizing doctors to become informants. It’s like the old ‘Deputy Dawg’ show, except it’s ‘Deputy Doc.’”

Interestingly, the agency states in the report that the sheer volume of reports is not how it will measure the success of the program. Instead, “FDA’s most important measure of success for this program is the heightened sense of awareness of misleading promotion among HCPs throughout the health care community and the likely useful deterrent this awareness has on drug promoters who might run afoul of regulation absent such messaging.”

Program Expansion Plans

In an annual report released yesterday, entitled “Bad Ad Program: 2010-11 Year End Report,” the FDA states that it “expects to continue and expand its Bad Ad efforts in the coming years.” Expansion activities will include the development of a Web-based continuing education program, a focus on students and early-career health care professionals and the active pursuit of opportunities to collaborate with the nation’s medical, pharmacy and nursing schools to enhance student education, according to the report.

Healthcare marketers also should be aware that DDMAC representatives will continue to attend industry events, including this roster of trade shows:

• 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

At an FDA Webinar in April, Catherine Gray, DDMAC management advisor, said that although DDMAC is charged with regulating print, broadcast and oral communications made by or on behalf of prescription drug companies, it cannot possibly “be in every discussion with every sales rep,” so it is asking healthcare providers to use the agency’s “Bad Ad” initiative to report any marketing activities that could potentially be in violation of FDA marketing rules.

Year One Results

During its first year, the Bad Ad program yielded 328 reports of questionable marketing. Of those, 188 were sent in by healthcare professionals, 116 were sent in by consumers and 24 were submitted by industry competitors; only 4 percent of reports were submitted anonymously. Five Warning Letters were issued by the FDA as a result of these reports.