More than three years since the debut of FDA’s Bad Ad program, the agency has fulfilled a pledge to expand it with a web-based CME course and case studies representing common problems.
The Bad Ad program, launched in May 2010 by the Office of Prescription Drug Promotion (then going under the moniker DDMAC), is designed to spot false or misleading drug promotion by enlisting the medical community’s help.
Soon after its debut, the program began generating reports and Warning Letters. After just one year, reports concerning promotion had tripled compared to the year before Bad Ad was unveiled, including 188 from HCPs and 116 from consumers. Many of these cleared the bar for comprehensive review, demonstrating a grasp of what constitutes misleading promotion, officials said at the time.
And one year out, two Warning Letters had been prompted by a Bad Ad complaint.
Officials had said that a web-based continuing education program was in the works, “based on overwhelmingly positive feedback.”
In a post yesterday on the agency’s FDAVoice blog, OPDP director Tom Abrams finally announced the launch of that e-learning course and case studies as part of Bad Ad. These are designed “to raise HCP and HCP students’ awareness of misleading prescription drug promotion and other common regulatory concerns,” according to a description on the Bad Ad website.
The new course, offered in association with professional portal MedScape, offers 1.0 CME credit for physicians and 1.0 CE credit for other HCPs. Although the target audience for the course is HCPs, OPDP said anyone can take it.
“We encourage medical, pharmacy, nursing and other healthcare related schools to incorporate these cases into their coursework,” Abrams noted. “The cases cover a range of promotional materials including a website, journal ad, and TV ad, and touch upon numerous promotional practices that don’t comply with our regulations.”
Of students, Abrams said that OPDP wants to make them “discerning readers of drug promotional information.”
So far, the real-life examples of misleading drug promotion posted on the site include one to Indevus and Allergan, co-marketers of OAB drug Sanctura, for a journal ad that drew an untitled letter in 2009 for what was described as making unsubstantiated claims and overstating efficacy, and another for Hill Dermaceuticals’ DermaSmoothe/FS website, which drew the more serious Warning Letter in 2010.
The website suggests users check back often for new case studies.
Asked what’s next for the program, a CDER representative told MM&M by e-mail that, “For the immediate future, the focus of the program will remain on the CME/CE. Phase 3 of the program is in development and will seek to engage industry directly to increase voluntary compliance and responsible promotion.”