Why no Bad-Ad Program letters?
OPDP's Bad Ad Program, which launched in May 2010, was meant to help physicians spot misleading drug promotion and offer an easy way to report the activity. But four years on, some question its impact.
While two dozen enforcement letters were sent by FDA's Office of Prescription Drug Promotion to pharma companies last year, up from 21 in 2012, none of the letters were prompted by the Bad Ad Program.
“Have healthcare providers stopped reporting misleading activities to the FDA, or is there another explanation for the decline?” asks Porzio LifeSciences's Kim Capone, a senior regulatory analyst who tabulated the figures, in an April note to the advisory firm's clients.
According to Capone, Bad Ad Program letters peaked in 2011 with five, falling to three in 2012 and none in 2013. Enforcement is but one component of OPDP oversight of prescription drug promotion, an FDA press officer told MM&M. “Therefore, one cannot get a complete picture of OPDP's program area by looking at a snapshot of time for enforcement letters.” Capone was not available at press time.
To raise awareness of the program, the FDA last year launched an e-learning CME/CE course to help HCPs and med students learn to identify prescription drug promotion that may be misleading or raise other regulatory issues and report it, offering several case studies based on enforcement letters.