With the debut of FDA's Bad Ad Program in May 2010, FDA looked to healthcare providers to become a new offensive against misleading prescription drug promotion. Simultaneous to the launch of the Bad Ad Program, a Reuter's Article reported the intent of the Bad Ad Program was to “increase regulators reach into the largest area of prescription drug promotion – the private contacts between drug company sales people and prescribers.”
Yet, nearly one year since the launch of the program, DDMAC has issued only two Warning Letters resulting from complaints to the Bad Ad program: first, to Hill Dermaceuticals, Inc., for its website for Derma-Smoothe/FS® in December 2010 and, recently, to Three Rivers Pharmaceuticals, LLC, dated March 21, 2011, for its STATgram promotional material for Infergen®. Neither Warning Letter specifically referenced any private interactions between the sales representative and the prescriber as the genesis for the investigation and ultimate issuance of a Warning Letter by DDMAC. Instead, both letters resulted from seemingly traditional promotional activities. In the case of the Warning Letter issued to Three Rivers Pharmaceuticals, LLC, the STATgram had been provided to DDMAC under cover of Form FDA 2253.
On the heels of its recent Warning Letter resulting from a complaint from the Bad Ad Program, DDMAC will be presenting a webinar titled, "An Overview of FDA's Bad Ad Program," on April 28, 2011, at 12:00 p.m. (ET).” The announcement on FDA’s website indicates this webinar is one in a “series of educational webinars, developed by FDA pharmacists and targeted to the needs of all healthcare professionals and students.”
Has FDA shifted its focus of the Bad Ad program from the private interactions between sales representatives and prescribers to get healthcare professionals to report on more general promotional activities and materials? Is it fair for the FDA to use healthcare professionals to police industry’s promotional activities? Should we expect to see a rise in Bad Ad complaints?