(877)RX-DDMAC – What Happens in the Doctor’s Office, May Not Always Stay in the Doctor’s Office

May 11, 2010

By Dara Katcher Levy

On May 11, FDA announced the launch of the “Bad Ad Program,” an effort to educate Health Care Professionals on misleading prescription drug promotion and provide them with an easy way to report it (just dial 877-RX-DDMAC).  The program, which begins this month, will be rolled out in three phases:  In Phase 1, DDMAC will exhibit at major medical conferences to engage HCPs and distribute educational materials. Phases 2 and 3 will expand this initial effort and update the educational materials developed for Phase 1. 

FDA is primarily looking to gain insight into promotional activities that occur in the privacy of the doctor’s office, and may not be the subject of hardcopy materials submitted and reviewed through Form 2253.  Clearly, FDA sees HCP reports as a means to increase surveillance over pharmaceutical promotional activities, and is attempting to increase the frequency with which they receive these reports.  HCP reports have already spurred a number of letters; one of the more recent is an Untitled Letter to Astra Zeneca from December 2008 about misleading sales representative statements that solicited a request for more information about an off-label use for Seroquel. 

Although reports can be submitted anonymously, FDA is encouraging providers to include contact information so that DDMAC officials can follow-up, if necessary.  After receipt of a report, DDMAC will evaluate it to determine if it meets the criteria needed to take a regulatory action.  For violative promotional activities, FDA represents that DDMAC will move forward with a “risk-based enforcement strategy,” which may include an Untitled Letter, Warning Letter, or referral for criminal investigation. 

To any pharmaceutical company that included, as part of its evaluation of its promotional activities,  whether or not the material would be a “leave-behind” -  this may be a game changer.

Categories: Drug Development