FDA to reassess policies on unsolicited requests for off-label information: differentiating 'scientific exchange' from 'promotion' is complicated.

Not just drug manufacturers, but patient advocacy groups too, are pushing the FDA to ease its prohibitions on the dissemination of off-label medication (and medical device) information. The situation with regard to Genentech’s Avastin and Lucentis (bevacizumab) is just one reason why. Lucentis is indicated for the treatment of the wet form of age-related macular degeneration (AMD), and Avastin is indicated for cancer. Physicians have been using Avastin instead of Lucentis off-label for treating wet AMD for one main reason: Avastin costs $50 per dose, whereas Lucentis costs $2,000 per dose. However, Genentech is limited in what it can tell physicians, P&T committees, and others about how Avastin works when it is used in an off-label fashion for wet AMD. Michelle H. Rohrer, PhD, Vice President of Regulatory Affairs at Genentech, says: