Breaking ranks

Divisions in the industry over how to deal with the issue of follow-on biologics are threatening to become highly public, as the Biotechnology Industry Org-anization's efforts to craft a compromise position hasn't bridged the differences between companies that have opposing commercial interests. As a result, a rump group has formed that is pursuing its own agenda.

The fragmentation is likely to become apparent at congressional hearings planned this week "on the law of biologic medicine," where lawmakers have chosen not to invite testimony by BIO and the Pharmaceutical Research and Manufacturers of America. The Senate Judiciary Committee hearing, scheduled for Wednesday, will include representatives of innovator and generic drug companies as well as Acting FDA Commissioner Lester Crawford and FDA Chief Counsel Dan Troy...