Biotech companies have been fuming for some time about the handling of Biologics Licensing Applications (BLAs) by the FDA's Center for Biologics Research and Evaluation (CBER). The complaints include prolonged approval times (an average 19.6 months last year for BLAs versus 16.4 months for New Drug Applications reviewed by the Center for Drug Evaluation and Research (CDER)), as well as inconsistencies between the handling of approval applications by CBER and by CDER. A particular sore point concerns CBER's failure to employ Special Protocol Assessments (SPAs)—written contracts between sponsors and the FDA that, by including specifications regarding the design of pivotal studies, make it more difficult for the agency to change the rules midstream. In the five years since Congress authorized the use of SPAs, CDER has entered into more than 120 such agreements to CBER's one.
Indeed, Congress—probably the single most effective motivator for FDA change, good or bad—has made clear its dissatisfaction with the way...