Avoiding collateral damage

A week after Acting FDA Commissioner Lester Crawford announced that review of most therapeutic biologics will move from the Center for Biologics Evaluation and Research to the Center for Drug Evaluation and Research, some information has surfaced on the reasons for the decision, but there is little clarity about how it will be implemented. There is reason for optimism that the move is a plus, given CDER’s reputation for moving faster than CBER. But if consolidation at FDA is anything like a corporate merger, there is sure to be some chaos and inefficiency as people sort out their new roles and responsibilities.

From the perspective of the biotech industry, key issues that the agency must address include defining which products will be transferred to CDER, the transition period and procedures for products currently under review at CBER, and policies to ensure consistency and continuity in reviews (see "The Crucial Definition of a Biologic," A12). ...