FDA to consolidate pharmaceutical product reviews

November 1, 2002

Pharmaceutical Representative

The FDA has announced the consolidation of the agency's responsibility for reviewing new pharmaceutical products into its Center for Drug Evaluation and Research.

The Food and Drug Administration has announced the consolidation of the agency's responsibility for reviewing new pharmaceutical products into its Center for Drug Evaluation and Research. Work currently performed by the FDA's Center for Biologics Evaluation and Research will be performed by the CDER.

"FDA's drug and biological product reviews have long been the gold standard for the world," said Lester M. Crawford, deputy commissioner of the FDA. "By carefully combining part of our present biologics review operation responsibilities with our drug review operation, FDA will be optimally positioned to uphold that gold standard."

Though the CBER will no longer evaluate biopharmaceuticals for approval, the FDA said the department will continue to function.

"This consolidation will allow CBER to concentrate its scientific expertise and effort in the crucial areas of vaccines and blood safety," said Crawford. "These are top-priority items critical to our national defense and public health. Moreover, CBER will be able to concentrate its expertise on such cutting-edge biologic scientific areas as gene therapy and tissue transplantation."

The FDA has established a working group to develop an implementation action plan and time line for this consolidation by January. Current FDA policy on generic biologics will not be affected by this decision, and the FDA has advised companies to continue to work with the CBER and the CDER as usual until the FDA announces any change in oversight responsibilities and practices.

BIO approves

The Washington-based Biotechnology Industry Organization has applauded the move, which could mean faster approval times for biotech products.

Carl Feldbaum, BIO president, commented, "BIO and its members will do everything we can to facilitate this transition toward streamlined development and review of biologics, while upholding the current gold standard of safety and efficacy." PR

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