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September 16, 2002
Volume 80, Number 37
CENEAR 80 37 p. 8
ISSN 0009-2347


Biologics to be evaluated in FDA's main drug division

FDA has announced that it will shift the review of biotechnology drugs from its biologics division to its main drug division, the Center for Drug Evaluation & Research (CDER).

Currently, CDER oversees traditional pharmaceuticals made using chemical processes. The purpose of the consolidation is to shorten review times for new biologics--drugs derived from living organisms--and to make the review of biologics and traditional chemical drugs consistent.

"By carefully combining part of our present biologics review operations responsibilities with our drug review operation, FDA will be optimally positioned to uphold" its reputation for high-quality evaluations, says FDA Deputy Commissioner Lester M. Crawford.

The Biotechnology Industry Organization praises FDA's decision. "We are pleased with the Bush Administration's efforts to bring lifesaving drugs to patients faster alongside greater consistency in the drug development and review process," BIO President Carl B. Feldbaum says.

One catalyst for this consolidation was a June hearing on the ImClone Systems scandal held by the House Committee on Energy & Commerce. After the hearing, the committee wrote a letter to Crawford saying, "There appears to be a different and better approach to the expedited review of cancer drugs in CDER" than in the biologics division.

Larry Sasich, a pharmacist and research analyst at Public Citizen, says approval times for biologics may have been slower because their manufacture may be inherently very complicated to review. Ensuring the consistency of batches of biological drugs is much trickier than for conventional drugs, which are usually small molecules, he says.


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