Hoping to streamline the approval of biotechnology drugs, the Food and Drug Administration will transfer responsibility for their review to one of its long-established units that currently evaluates only conventional pharmaceuticals.

The move was hailed by the biotech industry, which has argued that the existing review process is too cumbersome and takes too long. Critics say a speedier process could be dangerous to patients, and some question whether the reorganization will quicken the approval of biotech drugs.

The FDA reorganization will shift the approval process for biologics -- drugs produced from living sources like microorganisms -- out of a specialized office that had been criticized by biotechnology groups for issuing decisions more slowly than the conventional drug unit.

FDA Deputy Commissioner Lester Crawford said that by consolidating review of all new pharmaceuticals in the Center for Drug Evaluation and Research, the FDA will review all experimental drugs "promptly and rigorously in an accountable and consistent manner."

The unit that now reviews biologics, the Center for Biologics Evaluation and Research, will retain jurisdiction over vaccines, blood safety, gene therapy and tissue transplantation.

Carl Feldbaum, president of the Biotechnology Industry Organization, said the established drug review unit is not only better at meeting timetables than the biologics section, but also issues clearer guidelines for the scope of clinical trials. A time line for the reorganization will be developed by January.

"Although the details and their full implications have yet to be determined,

we are pleased with the Bush administration's efforts to bring life-saving drugs to patients faster alongside greater consistency in the drug development and review process," Feldbaum said.

The drug industry watchdog group Public Citizen, however, warned that the conventional pharmaceuticals unit could be subject to political pressure to speed up approvals of novel, high-tech drugs that by their nature should be subjected to diligent safety scrutiny.

"These are, after all, complex and new molecules," said Public Citizen spokesman Peter Lurie. "It's not surprising that it would take a lot of effort to review them."

One analyst is betting that the transfer of

biologics to another unit will have no impact on the speed of their review.

Patrick Mooney, a biotech analyst for Thomas Weisel Partners in San Francisco, said the FDA's conventional drug unit has faster average review times only because many of the drugs it reviews are familiar "me-too" versions of the approved, chemically synthesized small molecules that end up as the pills or tablets most people are used to taking.

In fact, Mooney said, review times for biologics might end up taking longer because the traditional pharmaceutical review unit will tread carefully with high-tech drugs produced by genetically engineered bacteria or tissue cultures.

Walter Moore, vice president of governmental affairs for Genentech Inc. of South San Francisco, acknowledged that the complexity of protein-based biotechnology drugs may add to their review time no matter who evaluates them. But he said the FDA is on the right track with the drug unit consolidation.

"If it achieves clarity and consistency, it's a good thing for our patients, " Moore said.