FDA to Consolidate Drug Approvals

[Guest guest]

FDA to Consolidate Drug Approvals

Fri Sep 6,12:52 PM ET

WASHINGTON (AP) - The Food and Drug Administration ( news - web sites) said

Friday it plans to shift responsibility for approving new drugs developed

using biotechnology to its unit that had previously focused on traditional

drugs.

The move was welcomed by industry, which has complained in the past that

reviews of the biological drugs were too slow.

FDA Deputy Commissioner Lester W. Crawford said the change will consolidate

responsibility for all drug reviews under the agency's Center for Drug

Evaluation and Research.

That means shifting the biologically developed products from the Center for

Biologics Evaluation and Research, which will continue to work in areas such

as vaccines and blood safety.

" By carefully combining part of our present biologics review operation

responsibilities with our drug review operation, FDA will be optimally

positioned to ... review novel pharmaceutical products promptly and

rigorously in an accountable and consistent manner, " Crawford said in a

statement.

The change will allow the biologics division to concentrate its scientific

expertise and effort in other areas, he added, including gene therapy and

transplantation.

Carl B. Feldbaum, president of the Biotechnology Industry Organization, said

he is pleased with the move, although the details still have to be

determined. The transfer will " bring lifesaving drugs to patients faster,

alongside greater consistency in the drug development and review process, "

he said.

Crawford established a working group to develop a plan by January to put the

change into effect.