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FDA Seeks To Hasten Review of Biotech Drugs

(Saturday, Sept. 7, 2002 -- CropChoice news) --

The Washington Post, 09/07/02: Some new drugs developed through biotechnology will be approved in the future by the Food and Drug Administration's drug evaluation center rather than its biologics center, the agency announced yesterday.

Many biotechnology companies have recommended the shift, saying the agency's drug evaluation center is better staffed and can review the applications more swiftly.

FDA officials said the move makes sense because the testing, evaluation and use of the pharmaceuticals is similar, whether the drugs are created through traditional chemical means or through newer biotechnology.

While the Center for Biologics Evaluation and Research will lose its review authority over the drugs created through biotechnology, it will maintain control over vaccines, blood safety, gene therapy and tissue transplantation.

In recent years, the Center for Drug Evaluation and Research has gained in industry respect because of its relative speed in reviewing applications. It was the first center at the FDA to be given additional staff and funds through the user fees that drug companies have paid since 1994 when they apply for approval to sell their products. The biologics center will not begin receiving user-fee funds until next year.

Carl Feldbaum, president of the Biotechnology Industry Organization, said his group welcomed the change, which he said reflected concerns that were raised when the user-fee legislation was reauthorized over the summer.

"The industry has been impressed with [the drug center's] close attention to review time clocks," he said, adding that the biologics center did not have as good a record... http://www.washingtonpost.com/wp-dyn/articles/A48047-2002Sep6.html