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FDA Moves to Speed Biotech Drug OKs


The Food and Drug Administration announced internal changes Friday that had been sought by the pharmaceutical industry to speed approval of biotechnology drugs.

The agency said that beginning next year, the Center for Drug Evaluation and Research would review approval applications for biotechnology drugs, a job now performed by the Center for Biologics Evaluation and Research. An agency spokeswoman said the shift was being made to "improve efficiencies" in the drug approval process.

The Biotechnology Industry Organization, the lobbying arm of the industry, hailed the move. It said that last year the agency took eight months longer to approve biotechnology drugs than it took to approve other types of medications. Biotechnology drugs are produced in living organisms, such as bacteria or yeast, and typically are administered by injection.

The industry has complained about inconsistencies in the review process for biotechnology drugs. The agency's handling of ImClone Systems Inc.'s experimental cancer drug Erbitux drew scrutiny during congressional hearings that focused on alleged insider trading by the company's former chief executive, Samuel D. Waksal.

Carl B. Feldbaum, president of the biotechnology organization, said the center that will be taking on biotechnology drugs has a reputation for working closely with companies to avoid delays.

"We feel this is a welcome development," Feldbaum said.

However, some analysts questioned whether the switch would result in faster approvals for the drugs.

Patrick Mooney, an analyst with Thomas Weisel Partners, said in a research note that many drugs handled by the Center for Drug Evaluation and Research don't require long reviews because they are "me-too" versions of existing medications. Many of these drugs are chemical formulations that are taken orally, such as anti-cholesterol pills.

Biotechnology drugs, Mooney said, tend to be novel and more complex, such as Amgen Inc.'s product Epogen, which is a genetic copy of the human protein that spurs the production of red blood cells. It is manufactured in mammalian cells.

"It always raises a red flag when the industry claims their new product approvals are too slow," said Larry Sasich, a pharmacist with the consumer group Public Citizen. "Are they slow because their submissions are sloppy and the FDA is asking them to get the applications together?"

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