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July 16, 2007

Debate on biotech drug generics lies ahead

Posted by Angel Gonzalez at 10:57 AM

The House of Representatives voted last week to strengthen the U.S. Food and Drug Administration's rule over drug companies, but the fate of biotech drug generics is yet to be written, according to this Wall Street Journal story.

The House bill must be reconciled with a measure recently passed by the Senate, opening the way to follow-on biologics, as identical copies of biotech drugs are known. Biotech companies -- including many local firms -- dread their coming.

The current Senate bill would allow the FDA to waive clinical trials for generic versions of already approved drugs, something that could eliminate most of the incentive to develop costly therapies and pose a safety risk, opponents say. Supporters say generics could lower health care costs and increase access to life-saving medicines.

"A compromise version of the two measures is expected to be completed in the next few months," the Journal story says.

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