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Fast-track drug approval called flawed

THE BALTIMORE SUN

WASHINGTON - The government's "fast track" system for making new medications quickly available to treat the deadliest illnesses has become a route for companies to market drugs without fully proving their effectiveness or safety - either before or after they go on the market, says a congressional report to be released today.

The report found that pharmaceutical companies receiving accelerated approval from the Food and Drug Administration often fail to follow through on promises to do complete field trials and other studies after their drugs reach the market.

The system, created largely in response to the AIDS epidemic, appears to be "broken and failing to ensure patient safety," said the report by the staff of Rep. Edward J. Markey, a Massachusetts Democrat.

An industry trade group said there is no evidence that drug recalls have increased as a result of the accelerated approval process. Under the system, drug makers can get the go-ahead - after an abbreviated series of clinical trials - to market medications for life-threatening illnesses. As a condition of approval, the FDA requires the companies to do fuller studies.

The Los Angeles Times is a Tribune Publishing newspaper.

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