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Accelerated approval process being questioned in wake of Iressa review
As the FDA advisory panel weighs whether or not to pull the AstraZeneca drug Iressa from the market due to recent evidence that the drug may not prolong life and may be deadly to some patients, many are questioning the FDA's accelerated approval program that approves drugs for life-threatening diseases without the rigors of full clinical trials. In an effort to speed the delivery of critical drugs to patients in need, the the program allows drugs to be approved based only on preliminary data and the promise of further studies. One of the challenges to the program is that the post-approval studies required of these products, that must show a product provides a "meaningful benefit," often are not conducted.
The New York Times(3/5)
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