Industry exec says FDA approval process too strict

Citing the recent decision by GPC Biotech to withdraw its application for satraplatin, Pharmacyclics CEO Richard Miller says that the FDA is making it too tough to gain approvals for new cancer therapies and other drugs that fight life-threatening illnesses. Writing in The Wall Street Journal, Miller maintains that satraplatin is just the latest in a series of cases where the FDA has been making life too difficult for developers. Only one therapy achieved accelerated approval last year and none have made it through that process so far this year. He calls on the agency to revise its approach to drugs that can save the lives of patients who have exhausted other possible treatments.

- read the commentary from the Wall Street Journal (sub. req.)

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