FDA's Approvable Problem - Pharmaceutical Executive

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FDA's Approvable Problem


Pharmaceutical Executive


There are other kinds of politics at play too. "At the same time that people are criticizing us about approving drugs too fast," FDA's Jenkins said, "we have a lawsuit being filed against the agency saying that patients should have access to drugs sooner."

In July, after FDA issued an approvable letter to Dendreon for its prostate cancer drug, Provenge (sipuleucel-Tg), asking for more data, the cancer activist group Care to Live went to court. By September, 200 men age 50 and older were marching, with their wives and other supporters, on the agency's headquarters in Rockville, MD. They chanted, waved placards, and acted, most uncharacteristically, like angry young protestors. Their signs read: "Approve Lifesaving Drugs Now" and "FDA: Federal Dinosaur Agency."


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