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The FDA's Cancer Czar Says He Can't Approve New Drugs Fast Enough


6/24/2013 8:10:25 AM

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Maybe more than any other person alive, Richard Pazdur, the director of the Food and Drug Administration’s Office of Oncology and Hematology Products, personifies the tension between the need to get new drugs to patients fast and the competing desire to make sure they are safe and effective first. To his critics, he is an compassionless bureaucrat who denies cancer patients lifesaving medicines using red tape and fine print. In 2007, Richard Miller, the chief executive of a company called Pharmacyclics whose drug had been rejected, wrote a series of opinion pieces in the Wall Street Journal accusing the FDA of “stifling, rather than encouraging, investments in innovation through cumbersome and over-restrictive policies.” A New York Times profile referred to him as “the man who says no."

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