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Personal Tinge to Faster Approvals

Drug approvals at the US Food and Drug Administration sped up recently, the New York Times reports. The average decision time for drugs filtering through the Office of Hematology Oncology Products has dropped from six months to five months, it adds.

The timing of this faster decision-making coincides with Mary Pazdur's three-year struggle with, and ultimate death due to, ovarian cancer — the director of the Office of Hematology Oncology Products at FDA was her husband, Richard, the Times says. Patient advocates, who had derided him previously as a "bureaucratic obstructionist," say that such experiences change a person, leading him to be more open to approving new, riskier treatments.

"I have a much greater sense of urgency these days," Richard Pazdur tells the Times. "I have been on a jihad to streamline the review process and get things out the door faster. I have evolved from regulator to regulator-advocate."

While he notes that his wife's struggle with cancer is part of what's driving him, Pazdur also points out that Congress passed a law in 2012 that allotted FDA more money and enabled the agency to work more closely with drug developers. At the same time, he adds that genetic research has enabled the development of more effective and easier-to-test therapies.

Some, though, are uneasy about this accelerated pace of approvals, the Times adds.

"I respect Rick Pazdur enormously," Fran Visco, president of the National Breast Cancer Coalition, tells the Times. "But I am worried that the FDA is losing sight of the incredible importance of making sure drugs save lives."