After Wife's Cancer, F.D.A. Regulator Cuts Decision Time from Six to Five Months (Beyond Years Spent Testing)
(p. 1) BETHESDA, Md. -- Mary Pazdur had exhausted the usual drugs for ovarian cancer, and with her tumors growing and her condition deteriorating, her last hope seemed to be an experimental compound that had yet to be approved by federal regulators.
So she appealed to the Food and Drug Administration, whose oncology chief for the last 16 years, Dr. Richard Pazdur, has been a man denounced by many cancer patient advocates as a slow, obstructionist bureaucrat.
He was also Mary's husband.
In her struggle with cancer and ultimately her death in November, Ms. Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the F.D.A.: a speeding up of the drug approval process. Ms. Pazdur's three-year battle with cancer was a factor, they say, in Dr. Pazdur's willingness to swiftly approve risky new treatments and passion to fight the disease that patient advocates thought he lacked.
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(p. 13) Certainly there has been a change at the powerful agency. Since Ms. Pazdur learned she had ovarian cancer in 2012, approvals for drugs have been faster than at any time in the F.D.A.'s modern history. Although companies go through a yearslong discovery and testing process with new drugs before filing a formal application with the F.D.A., the average decision time on drugs by Dr. Pazdur's oncology group has come down to five months from six months. That is a major acceleration in a pharmaceutical industry where every month's delay can mean thousands of lives lost and sometimes hundreds of millions of dollars in sales that, given limited patent times, can never be recovered.
When asked specifically how his wife's illness had changed his work at the F.D.A., Dr. Pazdur said he was intent on making decisions more quickly.
"I have a much greater sense of urgency these days," Dr. Pazdur, 63, said in an interview. "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."
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(Note: the online version of the story has the date JAN. 2, 2016, and has the title "F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval.")