Resources for Food and Drug Administration (FDA)

FDA Cancer Czar Stirs Debate On Agency's Role

online.wsj.com

Over two decades as an oncologist, Richard Pazdur frequently delivered bad news to patients. Once, a dying man grabbed his coat and begged him to try even more chemotherapy. The doctor says he declined, because he believed further treatment wouldn't help. The patient died less than an hour later.

Dr. Pazdur, 55 years old, still makes life-or-death judgments. But now, each one affects millions of Americans. As head of the Food and Drug Administration office that regulates oncology drugs, Dr. Pazdur is the gatekeeper for any new cancer medicine that goes on the U.S. market -- and an estimated 30% of all drugs that are in an advanced stage of development.

Dr. Pazdur's powerful position puts him at the center of some of the biggest controversies in medicine. Tomorrow, he will be in the spotlight again, as an FDA advisory committee weighs whether to impose further restrictions on the blockbuster anemia drugs sold by Amgen Inc. and Johnson & Johnson. Yesterday, the agency posted toughly worded documents on its Web site, asking the panel to consider whether the FDA should remove its approval for the drugs' use in cancer patients.

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