Pazdur Followed the Pathway of Greatest Resistance to the FDA

Tony Hagen @oncobiz
Published: Monday, Dec 30, 2019
Richard Pazdur, MD

Richard Pazdur, MD

Richard Pazdur, MD, a 2019 winner of the OncLive® Giants of Cancer Care® award for community outreach, education, and cancer policy, set out to be a leader in medicine and a teacher of doctors. He achieved that and more, turning the oncology drugs section of the FDA from a poorly understood and lead-footed division into a fast-moving and patient-responsive entity.

 

FIGURE. New Molecular Entities Approved in Oncology/Hematology From 1999 to Present

New Molecular Entities Approved in Oncology/Hematology From 1999 to Present

“When we make a decision about approving a drug, it has to be patient centered. It can’t be about the regulations,” Pazdur said, describing the philosophy he has championed at the FDA. It did not always seem that way to a skeptical public. Pazdur was once publicly vilified as “Dr Death” for his conservative approach. The Wall Street Journal was particularly critical, publishing a series of editorials that criticized Pazdur for what they felt was an overly conservative approach. “I believe I had my own editorial writer at the Wall Street Journal,” he said. A 2002 editorial headline in the paper read “FDA to Patients: Drop Dead”; and a 2005 editorial was titled “Pazdur’s Cancer Rules.”2,3

Pazdur said he was always as strong a patient advocate as anybody, but experimental drugs had to get the scrutiny they deserved. “I think that many of the drugs that we did not approve just generally should not have been approved. They were classical chemotherapy drugs that had a lot of toxicity and very little evidence of efficacy,” he said.

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