STAT+: FDA oncology head wants advisory panels to keep voting on new drugs
“I think we need to vote," said the FDA's oncology chief, Richard Pazdur. "We have to make a binary decision at FDA whether to or not to approve. If we…
CHICAGO — As commissioner of the Food and Drug Administration, Robert Califf has made clear he’d like to do away with the votes that punctuate meetings of expert panels evaluating new drugs for approval. On Sunday, Richard Pazdur, director of the FDA’s Oncology Center of Excellence, took issue with his boss.
It’s true that the FDA has no obligation to follow what the advisory committee recommends, but the votes help, Pazdur said at STAT@ASCO, STAT’s event at the American Society of Clinical Oncology annual meeting. “I think we need to vote,” he said. “We have to make a binary decision at FDA whether to or not to approve. If we are going in one direction, and we hear a unanimous vote against — we have to pause. You have to step back and say, were we wrong on this?”
Califf told STAT in an earlier conversation about advisory committees convened by the agency: “I would like to get rid of voting as much as possible. That’s a habit. It’s not a requirement, and it’s not very useful. I’d like more advisory committees to be about the thinking about the field and the intervention that’s being assessed, not so much the approval decision. That’s an FDA decision, not an advisory committee decision.”
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