Naming veteran regulator Richard Pazdur to head the Food and Drug Administration’s Center for Drug Evaluation and Research is fantastic news for patients, drug companies, and anyone who cares about a rigorous, data-based FDA.
It is the best news the FDA, which has been going through a period of turmoil, has had in a while, and a move long overdue. It’s a good decision by the Trump administration, and one the previous administration should have considered, too.
Pazdur has been more successful than any other regulator at approving new treatments more quickly, on less data, without sacrificing rigor. Just as important, he moved quickly to remove cancer treatments that were approved early but then proved unsafe or ineffective. When the agency has stumbled, it has often been because it failed to learn the clear lessons he set out for how to handle accelerated approvals. If other FDA officials had followed Pazdur’s example, some of the most controversial medicines approved early might not have been.
His story is the stuff of biotech legend. Pazdur has been the FDA’s top cancer drug regulator since 1999, and was originally known by patient groups as “Doctor No” for his exacting standards for clinical evidence.
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