martes, 23 de junio de 2020

The likely heir to an FDA powerbroker brings expertise — and controversy

The likely heir to an FDA powerbroker brings expertise — and controversy

The Readout

Damian Garde & Meghana Keshavan

The (possible) heir to an FDA powerbroker

If you made a list of people in biopharma recognizable by first name alone (perhaps you’re quite bored), No. 1 should probably be Janet Woodcock, the superlatively influential leader of the FDA’s drug division. Woodcock is an industry powerbroker, with a nearly mythic reputation and outsized personality. She’s also 71, which has left FDA experts urgently wondering who could possibly replace her.

As STAT’s Nicholas Florko reports, there appears to be an heir in waiting. Patrizia Cavazzoni, who joined the FDA just two years ago, has been running the FDA’s drug approval operation during Woodcock’s recent sabbatical to focus on coronavirus vaccines. And agency insiders say she’s being groomed to take over whenever Woodcock retires.

Cavazzoni, a veteran of both Pfizer and Eli Lilly, is described by colleagues as a quiet problem solver who has taken on some of the FDA’s thorniest challenges in her short time at the agency. But her close ties to the drug industry have alarmed a few critics. And the task of running FDA drug approvals during the coronavirus crisis could prove daunting, like caring for a “family of eight, and then you have the four neighbors move in with you,” as one former agency official put it.

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