People, Pharma

Two more top FDA officials hit the exits as an exodus of senior regulators continues

Today will be the last day on the job for two key FDA officials, marking the latest departures in a recent exodus of senior regulators from the agency.

A spokesperson for the agency confirmed that Curtis Rosebraugh, the director of the Office of Drug Evaluation II, and Donna Griebel, who’s headed the Division of Gastroenterology and Inborn Errors Products, are both retiring April 28. They were both part of the Office of New Drugs, under the control of Janet Woodcock since January, 2017, when John Jenkins left after delaying his departure in an attempt to keep her out.

Mary Thanh Hai

Their number twos are now stepping up with temporary appointments. Mary Thanh Hai will be acting director of ODE II and Dragos Roman, the current DGIEP Deputy Director, will be acting DGIEP Division Director.

Traditionally, retiring from a top position at the FDA has meant shifting to plum jobs in industry, as we saw when Badrul Chowdhury jumped ship as director of CDER’s Division of Pulmonary, Allergy and Rheumatology Products to take a job this month as senior vice president at AstraZeneca.

Zachary Brennan at RAPS recently summed up all the goings and goings at the FDA. He reported:

Sarah Pope Miksinski, former director of the Office of New Drug Products in FDA’s Office of Pharmaceutical Quality, left the agency in February, also for AstraZeneca. And last July, Geoffrey Kim, former director of FDA’s Division of Oncology Products moved to AstraZeneca to become its VP of oncology and head of oncology strategic combinations.

Meanwhile, Jean-Marc Guettier, former director of FDA’s Division of Metabolism and Endocrinology Products, left FDA in December 2017 for Sanofi, Niraj Mehta, former associate director for global regulatory policy at FDA moved over to Merck as a director in March 2018, and Thomas Cosgrove, former director of FDA’s Office of Manufacturing Quality in the Office of Compliance, left in November 2017 to join the law firm Covington & Burling.

Regulatory consulting firms like Greenleaf Health also frequently poach former FDAers with decades of experience, including former Office of New Drugs Director John Jenkins.

Scott Gottlieb vowed to lawmakers during his confirmation hearing last year that he would make recruiting a top priority as commissioner of the FDA. It’s not getting any easier.

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