FDA Director Moves to AstraZeneca

Regulatory NewsRegulatory News | 18 April 2018 |  By 

Twenty-year FDA veteran Badrul Chowdhury, most recently director of the Center for Drug Evaluation and Research’s (CDER) Division of Pulmonary, Allergy and Rheumatology Products, has taken a job this month as senior vice president at AstraZeneca.

FDA confirmed to Focus that Chowdury joined the agency in 1997 and left on 16 April. And Chowdury isn’t the only one to leave in recent months for an industry job, FDA said.

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.

Questions have been raised in recent years on the revolving door between industry and FDA, particularly as experience at the agency can lead to lucrative salaries and create conflicts where relationships between industry and FDA are already cozy.

Back in 2015, the European Medicines Agency tightened its policy on the revolving door, noting that if necessary, it would begin verifying if previous scientific reviews in which a person jumping ship to industry had been compromised.

On the flip side, FDA relies on industry funds to do its work, often hires industry experts and uses outside expertise from pharmaceutical companies to inform guidance documents and rulemakings.

FDA Commissioner Scott Gottlieb and his predecessor, Robert Califf, were both criticized ahead of their confirmation hearings for being too closely linked to industry, but both commissioners have also shown how their experience can be utilized in the top job.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy