Badrul Chowdhury, director of the U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER)’s Division of Pulmonary, Allergy and Rheumatology Products, has left the agency to take a position as senior vice president of research development at AstraZeneca and MedImmune.
Chowdhury has been with the FDA for 20 years, since 1997. Prior to joining the FDA, Chowdhury was an assistant professor in the Department of Medicine, Division of Allergy and Immunology at the University of Tennessee College of Medicine. He received his Bachelor of Medicine and Bachelor of Surgery at the University of Dhaka, in Dhaka, Bangladesh, and received his PhD in Immunology from the Memorial University of Newfoundland, St. John’s, Newfoundland, Canada. He took his Internal Medicine Residency at Wayne State University School of Medicine in Detroit, and then an Allergy and Immunology Fellowship with the National Institutes of Health, National Institute of Allergy and Infectious Diseases.
At AstraZeneca, he will be directing the Respiratory, Inflammation, and Autoimmunity, Innovative Medicine and Early Development Biomed Unit.
Chowdhury is just the latest high-profile scientist to leave the FDA for AstraZeneca. In February, Sarah Pope Miksinski, formerly director of the Office of New Drug Products in the FDA’s Office of Pharmaceutical Quality, left for AstraZeneca. Last July, Geoffrey Kim, the FDA’s director of the Division of Oncology Products, moved to AstraZeneca as its vice president of oncology and head of oncology strategic combinations.
Other top FDA staffers have left as well. In December, Jean-Marc Guettier, director of FDA’s Division of Metabolism and Endocrinology Products joined Sanofi. Niraj Mehta, associate director of the FDA’s global regulatory policy joined Merck as a director in March 2018. Thomas Cosgrove,director of Office of Manufacturing Quality in the Office of Compliance at FDA left in November 2 017 for Covington & Burling, a law firm.
There has often been controversy over FDA officials’ ties to the pharmaceutical industry. In 2016, a former deputy director, Gordon Johnston, of FDA’s Office of Generic Drugs settled charges that he’d provided tips about approvals to three hedge fund managers, who then went on to make millions of dollars off the information, which was not public. That was just one example.
It’s easy to argue that industry ties should be a requirement for scientists making decisions about industry products, while at the same time it’s understandable that conflicts of interest could be a problem.
The Regulatory Affairs Professionals Society (RAPS), notes, "And this isn’t the first time an FDA official has been charged with insider trading. In 2012, Cheng Yi Liang, a former FDA chemist was sentenced to five years in prison for engaging in insider trading on multiple occasions based on material, non-public information he obtained in his capacity as an FDA scientist."
The FDA often depends on industry funds for its work and hires industry expertise to inform guidance documents and decision-making processes. It’s not unusual, and there is a similar argument that because laws are so complicated, especially when it comes to technical regulatory issues, that lobbyists often play a significant role by providing expertise in these issues, and often are involved in writing the laws themselves.
Still, it makes it easy for corruption to filter in. In 2015, the European Medicines Agency (EMA) updated rules for its scientific committee members and experts that restricted the government assessment teams from taking jobs in the pharmaceutical industry. "The effective management of conflicts of interest is key to ensuring the independence and integrity of the Agency’s scientific recommendations," said Noel Wathion, EMA’s Chief Policy Adviser, in a statement. "EMA continually reviews its policy to ensure that the rules are fit for purpose.
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