Although U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has not yet left his position, his resignation announced earlier this week is already causing the industry to put on their prognosticator hat and see who might take over the top spot at the regulatory agency.
Gottlieb announced his intention to step down from the agency he has helmed for two years earlier this week. The commissioner indicated he was tired of being separated from his family during the week and wanted to spend more time with them. Now the question is who will take over. This morning, STAT NEWS released a scorecard of likely nominees.
Amy Abernathy – In December Amy Abernathy, the chief medical officer of Roche-owned Flatiron Health, was named the Principal Deputy Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA). Abernethy took on the highest position at the regulatory agency that does not require a political appointment. In an interview with Forbes at the time of her appointment, Abernethy said she has always seen government service as a way to foment change through policy and regulation. One of her goals at the FDA is to speed up the collection of data that can be used in clinical trials, she said at the time. It is important to note that Abernathy has only been with the FDA for a couple of months and that may work against her being tapped to succeed Gottlieb.
Ned Sharpless – Another potential contender for the role of commissioner is the director of the National Cancer Institutes. Sharpless, who co-founded G1 Therapeutics, is well known for his deep understanding of oncology and big data. Sharpless previously ran the University of North Carolina’s Lineberger Comprehensive Cancer Center, where he was a physician-scientist, running a lab and treating patients, STAT said.
Brett Giroir – Another name brought up as a potential contender for the role is Brett Giroir, who is currently the assistant secretary for health at the U.S. Department of Health and Human Services. Like others on the list, Giroir has straddled work in the public and private sector. Giroir was the founder and CEO of consulting firm Health Science and Biosecurity Partners. He was also Senior Fellow at the Texas Medical Center Health (TMC) Policy Institute; strategic advisor at the TMCx Innovation Institute; and an adjunct professor of pediatrics and tropical medicine at Baylor College of Medicine, in addition to serving on a number of advisory boards.
Janet Woodcock – Longtime FDA veteran Janet Woodcock certainly knows the ins and outs of the regulatory agency. As the head of the FDA’s Center for Drug Evaluation and Research, she is intimately familiar with new medications coming before the FDA and also has a long-time understanding of the operations of the agency. Woodcock has been with the FDA since 1986. While she has the credentials, STAT noted that most FDA commissioners are not selected from the ranks of career agency employees.
Mark McClellan – A former FDA Commissioner, Mark McClellan also helmed the Centers for Medicare and Medicaid Services. When McClellan ran the FDA during the administration of President George W. Bush, Gottlieb served as his adviser. McClellan currently heads a policy initiative at Duke University and sits on the board of Johnson & Johnson.
It may be some time before the Trump White House puts forward a name to replace Gottlieb as FDA commissioner. It is likely there will be an interim commissioner named while the administration juggles its plans to attempt to lower the costs of prescription medications and fight with a divided Congress over a myriad of issues.