FDA, Regulatory

FDA names new No. 2 to replace retiring Sherman

The US Food and Drug Administration (FDA) announced Monday that Dr. Amy Abernethy will replace Rachel Sherman as Principal Deputy commissioner of Food and Drugs – the highest position at the agency that is not a political appointee.

Amy Abernathy

Abernethy is the former chief medical officer, chief scientific officer and senior vice president, oncology, at Flatiron Health, which is a unit of Roche. Prior to that she was a professor of medicine at Duke University School of Medicine and ran the Center for Learning Health Care in the Duke Clinical Research Institute and Duke Cancer Care Research Program in the Duke Cancer Institute.

FDA Commissioner Scott Gottlieb wrote in a memo to FDA staff announcing Abernethy’s appointment “She’s a highly regarded thought leader who has held numerous positions of leadership in her fields of interest and distinguished herself for her intellect, her passion for patient care and science, and her collegiality.”

Ellen Sigal, Chair and Founder of Friends of Cancer Research, added: “As a treating physician, not only does she know first-hand the importance and power of the impact the FDA has on patients every day, but she has shown in her many leadership capacities that in order to make true advances, and save lives, you must always innovate with the patient at the forefront. This appointment, in many ways, is a natural progression from the pivotal work that Rachel Sherman has paved the way for since her return to FDA in 2015.”

Dr. Sherman is retiring from FDA in January after serving at the agency since 1989. After 15 years of increasing responsibility in CDER, in 2005, Dr. Sherman moved to FDA’s Office of the Commissioner, becoming Associate Commissioner for Clinical Programs and directing FDA’s Critical Path Initiative.

She later returned to CDER in 2009 and served as CDER’s Associate Center Director for Medical Policy and Director of the Office of Medical Policy, before taking over in her current position after a brief retirement in 2015.

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.

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