Dr. Margaret Hamburg will resign as commissioner of the U.S. Food and Drug Administration at the end of March, the agency said Thursday.
In a letter to staff, Hamburg thanked colleagues for making her nearly six-year tenure at the FDA "the most rewarding of my career."
Noting her "very mixed emotions," Hamburg told her staff "this decision was not easy," but "I know that I am leaving the agency well-positioned to fulfill its responsibilities to the American public with great success."
Dr. Stephen Ostroff, FDA's Chief Scientist who coordinates the agency's scientific and public health efforts, will serve as Acting Commissioner.
Ostroff joined the agency in 2013 as Chief Medical Officer in the Center for Food Safety and Applied Nutrition. He was also a Senior Public Health Advisor to FDA’s Office of Foods and Veterinary Medicine.
Hamburg said Ostroff "will take on this new role with the same energy, dedication and care," he has shown in previous positions.
Hamburg became the 21st FDA commissioner in May 2009. A doctor, scientist and public health executive, Hamburg was just the second woman to be nominated for the position.
Among her key accomplishments at FDA, Hamburg cited improvements in the area of food safety, making medical products safer and more effective, speeding the development and marketing of breakthrough therapies and medical devices and helping to usher in a new era of personalized medicine.
Hamburg also led the agency efforts to reform the compounding pharmacy industry after 750 people in 20 states became sick in 2012 and 64 later died after getting fungal meningitis from tainted steroids mixed by a compounding pharmacy in Massachussetts.
"I am grateful to Dr. Hamburg for her leadership of the FDA. We worked together to find a solution that would help prevent another compounding crisis," said U.S. Sen. Lamar Alexander, R-TN. "I hope the the president nominates an FDA commissioner who will work closely with Congress on finding ways to get safe medical treatments, devices and drugs to patients more quickly."
Ellen Sigal, Chair & Founder of Friends of Cancer Research, said Hamburg's leadership and commitment to patients were unsurpassed. "She has changed the direction of the FDA, creating an environment of science-based collaboration that has fostered a new era of regulatory science focused on expediting the best treatments to patients," Sigal said.
A graduate of Harvard Medical School, Hamburg completed her residency at what is now New York–Presbyterian Hospital/Weill Cornell Medical Center. She also conducted neuroscience research at Rockefeller University, studied neuropharmacology at the National Institute of Mental Health and later served as an assistant director of the National Institute of Allergy and Infectious Diseases.
An elected member of the Institute of Medicine, Dr. Hamburg became assistant secretary for policy and evaluation at the U.S. Department of Health and Human Services in 1997.
From 2001 to 2005 she was vice president for biological programs at the Nuclear Threat Initiative, a foundation that works to reduce the public safety threat from nuclear, biological and chemical, weapons. From 2005 to 2009, Dr. Hamburg was senior scientist at the foundation.