FDA Commissioner Margaret Hamburg to Step Down

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 02-06-2015 17:45


US Food and Drug Administration Commissioner Margaret Hamburg will be leaving her post, effective at the end of March 2015. She was appointed as FDA Commissioner in 2009. Dr. Stephen Ostroff, FDA's Chief Scientist, will serve as Acting Commissioner until a successor is named.

"As Commissioner, my goal has been to shape and support an FDA that is well-equipped to meet the challenges posed by scientific innovation, globalization, the increasing breadth and complexity of the products that we regulate, and our new expanding legal authorities," said Dr. Hamburg in a statement. "I have worked hard to advocate for FDA and our unique and essential mission, including building new partnerships to support our work. The Agency has received numerous votes of confidence with the bipartisan enactment of a series of landmark bills extending our authority in the areas of tobacco, food safety and medical products. In addition, we have achieved a dramatic increase in our budget, from some $2.7 billion in FY 2009 to almost $4.5 billion in FY 2015."

As FDA's Chief Scientist, Dr. Ostroff is responsible for leading and coordinating FDA's scientific and public health efforts. The Office of the Chief Scientist works closely with the FDA’s product centers, providing strategic leadership and support for FDA’s regulatory science and innovation initiatives. Dr. Ostroff joined the FDA in 2013 as Chief Medical Officer in the Center for Food Safety and Applied Nutrition and Senior Public Health Advisor to the FDA’s Office of Foods and Veterinary Medicine. Prior to that, he served as Deputy Director of National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC), where he was also Acting Director of CDC’s Select Agent Program. He retired from the Commissioned Corps of the US Public Health Service at the rank of Rear Admiral (Assistant Surgeon General). Dr. Ostroff was the Director of the Bureau of Epidemiology and Acting Physician General for the Commonwealth of Pennsylvania and has consulted for the World Bank on public health projects in South Asia and Latin America.

In a White House press briefing held on February 5, 2015, White House Press Secretary Josh Earnest acknowledged that the FDA Commissioner is leaving the agency, but that the Administration has not yet named a successor.

"..the President certainly appreciates Dr. Hamburg’s tireless service over the last six years," said Earnest in the press briefing "There are a number of issues that she’s grappled with over at the FDA, and the professionalism that she’s brought to that job has made her very effective as the leader of that agency. She’s leaving a legacy of advancements that include biomedical innovation, modernizing the food safety system, and reducing death and disease caused by tobacco. So she’s got quite a legacy that she’s leaving."

In commenting on whether a successor has been named, he said: "As it relates to her successor, I don't have any announcements on that at this point. Certainly, the President will be focusing on somebody that has the kind of impeccable medical and scientific credentials that they can bring to the job. And when we have more to announce on this, we’ll let you know. I mean, I guess I’ll just say one other thing, that when the President does make an announcement, we’re confident that that individual will , that he will appoint the kind of individual that will merit strong bipartisan support in the Senate.

Prior to taking the top post at the FDA in 2009, Dr. Hamburg was the senior scientist at the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons, from 2005 to 2009., and was the foundation's vice president for biological programs from 2001 to 2005. In 1997, Dr. Hamburg accepted the position of assistant secretary for policy and evaluation in the US Department of Health and Human Services. In 1994, she was elected to the membership in the Institute of Medicine. From 1991 to 1997, Dr. Hamburg served as commissioner of the New York City Department of Health and Mental Hygiene.

Source: White House and FDA


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