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Hamburg to resign as FDA commissioner

She has held the role for nearly six years

FDA headquarters White Oak 

It has been confirmed that Margaret Hamburg is planning to resign as FDA Commissioner and will leave the post in March after nearly six years in the role.

Hamburg's role will be held on an interim basis by the FDA's chief scientist – Stephen Ostroff – while the search for a permanent replacement gets underway.

The news was confirmed by the Department of Health and Human Services (DHHS) yesterday, and kicked off speculation about who will take over at the FDA, with Robert Califf – formerly of Duke University and deputy commissioner for medical products and tobacco – featuring in early dispatches.

In an interview with Reuters, 59-year-old Hamburg said that she had decided to step down because of the demands of the job and the length of time she has spent in the top FDA role. The next Commissioner will have to be nominated by President Barack Obama and confirmed by the Republican-controlled Senate.

In her last blog post before the news of her resignation emerged, Hamburg pointed to the ”substantial” achievements of the FDA in 2014, including the approval of 51 novel drugs and biologics, which she noted was the largest annual tally for 20 years.

She also cited the FDA's new strategy on combatting antibiotic resistance, tighter controls on compounding pharmacies and the agency's response to the Ebola outbreak in West Africa, including measures to make experimental therapies available for use in the field.

Hamburg is one of the longest serving FDA Commissioners, with a tenure only exceeded by David Kessler in recent times, and was the second woman to take on the role after Jane Henney, who served between 1999 and 2001.

HHS secretary Sylvia Burwell said in a statement that Hamburg "leaves a legacy of incredible, historic accomplishment at FDA."

Article by
Phil Taylor

6th February 2015

From: Regulatory



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