US FDA commissioner Margaret Hamburg stepping down

After six years as the head of the US regulator the Food and Drug Administration (FDA), commissioner Margaret Hamburg is to step down, prompted by the heavy demands of the job.

Under her leadership, drug and device product reviews have been improved and accelerated and she has instituted a strong spirit of collaboration among agencies and the industry in the US and beyond. She has long been seen as a champion of patients.

The development of a new review process for breakthrough therapies has allowed the FDA to expedite development of drugs and biologics, with almost half of novel drug approvals in 2014 receiving expedited review with a combination of breakthrough designation, priority review and/or fast track status. A new regulatory pathway for biosimilars was also introduced.

Reviewing her time in the post, Hamburg said: “As commissioner, my goal has been to shape and support an FDA that is well-equipped to meet the challenges posed by scientific innovation, globalisation, the increasing breadth and complexity of the products that we regulate, and our new expanding legal authorities. 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 bi-partisan 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 FY2009 to almost $4.5 billion in FY2015.”

Hamburg graduated from Harvard Medical School and had a long career in public health prior to her tenure at the FDA, working at the National Institutes of Health and serving as New York City’s health commissioner.

Current FDA chief scientist Dr Stephen Ostroff will take over as acting commissioner when she leaves at the end of March.

Dr Robert Califf, a cardiologist and researcher from Duke University, who Hamburg appointed as deputy commissioner to oversee the FDA’s drug, medical device and tobacco policy last month, is widely tipped to be a contender for Hamburg’s post.

Whoever does take on the role will be faced early on with the 21st Century Cures Initiative – legislation to overhaul US healthcare regulation – which is being pushed by the Republicans.

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