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FDA Commish to Step Down

The commissioner of the US Food and Drug Administration Margaret Hamburg is to step down after six years on the job, Reuters reports.

"As you can imagine," Hamburg wrote in an email to her colleagues, according to the New York Times, "this decision was not easy. My tenure leading this agency has been the most rewarding of my career."

Hamburg was appointed to the top FDA spot by President Barack Obama and confirmed by the Senate in May 2009. She has been, the Times adds, one of the longest-serving heads of the FDA.

Under her leadership, Reuters says the agency has implemented measures to speed drug reviews — with 51 new therapies approved last year, which it says was the most in about two decades — and sought patient engagement in the drug development pathway. She also promoted personalized medicine at the agency.

Her tenure at FDA wasn't always easy as Hamburg, for instance, once faced the agency's decision to allow Plan B to be sold over the counter to young teenagers being overruled, and later allowed, by the then-Health and Human Services Secretary Kathleen Sebelius and a fungal epidemic caused by drugs made at a compounding pharmacy, Reuters adds.

Hamburg recently hired Duke University's Robert Califf as the deputy commissioner for medical products and tobacco, and he is widely expected to be her successor, the Wall Street Journal says.

Hamburg is to step down in March, the Journal adds.

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