Has the other shoe dropped?
Following mounting speculation, FDA commissioner Margaret Hamburg has told staffers that she will step down at the end of March, after a nearly six-year run heading the agency. The news comes just 10 days after the FDA hired Robert Califf, a widely regarded Duke University cardiologist, as deputy commissioner for medical products and tobacco.
That move quickly set off speculation that Califf would, in fact, soon succeed Hamburg, since he starts his new job later this month. And his new job involves overseeing a large swath of the agency – the FDA’s Center for Drug Evaluation and Research; the Center for Biologics Evaluation and Research; the Center for Devices and Radiological Health, and the Center for Tobacco Products.
An FDA spokeswoman declined to say whether a search was under way or, if so, how long the process may take. For now, FDA chief scientist Stephen Ostroff will temporarily assume command until a new commissioner receives congressional approval.
Hamburg, who has been one of the longest-serving FDA commissioners, presided over a string of accomplishments and controversies. A key mission from the start of her tenure was to bolster drug safety. There had been scandals over undisclosed side effect data for such medicines as the Vioxx painkiller and contaminated heparin that was imported from China and blamed for 81 deaths. […]
Such backbone will be missed by some, especially now and Hamburg’s departure comes at an unfortunate time, according to Diana Zuckerman, who heads the National Center for Health Research, a non-profit think tank. She worries that a sweeping law Congress is drafting called 21St Century Cures will have a detrimental effect on how medical products are regulated.
“Hamburg has been a strong voice for public health and this is a major loss at a dangerous time for the FDA,” she tells us. “The proposed legislation represents a frightening assault on the agency and the safety of medical products, and the FDA will need a strong leader to protect its public health mission.”
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