Changing of the Guard at FDA: Is Califf the Next Commissioner?

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"Under Margaret Hamburg's watch, the FDA instituted a slew of programs designed to speed up the review process for new drugs, and 2014 saw the agency approve a 20-year-record 51 novel therapies."

FDA Commissioner Margaret Hamburg is set to step down, according to Reuters, weeks after appointing a deputy many believe to be her hand-picked successor.

Hamburg, who has held the agency's top spot for nearly 6 years, will announce her resignation Friday, Reuters' sources say, with FDA Chief Scientist Stephen Ostroff filling her position until a permanent replacement comes in. Robert Califf, a Duke cardiologist slated to begin his tenure as deputy commissioner this month, is widely viewed as the likely candidate for that position, and his January appointment may have been Hamburg's attempt to get an amenable party in place before a new administration takes over in 2017.

Hamburg, a former head of the New York City Health Department, will leave behind a legacy of working closely with the industries she regulates. Under her watch, the FDA instituted a slew of programs designed to speed up the review process for new drugs, and 2014 saw the agency approve a 20-year-record 51 novel therapies.

That's a testament "not just to our expanding understanding of human biology, the biology of disease and the molecular mechanisms that drive the disease process, but also to FDA's innovative approaches to help expedite development and review of medical products that target unmet medical needs," Hamburg wrote in a blog post earlier this week.

Califf, if appointed commissioner, would seem to share her vision of an agency engaged with its subjects. He has straddled the line between academia and industry throughout his career, serving as the founding director of the Duke Clinical Research Institute, a school-funded CRO that employs more than 1,000 people and has an annual budget of more than $100 million. He later went on to run the Duke Translational Medicine Institute, which works with the National Institutes of Health to turn lab discoveries into actionable medicines.

Naming him deputy commissioner last month, Hamburg said in a statement that Califf's "deep knowledge and experience in the areas of medicine and clinical research will enable the agency to capitalize on, and improve upon, the significant advances we've made in medical product development and regulation over the last few years."

In an email to FDA staff obtained by CNN, Hamburg confirmed her resignation, saying it is with "mixed emotions" that she steps down from her post.

"As you can imagine, this decision was not easy," Hamburg wrote. "My tenure leading this agency has been the most rewarding of my career, and that is due in no small part to all of you—the dedicated and hard-working people that make up the heart of this agency. While there is still work ahead (and there always will be), I know that I am leaving the agency well-positioned to fulfill its responsibilities to the American public with great success."

Damian Garde
FierceBiotech

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