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The Medicine Maker / Issues / 2016 / Articles / Mar / A New Administration
Business & Regulation Standards & Regulation Business & Trends

A New Administration

Despite controversies, Robert Califf will finally take the reins at the FDA.

03/17/2016 1 min read

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In a vote of 89-4, US senators have confirmed Robert Califf as the FDA’s next commissioner. Califf is a world renowned cardiologist and clinical trials expert who has published over 1200 papers, making him one of the most cited medical authors in the US (1). Prior to joining the FDA, Califf was a Professor of Medicine and Vice Chancellor for clinical and translational research at Duke University. He also served as Director of the Duke Translational Medicine Institute and the Duke Clinical Research Institute – where he led a number of landmark clinical trials in cardiovascular research. But it’s not been a smooth path to the top of the FDA by any means. Califf was nominated for the job by President Obama in September 2015, but concerns were raised about his “close ties” to the pharma industry; Califf has received research grants and consultancy fees from a number of big pharmaceutical companies, leading some to call into question Califf’s objectivity and his ability to curb the growing costs of prescription medicines (2). Despite the controversies, Califf’s nomination has also received a great deal of support from organizations such as the American Heart Foundation and the New England Journal of Medicine.

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References

  1. FDA, “FDA Statement on Senate Confirmation of Dr. Robert M. Califf,” (March, 2016). http://1.usa.gov/20VngvF T. Howell, “Senate confirms Robert Califf, Obama’s pick to lead FDA, despite opioid outcry,” Washington Times, (February, 2016). http://bit.ly/1TvwU9a

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