F.D.A. nominee Califf’s ties to drug makers worry some

FDA

20 September 2015 - At a DoubleTree Hotel in Durham, N.C., in May 2014, Dr. Robert M. Califf gave a presentation to a group of biomedical researchers, lawyers and industry experts. He spoke about ways to quicken the pace of biomedical innovation by transforming research. Toward the end he showed a slide that noted one barrier: regulation.

It was just a passing reference, barely noticed by the small group in the room. But now, after President Obama nominated Dr. Califf on Tuesday to become the next commissioner of the Food and Drug Administration, his thoughts on the subject are suddenly taking on importance.

Dr. Califf, a cardiologist, is a renowned clinical researcher who has deep respect for the system in which he works, and no one who knows him thinks he wants to weaken the regulatory agency he has been chosen to lead. But he has deeper ties to the pharmaceutical industry than any F.D.A. commissioner in recent memory, and some public health advocates question whether his background could tilt him in the direction of an industry he would be in charge of supervising.

The answer is important because, if confirmed, Dr. Califf will be steering a vast and powerful federal agency that regulates about a quarter of every dollar spent in the United States. It is at the center of some of the most difficult health policy questions facing the country. A crucial decision on how to regulate electronic cigarettes is expected this fall, and Congress is halfway through a substantial overhaul of the way the agency approves drugs and medical devices.

For more details, go to: http://www.nytimes.com/2015/09/20/health/fda-nominee-califfs-ties-to-drug-industry-raise-questions.html?emc=edit_th_20150920&nl=todaysheadlines&nlid=20088616&_r=0

Michael Wonder

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Michael Wonder

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Medicine , US , Regulation