FDA Policy/General

White House Shoots Down Rumored FDA Head Prospect

The White House is denying that a rumored candidate for FDA commissioner, former Obama White House advisor Ezekiel J. Emanuel, is in the running for the agency top job. First reported by Politico, hours later it was denied by White House spokesman Kevin Munoz. “Dr. Emanuel is not in the running for this position,” he told the publication. Emanuel did not rule out being interested in the job if approached, but said he hasn't had any discussions about it. “I don't know where this rumor comes from,” he said, adding that no one in the administration has contacted him.

Brother of former Chicago mayor Rahm Emanuel, Ezekiel Emanuel currently serves as a professor at the University of Pennsylvania and co-director of its Health Transformation Institute. From 2009 to 2011, he served as special advisor for health policy to the director of the Office of Management and Budget in the White House. From 1997 to 2011, he was chair of the Department of Bioethics at the National Institutes of Health.

Dr. Emanuel received his medical degree from Harvard Medical School and his Ph.D. in political philosophy from Harvard University.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome