FDA Policy/General

FDA Operations Chief Announces Retirement

After a year at the agency, FDA deputy commissioner for operations and chief operating officer Barclay Butler has announced his retirement in the coming months, according to an internal email. FDA commissioner Marty Makary has named Butler’s deputy, Melanie Keller, to assume his duties effective 4/6.

Before joining FDA, Butler ran Barclay Consulting Services as an independent consultant. He spent just over a decade of his career with the Defense Health Agency serving in positions of increasing responsibility, most recently as Assistant Director for Support. From 2012 to 2014, Butler was Director of the Interagency Program Office with the Department of Defense. Earlier in his career, he was Chief Information Officer for several organizations, including for the Office of the Army Surgeon General, the U.S. Army Medical Research and Materiel Command, Walter Reed Army Medical Center, 18th Medical Command, and 44th Medical Brigade at the 18th Airborne Corps.

Makary also announced an additional change within FDA’s operations office. Melissa Shea will become the agency’s principal deputy associate commissioner for operations and deputy chief operating officer, replacing Keller. Shea has more than two decades of experience in program management and health system operations. Before joining FDA, she held senior leadership roles at the Defense Health Agency, where she oversaw a contracting portfolio exceeding $5.3 billion and helped manage the $26 billion TRICARE health insurance program for military personnel and their families.

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