Devices

It’s Official: Tarver Takes on CDRH Director Post

Physician-attorney Jeff Shuren’s hand-picked successor Michelle Tarver has been given the reigns as the next CDRH director effective 10/22. She takes over as Shuren is receiving increased scrutiny (see story) from Capitol Hill after two U.S. House of Representatives Democrat lawmakers last month called for an HHS Office of Inspector General (OIG) investigation into potential conflict-of-interest appearances (see story) raised in an August New York Times investigative article on the retiring official’s past regulatory role and the legal work done by his wife Allison for the same industry at the iconic industry law firm of Arnold & Porter.

The request for an investigation follows FDA Webview’s 9/23 reporting (see story) that despite Shuren’s departure from CDRH, the same conflict concerns remain with Tarver, who continues a cozy-with-industry corruption of FDA’s patient safety mission at the Center. Similar conflict-of-interest concerns have been leveled at Tarver, an ophthalmologist with strong connections to the Bowie, MD-based LASIK-promoting eye surgery firm of Solomon Eye Physicians and Surgeons, whose Web site advertises her availability for consultations. As physicians, Shuren and Tarver are permitted to see private patients when not on duty at FDA provided that this doesn’t create a perception of a conflict of interest. In Tarver’s case such a perception might be created when she is simultaneously working on medical device company regulatory issues at CDRH.

In reaction to her new post, Tarver said in an email shared with FDA Webview: “I am truly honored to lead CDRH and our talented staff across the Center who are committed to protecting and promoting public health. As someone who has served the FDA for more than 15 years, I am immensely proud of the work we have accomplished together, always keeping the people we serve at the core of our mission.”

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