Devices

Public Citizen Calls for Shuren Probe by OIG

Public Citizen’s Health Research Group is calling on HHS’ Office of Inspector General to launch an investigation into allegations that retiring CDRH director Jeff Shuren failed to recuse himself from potential conflict-of-interest matters involving medical device firms being represented by his wife’s law firm. An 8/20 New York Times investigative article exposed the alleged conflicts of interest in Shuren’s regulatory role and the legal work done by his wife Allison for the same industry at the iconic industry law firm of Arnold & Porter (see earlier story).

“Dr. Shuren signed ethics agreements obtained by the Times that were meant to wall him off from matters involving Arnold & Porter’s business,” the article said. “But it’s not clear how rigorously the ethics agreements were actually enforced… In a review of thousands of pages of court documents and FDA records and dozens of interviews with current and former agency staff members and advocates, the Times identified some clients and several instances in which the Shurens’ roles intersected.”

Public Citizen Health Research Group director Robert Steinbrook is quoted in a release as calling the revelations very troubling. “There are long-standing concerns that the FDA’s regulation of medical devices has been too friendly to industry under Shuren’s leadership and has not prioritized patient safety and the effectiveness of novel medical devices," it says. "The Office of Inspector General at DHHS should formally investigate the allegations in the New York Times article. And the FDA must appoint a new director of the Center for Devices and Radiological Health who has no conflicts of interest and prioritizes patients’ interests.”

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