FDA Policy/General

FDA Official’s Personal Legal Actions Trigger Ethics Probe

FDA deputy chief of staff Samuel Doran is the target of an HHS Office of Inspector General (OIG) ethics investigation on whether he misled the federal government by using a sham divorce to conceal potential conflicts of interest, according to a Bloomberg report. At issue is the relationship between Doran and his former wife, a general partner at a venture capital firm that invests in some health-related startups. The couple divorced last year, according to the report.

OIG reportedly is looking into whether the divorce was constructed to potentially conceal such conflicts. FDA employees are subject to rules that prevent them, their spouses or children from holding investments that could pose a conflict of interest. It’s possible Doran’s ex-wife would have had to divest assets or wouldn’t have been able to make certain investments if the couple had stayed married, people familiar with the matter told Bloomberg. Doran also would have had to recuse himself from certain duties had they remained married.

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