FDA Policy/General

WSJ Editorial Urges Quick Gottlieb Confirmation

A Wall Street Journal opinion piece has dismissed Democrat lawmakers’ criticisms of FDA commissioner-nominee Scott Gottlieb’s close ties to industry, calling for his quick confirmation. Democrats criticized the nominee’s industry investments and consulting roles during a 4/5 Senate confirmation hearing (see our coverage here), which the WSJ called the “conflict of interest” of knowing too much about the industries he’d regulate. “These are the same committee Democrats who pummeled Betsy DeVos [Department of Education secretary] for not having enough experience in public education,” it noted.

The editorial also took issue with criticisms that Gottlieb won’t address the opioid crisis because of his work with firms that make painkillers. “Yup — he wants to take a pay cut and subject himself to bureaucratic hassles so he can peddle pills to addict more Americans,” the opinion piece said. “Who writes this stuff? In fact, Dr. Gottlieb called opioid abuse ‘a public emergency on the order of Ebola and Zika’ and suggested an ‘all-of-the-above’ strategy that would include inventing less addictive painkillers and better patient care.”

The piece concluded by noting Gottlieb’s past articles about how FDA can “unleash innovation without compromising public safety, which he rightly calls a ‘false dichotomy.’ Democrats once believed in expertise, and if they cared about delivering cures for patients as much as they fret that someone is making a profit, they’d confirm Dr. Gottlieb in a millisecond.”

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