FDA Policy/General

Senate Committee Vote on Califf Nomination Delayed

The Senate Health, Education, Labor & Pensions Committee has pushed back a 1/5-scheduled confirmation vote on FDA commissioner nominee Robert Califf until 1/15. No explanation for the delay has been given, but some are speculating on weather effects after the Washington, DC region was slammed by a heavy snowfall on 1/3.

Last month at his confirmation hearing (see story), Califf vowed to be very aggressive in the area of social media medical misinformation. During the hearing, Califf was asked whether FDA needs to take a more active role ensuring that there’s sufficient oversight of direct-to-consumer (DTC) advertising. He strongly agreed there should be more DTC oversight, adding that he and other physicians do not like that there’s advertising of drugs. “So the FDA has to regulate it, and I think we need an across-the-board update and a much more active FDA in terms of getting the right information to the public,” he told lawmakers. “It's right there in the mission statement of the FDA to make an understanding of the science behind medical products and their use for the public. But it's not just advertising done on TV like we are used to seeing. There’s a huge amount of information going on social media that we're going to have to deal with....”

Califf said that, if confirmed, his priorities would be emergency preparedness and response; consumer and patient protection; and modernization and innovation. As his first priority, he said: “FDA must continue to be a strong partner in battling Covid-19, taking into account lessons learned from the pandemic so we can apply them to the ongoing current pandemic so we are ready for the next one.”

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