FDA Policy/General

Senate Committee Advances Makary’s FDA Nomination

The Senate Health Education Labor and Pensions Committee voted 3/13 to advance the nomination of Marty Makary as FDA commissioner. It now heads to a Senate floor vote, which is expected to confirm the nomination. The committee voted 14-9 to advance Makary, with senators Maggie Hassan (D-NH) and John Hickenlooper (D-CO) voting with Republicans to support him.

Committee chair Bill Cassidy (R-LA) noted before the vote that the U.S. is at a critical moment in public health because there has been a “loss of trust in public health and science agencies.” He said the people’s trust must be restored by “public health leaders committed to transparency and finding unbiased solutions to Americans’ most challenging health problems.” He said he supports Makary’s commitment to promoting medical innovation while upholding the agency’s gold standard for reviewing products. Cassidy also emphasized the need to address obesity and chronic disease.

Senate Democratic Whip Dick Durbin (D-IL) addressed the Senate floor to thank Makary for meeting with him earlier this week. “The FDA requires a commissioner who is willing to withstand pressure—from Big Pharma, Big Tobacco, or maybe even the president—to protect public health,” he said in his floor address. “We cannot afford an FDA commissioner who gets chewed up by Elon Musk’s chainsaw or stands idly by as RFK Jr. pushes his deadly bias against vaccines. To safeguard and regulate the food we eat and the drugs we use, we need a leader at FDA with the courage to say ‘no.’”

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