FDA Policy/General

Trump Denies Makary is on the Outs

President Trump is dismissing reports that say FDA commissioner Marty Makary will be asked to resign soon. Late Friday, Trump told reporters he knew nothing about Makary’s job being in jeopardy.

The new week has brought no changes at the agency so far, and Makary continues to be authorizing press releases that quote him. His schedule for the week appears unchanged at the moment, and he is expected to appear at a budget hearing on Capitol Hill on Wednesday and a Financial Times keynote address on Thursday.

Meanwhile, on Monday, former FDA commissioner Scott Gottlieb hinted it was too coincidental that several media outlets were given details about Makary’s potential ouster and then names were being floated on who could serve as commissioner in Makary’s absence. While acknowledging some of Makary’s positive work at FDA, Gottlieb told CNBC’s Squawk Box that Makary has had “stumbles” and there are concerns about “weak leadership” at CDER and CBER because of the directors he appointed.

“Marty’s a friend,” Gottlieb said. “I think he’s done some admirable things in that role, and I think the continued upheaval at that agency is having a detrimental effect.”

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