FDA Policy/General

Makary Defends CBER’s Prasad After Loomer Attack

FDA commissioner Marty Makary has defended CBER director Vinay Prasad from an online attack by far-right influencer and Trump confidant Laura Loomer in which she called for his removal for being too left-wing. In an interview with Politico, Makary said Prasad does not have a “political bone” in his body.

Loomer criticized what she called Prasad’s lifelong progressive ideology and his past anti-Trump stance. She cited Prasad’s alleged advocacy for liberal policies like single-payer healthcare, student loan forgiveness, open borders, wealth taxes, and affirmative action. Additionally, she alleged that under Prasad’s leadership, FDA has missed multiple user fee deadlines and delayed approvals of gene and cell therapies without transparent justification. She argued that these actions contradict Trump’s mission to accelerate drug approvals and eliminate bureaucratic delays.

“He’s an impeccable scientist,” Makary told Politico. He also dismissed the attacks on Prasad and the agency more broadly as being driven by increased scrutiny of conservatives. “Usually when a Republican nominee or a conservative is in office, then there’s a level of scrutiny that you just don’t see in prior administrations,” he said.

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