Biologics

Prasad Defends Vaccine Policy Shift: Report

CBER director Vinay Prasad addressed a 12/4 closed-door investor conference in New York and defended his leadership and attributed criticism to "misleading media narratives," according to a report by STAT News. His appearance comes the day after 12 former FDA commissioners issued an extraordinary public warning, arguing that sweeping internal directives proposed by Prasad would undermine evidence-based vaccine regulation and threaten public health. In a New England Journal of Medicine Perspective, the former officials said a memo circulated last week by Prasad represents a radical break from long-standing scientific standards that guide vaccine development and evaluation.

CBER has faced significant controversy and plummeting morale under Prasad’s leadership. He defended his new regulatory plan that would require vaccine makers to conduct larger and longer studies before updating vaccines, according to STAT. Prasad said this is part of “modernizing” how FDA approves and updates vaccines, not a recklessly broad rollback of protections. Prasad also reportedly pushed back on the notion that FDA under his leadership is micromanaging “every single thing” — a criticism he said he has seen in the media. “I read in the newspaper I’m both micromanaging... and I’m never there,” he said.

His controversial approach to vaccine regulation and internal clashes with other FDA officials have led to turmoil that has worried investors in the biotech sector and other stakeholders. Under Prasad’s leadership, the agency appears to be moving toward stricter and more conservative regulatory practices, which could dramatically reshape the vaccine and biologics landscape.

So far, for manufacturers and drug developers, the message seems clear: expect longer, more rigorous trials — and possibly less flexibility. Regarding public health concerns, critics worry that the changes could slow the rollout of critical vaccines, especially updates tailored for emerging infectious threats.

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