FDA Policy/General

Vinay Prasad Tapped as New CBER Director

FDA has appointed University of California, San Francisco professor and vocal FDA-industry critic Vinay Prasad to serve as CBER’s new director, replacing Peter Marks, who abruptly resigned last month rather than support what Marks described as HHS secretary Robert F. Kennedy Jr.’s “misinformation and lies” (see earlier story). “With 500+ peer-reviewed publications and two books, Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER — a significant step forward,” FDA commissioner Marty Makary says in a post on X.

Prasad is a hematologist-oncologist and health researcher known for his critical analyses of medical practices and health policy. During the Covid-19 pandemic, he was an early member of the Urgency of Normal group, which advocated against prolonged quarantines and mask mandates in schools. He has also been a vocal critic of certain public health measures, emphasizing the need for policies grounded in robust evidence.

Prasad obtained his medical degree from the University of Chicago in 2009, followed by a residency in internal medicine at Northwestern University (2012). In 2014, he earned a Master of Public Health degree from Johns Hopkins University. He completed fellowships in oncology at the National Cancer Institute and in hematology at the National Heart, Lung, and Blood Institute in 2015.

Seaport Therapeutics founder and CEO Daphne Zohar says in a X post that Prasad’s appointment is a bit odd because his past positions are in direct contrast to Makary’s recent statements on many topics. “Hopefully, Makary can still realize his vision for FDA,” she said. In a Tuesday afternoon note, Jefferies analysts wrote that Prasad has been “historically critical of some gene therapy companies and big approvals in [Duchenne Muscular Dystrophy] and gene editing,” adding that this is having a particular impact on Beam Therapeutics and Verve Therapeutics, both of which are developing base editing therapies, according to Biospace.

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