Biologics

HR Complaints Filed Against Prasad: Report

The 11/5 Medpage Investigative Roundup highlights key findings in a STAT report (subscription required) about chaos at CBER under the leadership of Center director Vinay Prasad. The report indicates that several CBER employees have filed human resources complaints about the director’s management style and practices. It says employees told STAT anonymously that Prasad is not a transparent or communicative manager, and his main leadership goal seems to be adding more scrutiny to vaccines.

Workers also fault him for ignoring the chain of command and reaching out to people directly, something so alien to the staff that some of his e-mails have been reported as phishing.

Fired after three months on the job on the recommendation of conservative activist and Trump-whisperer Laura Loomer, who claimed Prasad supported Democrats and liberal ideas, he was brought back two weeks later after FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr., went to bat for him with the White House.

“It’s worse than part one,” an agency official told STAT, “Part one, he was figuring out where he was fitting. He was more cautious. He came back from the firing with a feeling of invincibility…. He came back with an attitude of, ‘I will do whatever I want.’”

In his time at CBER, the article says, Prasad has already pushed out at least seven senior leaders as part of an environment that employees worry threatens the Center’s ability to function.

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