Drugs

He’s Back: Makary Rehires Prasad as CBER Head

Less than two weeks after abruptly resigning, Vinay Prasad has returned to FDA to continue leading CBER at the request of commissioner Marty Makary and HHS secretary Robert F. Kennedy Jr. Prasad, who had come under attack from right-wing activist and commentator Laura Loomer, former Sen. Rick Santorum (R-PA), and the Wall Street Journal editorial board (see story), decided to resign late last month to avoid being a distraction for the Trump Administration.

“At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” HHS spokesperson Andrew Nixon told The Hill in a statement. “Neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration.”

Reacting to Prasad’s return, Loomer said in a post on X that it was “another egregious personnel decision under the Trump administration.” She said “longtime progressive Marxist Vinay Prasad, who referred to President Trump’s supporters as criminals and compared them to drug addicts after saying he stabbed a Trump voodoo doll to ‘curse Trump’ is apparently back at FDA after @MartyMakary advocated for him. In the coming weeks, I will be ramping up my exposés of officials within HHS and FDA so the American people can see more of the pay-for-play rot themselves and how rabid Trump haters continue to be hired in the Trump administration.”

Many FDA watchers will be closely monitoring Prasad’s involvement in ongoing regulatory decisions, particularly that of Sarepta’s Duchenne muscular dystrophy treatment Elevidys. He became embroiled in the agency’s back-and-forth position on Elevidys (see story) when FDA last month asked the company to pause shipments of the drug and then reversed its position. Prasad had criticized the decision of former CBER director Peter Marks to approve the drug for nearly all patients in 6/2024. Sen. Ron Johnson (R-WI) said he even texted President Trump to be sure he was aware that the muscular dystrophy community was upset with Prasad’s initial decision to pause Elevidys shipments.

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