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# Top 2 FDA Cell/Gene Therapies Officials Pushed Out
- URL: https://www.fdaweb.com/top-2-fda-cell-gene-therapies-officials-pushed-out/
- Published: 2025-06-20T12:00:00.000Z
- Updated: 2026-09-14T15:14:44.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159389

CBER Office of Therapeutic Products director **Nicole Verdun** and her deputy **Rachael Anatol**, have been pushed out of the Center and placed on administrative leave in the latest shake-up at FDA. An HHS spokesperson hinted that the move was orchestrated by CBER director **Vinay Prasad**, telling ***FDA Webview*** that “Center directors deserve to be supported by managers that are aligned with aggressive goals to expeditiously advance therapeutics for rare diseases using the gold standard of science.”

The Office of Therapeutic Products (OTP) was created under a 2023 CBER reorganization of the Center’s Office of Tissues and Advanced Therapies and includes six new offices within a super office structure that was intended to address a significant increase in cell and gene therapy submissions, according to the agency. Verdun, who had been at the agency since 2012, was named the director at the time of the reorganization.

In reaction to the shake-up, advocacy group Alliance for Regenerative Medicine says they are “deeply disappointed” to learn about the ouster of the two officials. “Over the past two years, Nicole and Rachael have modernized the FDA’s regulatory approach to cell and gene therapy (CGT), earning the trust and respect of the CGT community and helping to ensure that the FDA was the global leader in this evolving field,” the group says in a [statement](https://alliancerm.org/press-release/statement-on-the-departure-of-otp-director/?ref=fdaweb.com). “With five regulatory decisions pending on CGT products in 2025, and a burgeoning pipeline of nearly 2,000 CGT clinical trials ongoing globally, it is critical that CBER and OTP operate at the highest level of productivity, efficiency, and scientific rigor.”

The personnel action also comes at a time when OTP is likely being scrutinized based on two recent patient deaths ([see story](https://www.fdaweb.com/elevidys-shipping-nixed-after-2nd-liver-failure-death/)) associated with Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys. Earlier this week, Former FDA commissioner **Scott Gottlieb** said he expected the agency to reevaluate the Elevidys approval. Speaking on CNBC’s [*Squawk Box* 6/17](https://youtu.be/1%5Ff6P0yw7Q4?si=YetZWZhPGqRqgGH%5F&ref=fdaweb.com), Gottleib said he believes that Prasad will closely examine the recent events and the approval in general because he has previously written about, and criticized former CBER director **Peter Marks**' role in the therapy’s approval.

Gottlieb pointed out in the interview that Prasad is “unusual” in that he was politically appointed as CBER director. Historically FDA Center directors have been civil service employees. Prasad came from academia. “He’s expressed interest in some of these past approvals, and I’ve heard he's also been taking a look at some of the pending CAR-T approvals," Gottlieb said. “I think what happens if the Center director starts getting involved in these regulatory decisions in sort of an arbitrary way then that creates unpredictability in the development space, and people don’t know where to allocate capital."

In reaction to the FDA officials being removed from their posts, Gottlieb said in an X post that this will be a "significant setback for cell gene therapy... These FDA leaders - with their deep subject matter expertise - knew how to make the pathway for these cell and gene therapies more viable. They have been doing hard work to pave the way for safe and effective advances to reach patients who could benefit from them."