Return of Prasad to CBER Following 10-Day Break in California
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Vinay Prasad, the former director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA), has returned to his role following a brief departure. This decision was made at the request of FDA Commissioner Marty Makary, who has refuted claims that Prasad was pushed out of his position[1][2][3].
Prasad's departure, which occurred on July 29, was preceded by a campaign of criticism against him by conservative personalities, including Laura Loomer, who labelled him a "progressive leftist saboteur" working to undermine President Donald Trump's agenda within the FDA[3]. The reasons behind Prasad's exit remain unclear, but his return is in response to ongoing regulatory challenges, particularly those related to advanced therapies and gene therapy safety issues[3].
One such challenge involves Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy. Three deaths of patients have been reported in relation to this therapy and a trial for the company's investigational limb-girdle muscular dystrophy gene therapy[1]. The FDA had previously compelled Sarepta to halt all shipments of the Duchenne muscular dystrophy gene therapy, marking a turbulent month for the biotech[1].
Prasad's return as director of CBER is seen as a critical move for vaccine and biologics regulation, a sentiment shared by Steven Grossman, policy and regulatory consultant and author of the FDA Matters blog, who expressed guarded optimism about Prasad's return[1].
Heather McKenzie from BioSpace can be contacted for further information via email at heather.mckenzie@our website. Her LinkedIn and Facebook profiles are also available.
The HHS spokesperson stated that Prasad did not want to be a distraction to the great work of the FDA in the Trump administration when confirming his departure[1]. However, the agency's request for Prasad's return suggests a recognition of the importance of his role in navigating the complex and sensitive issues facing the FDA.
[1] BioSpace. (2021, August 1). FDA Commissioner Marty Makary wants Vinay Prasad back at the FDA. BioSpace. https://www.biospace.com/article/fda-commissioner-marty-makary-wants-vinay-prasad-back-at-the-fda/
[2] Endpoints News. (2021, August 1). FDA Commissioner Marty Makary asks Vinay Prasad to return. Endpoints News. https://endpts.com/fda-commissioner-marty-makary-asks-vinay-prasad-to-return
[3] STAT News. (2021, August 1). FDA's Prasad returns as head of CBER after brief departure. STAT News. https://www.statnews.com/2021/08/01/fda-prasad-returns-as-head-of-cber-after-brief-departure/
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