FDA in Crisis: V. Prasad, Scandals & the Collapse of Vaccine Regulation

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Nov 17, 2025

Dive into the turmoil at the FDA as leaders and scientists revolt against mismanagement. Explore the fallout from a controversial gene therapy rejection and the alarming proposal to restrict COVID vaccine access for young men. Uncover the political pressures influencing vaccine policies and the unsettling mass resignations within the agency. The hosts reveal a gripping narrative of internal chaos that could reshape public trust in medical regulation and highlight the urgent call to action for political intervention.

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INSIGHT

CBER In Turmoil Under Current Leadership

STAT reporting reveals mass resignations and fear inside FDA's CBER under Vinay Prasad's leadership.
Staff cite mistrust, opaque management, and blocked transfers as drivers of the exodus.

ANECDOTE

Personal Encounter With Huntington's Suffering

Jonathan describes caring for a woman with Huntington's disease who deteriorated over years in a hospital ward.
He uses this to illustrate how devastating the disease is and the importance of potential therapies.

INSIGHT

Promising But Complex Huntington's Gene Therapy

AMT-130 gene therapy delivered by neurosurgery showed major slowing of Huntington's progression in a small open-label cohort.
The procedure is complex: an 18-hour brain infusion guided by MRI into targeted regions.

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This episode dives deep into the escalating chaos inside the FDA as leaders, scientists, and biotech insiders publicly revolt against the agency's current direction. Hosts Jonathan and Wendy break down the explosive STAT News investigations revealing mass resignations, internal fear, political interference, and allegations of mismanagement under V. Prasad's leadership.

The episode unpacks the controversial rejection of a promising Huntington's disease gene therapy, accusations of shifting scientific standards, and the quiet but aggressive attempt by FDA officials — including Tracy Beth Høeg — to restrict access to COVID vaccines for young men. From vaccine policy upheavals to political pressure from the RFK Jr. administration, this conversation exposes the "soap opera" unraveling inside the nation's most important medical regulatory body — and what the turmoil could mean for patients, public trust, and the future of science in America.

Connect with us further on https://sciencebasedmedicine.org/author/jonathanhoward/ The Fine Print

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