Controversial Drug Decisions and Regulatory Tension

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.

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