The Trump Administration disrupted the routine and predictable evaluation process followed by the US Centers for Disease Control and Prevention to develop recommendations for vaccine usage, which could delay access to two new products.
CDC Advisory Committee Postponement Upends Complex Regulatory Choreography
The February meeting of US CDC’s Advisory Committee on Immunization Practices was indefinitely delayed to accommodate public comment, which did not open as scheduled on 3 February.
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FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
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In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
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The disruption of CDC’s Advisory Committee on Immunization Practices meeting schedule adds fuel to concerns about potential alterations of the vaccine schedule raised by former FDA Commissioner Scott Gottlieb.
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The February meeting of US CDC’s Advisory Committee on Immunization Practices was indefinitely delayed to accommodate public comment, which did not open as scheduled on 3 February.
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Pink Sheet editors and special guest Michael McCaughan of Prevision Policy discuss Robert F. Kennedy Jr.’s first act as HHS Secretary, former FDA Commissioner Scott Gottlieb’s suggestion that industry extend the existing user fee agreement rather than negotiate a new one, and President Trump’s policies impacting FDA advisory committee schedules and staffing.
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HHS communications restrictions are keeping the FDA from publicly scheduling expected advisory committee meetings. The lack of upcoming meetings is raising concern about missed user fee dates or lower-quality agency decision-making.