US FDA’s Califf Expects Advisory Committee Reform Talk ‘About A Year From Now’
The FDA commissioner said several aspects of the advisory committee system should be considered for updates or adjustment. A revamp effort has predated his return trip to the agency.
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A new study finds the agency only approved a product despite a negative advisory committee vote six times in six years. The overall rate of agreement between the agency and advisory committees has increased since 2015.
Commissioner Robert Califf’s comments offer further context for FDA’s unprecedented decision to reconvene an advisory committee for a second review of Amylyx’ AMX0035 for ALS.
Outlining what changes he wants to see at the agency before he leaves, Califf also worries congressional inaction on the user fee reauthorization could affect hiring efforts.