Public Citizen Health Research Director To Keep Banging Drum On Stronger Benefit-Risk Ratios
Robert Steinbrook, the 50-year-old health group's third director, plans to stay true to organization’s long-held mission of holding FDA drug approvals to high standards, pushing for stronger evidence of benefit, more attention to safety, and advisory committee votes.
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Ability to use beta amyloid plaque reduction to support a traditional approval in Alzheimer’s, or for use with other drug classes, needs to be evaluated case-by-case based on the available data, agency says. In the HIV/AIDS space, it took FDA decades to declare a surrogate endpoint validated.
FDA Commissioner Califf and some top deputies are angling for more advisory panels that would influence drug development programs rather than approval decisions. Califf also wants to adjust meeting formats so advisors have more time for in-depth discussions.
Agency has comments from Public Citizen, National Center for Health Research and American Heart Association to consider among 182 submitted on proposed published in June. FDA set a non-binding target date of October to publish “Nonprescription Drug Product With an Additional Condition for Nonprescription Use” final rule.