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    Research Letter
    Health Policy
    July 24, 2020

    Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015

    Author Affiliations
    • 1Schulich School of Law, Dalhousie University, Halifax, Nova Scotia, Canada
    • 2New York University School of Medicine, New York, New York
    • 3Department of Environmental Health Sciences, Yale School of Public Health, New Haven, Connecticut
    • 4Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
    • 5Health Law Institute, Schulich School of Law, Dalhousie University, Halifax, Nova Scotia, Canada
    • 6Department of Pharmacology, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
    JAMA Netw Open. 2020;3(7):e209498. doi:10.1001/jamanetworkopen.2020.9498

    Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval of novel therapeutic agents.