• The Milbank quarterly · Sep 2019

    Pharmaceutical Drugs of Uncertain Value, Lifecycle Regulation at the US Food and Drug Administration, and Institutional Incumbency.

    • Matthew Herder.
    • Faculties of Medicine and Law, Dalhousie University.
    • Milbank Q. 2019 Sep 1; 97 (3): 820-857.

    AbstractPolicy Points The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use. Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA-as a regulatory institution-encounters in enforcing PMRs. Through a series of interviews with FDA leadership, this article analyzes and situates those challenges in the midst of political threats to the FDA's public health mandate.© 2019 The Authors. The Milbank Quarterly published by Wiley Periodicals, Inc. on behalf of The Milbank Memorial Fund.

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