A New Analytic Tool for Assessing the Impact of the US Food and Drug Administration Regulatory Actions

    Basic Details
    Friday, November 4, 2022

    The aim of this work was to develop and test a flexible, scalable tool using interrupted time series (ITS) analysis to assess the impact of Food and Drug Administration (FDA) regulatory actions on drug use. We applied the tool in the Sentinel Distributed Database to assess the impact of FDA's 2010 drug safety communications (DSC) concerning the safety of long-acting beta2-agonists (LABA) in adult asthma patients. We evaluated changes in LABA use by measuring the initiation of LABA alone and concomitant use of LABA and asthma controller medications (ACM) after the DSCs. The tool generated ITS graphs and used segmented regression to estimate baseline slope, level change, slope change, and absolute and relative changes at up to two user-specified time point(s) after the intervention. We tested the tool and compared our results against prior analyses that used similar measures.


    Christine Y. Lu, Laura Hou, Joy Kolonoski, Andrew B. Petrone, Fang Zhang, Catherine Corey, Ting-Ying Huang, Marie C. Bradley

    Corresponding Author

    Christine Y. Lu; Department of Population Medicine, Harvard Medical School and the Harvard Pilgrim Health Care Institute, Boston, MA

    Email: christine_lu@hphci.harvard.edu