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    A critical review of methods to evaluate the impact of FDA regulatory actions

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    Authors
    Briesacher, Becky A.
    Soumerai, Stephen B.
    Zhang, Fang
    Toh, Sengwee
    Andrade, Susan E.
    Wagner, Joann L.
    Shoaibi, Azadeh
    Gurwitz, Jerry H.
    UMass Chan Affiliations
    Meyers Primary Care Institute
    Department of Medicine, Division of Geriatric Medicine
    Document Type
    Journal Article
    Publication Date
    2013-09-01
    Keywords
    FDA
    Regulatory actions
    Evaluation methodology
    Pharmacoepidemiology
    Clinical Epidemiology
    Health Policy
    Pharmacy Administration, Policy and Regulation
    Public Health
    
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    Link to Full Text
    http://dx.doi.org/10.1002/pds.3480
    Abstract
    PURPOSE: To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions and identify best practices for future evaluations. METHODS: We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empirical evaluation; the review additionally included FDA-identified literature. We used a modified Delphi method to identify preferred methodologies. We included studies with explicit methods to address threats to validity and identified designs and analytic methods with strong internal validity that have been applied to other policy evaluations. RESULTS: We included 18 studies out of 243 abstracts and papers screened. Overall, analytic rigor in prior evaluations of FDA regulatory actions varied considerably; less than a quarter of studies (22%) included control groups. Only 56% assessed changes in the use of substitute products/services, and 11% examined patient health outcomes. Among studies meeting minimal criteria of rigor, 50% found no impact or weak/modest impacts of FDA actions and 33% detected unintended consequences. Among those studies finding significant intended effects of FDA actions, all cited the importance of intensive communication efforts. There are preferred methods with strong internal validity that have yet to be applied to evaluations of FDA regulatory actions. CONCLUSIONS: Rigorous evaluations of the impact of FDA regulatory actions have been limited and infrequent. Several methods with strong internal validity are available to improve trustworthiness of future evaluations of FDA policies.
    Source
    Briesacher BA, Soumerai SB, Zhang F, Toh S, Andrade SE, Wagner JL, Shoaibi A, Gurwitz JH. A critical review of methods to evaluate the impact of FDA regulatory actions. Pharmacoepidemiol Drug Saf. 2013 Sep;22(9):986-94. doi: 10.1002/pds.3480. Link to article on publisher's site
    DOI
    10.1002/pds.3480
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/30047
    PubMed ID
    23847020
    Related Resources
    Link to Article in PubMed
    ae974a485f413a2113503eed53cd6c53
    10.1002/pds.3480
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