A critical review of methods to evaluate the impact of FDA regulatory actions
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 InstituteDepartment of Medicine, Division of Geriatric Medicine
Document Type
Journal ArticlePublication Date
2013-09-01Keywords
FDARegulatory actions
Evaluation methodology
Pharmacoepidemiology
Clinical Epidemiology
Health Policy
Pharmacy Administration, Policy and Regulation
Public Health
Metadata
Show full item recordAbstract
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 siteDOI
10.1002/pds.3480Permanent Link to this Item
http://hdl.handle.net/20.500.14038/30047PubMed ID
23847020Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1002/pds.3480