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Annual Review of Clinical Psychology

Volume 10, 2014

Drug Approval and Drug Effectiveness

Abstract

Data on the efficacy and safety of psychiatric medicines should form the foundation of evidence-based treatment practices. The US Food and Drug Administration (FDA) reviews such data in determining whether to approve new treatments, and the published literature serves as a repository for evidence on treatment benefits and harms. We describe the FDA review of clinical trials, examining the underlying logic and legal guidelines. Several FDA reviews provide evidence that the agency requires only minimal efficacy for psychiatric drugs. Further, in some instances, the FDA has relied on secondary rather than primary outcomes and has discounted the findings of negative studies in its review of antidepressant and antipsychotic medications. The published literature provides another lens into the safety and efficacy of treatments. We describe how treatment efficacy is systematically overstated and treatment-related harms are understated in the scientific literature. Suggestions are provided to improve public access to underlying safety and efficacy data and for the FDA to potentially improve its review process.

Keyword(s): antidepressant, antipsychotic, clinical significance, Food and Drug Administration, quality of life
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2014-03-28
2024-04-25
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Drug Approval and Drug Effectiveness
Annual Review of Clinical Psychology 10, 741 (2014); https://doi.org/10.1146/annurev-clinpsy-050212-185533
/content/journals/10.1146/annurev-clinpsy-050212-185533
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