A Heavy Burden: Rethinking the F.D.A.’s Safety Balancing in the Evaluation of Weight Loss Medications

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A Heavy Burden: Rethinking the F.D.A.’s Safety Balancing in the Evaluation of Weight Loss Medications

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dc.contributor.advisor Peter Hutt en_US
dc.contributor.author Kraus, Erica Justine Hemphill
dc.date.accessioned 2012-05-19T21:38:58Z
dc.date.issued 2011
dc.identifier.citation Erica Justine Hemphill Kraus, A Heavy Burden: Rethinking the F.D.A.’s Safety Balancing in the Evaluation of Weight Loss Medications (April 2011). en_US
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8789609
dc.description.abstract The Food and Drug Administration has recently rejected three drugs for the treatment of obesity based on safety concerns, engendering debate about the standards the Agency should use in evaluating weight loss medications. The debate surrounding these pharmaceuticals is related to two features that make their benefit difficult to evaluate, the particular subjectivity of the benefits they provide and their third party effects. These features tend to exacerbate differences between FDA evaluation of benefit and the evaluation of third party stakeholders. Because the FDA’s safety evaluation relies inherently on an evaluation of benefit, these differences may lead to very different analyses of a drug’s safety. While a more quantitative evaluation of drug benefits may help to resolve some of the issues that arise from the subjectivity of the benefits associated with weight loss drugs, it will not be able to eliminate or accurately reflect individual differences. This kind of analysis may clarify FDA decision making and make risk-benefit profiles more concrete for patients, but to account more fully for the individuality of benefit associated with this class of pharmaceuticals, the FDA should use a more relaxed safety standard to allow for a broader range of treatment options for obese patients. In contrast to the subjectivity of their benefits, the third party effects of weight loss drugs should not be a factor in the FDA approval process; rather, these effects should be taken into account through other kinds of policymaking en_US
dash.license LAA
dc.subject human drugs>>prescription drug licensure>>specific drug products en_US
dc.subject.other Food and Drug Law en_US
dc.title A Heavy Burden: Rethinking the F.D.A.’s Safety Balancing in the Evaluation of Weight Loss Medications en_US
dc.type Paper (for course/seminar/workshop) en_US
dash.depositing.author Kraus, Erica Justine Hemphill
dc.date.available 2012-05-19T21:38:58Z

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