The Elusive Silver Bullet: FDA Failures, Rejected New Drug Applications, and the Search for an Obesity Cure

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The Elusive Silver Bullet: FDA Failures, Rejected New Drug Applications, and the Search for an Obesity Cure

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dc.contributor.advisor Peter Hutt en_US
dc.contributor.author Canton, Allison Nina
dc.date.accessioned 2012-05-19T21:31:51Z
dc.date.issued 2011
dc.identifier.citation Allison Nina Canton, The Elusive Silver Bullet: FDA Failures, Rejected New Drug Applications, and the Search for an Obesity Cure (March 2011). en_US
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8789607
dc.description.abstract Over the past forty-five years, America has fallen victim to an obesity epidemic, affecting more than thirty percent of American adults. If the incidence of obesity continues at current rates, an estimated forty-percent of Americans will be obese by 2018. Despite its widespread prevalence, treatment is limited to lifestyle modification, surgery, and pharmacotherapy. With lifestyle modification proven to be largely ineffective, surgical options reserved only for the severely obese, and only one long-term drug on the market, there is a vacuum in obesity treatment options. Moreover, the Food and Drug Administration recently rejected three promising drugs. In this paper, I review the obesity problem facing America and describe the history of anti-obesity pharmaceuticals. After examining the three recently rejected drug applications, I bring to light FDA’s new priorities and offer an alternative framework for thinking about pharmacology to guide anti-obesity drug development and review. 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 The Elusive Silver Bullet: FDA Failures, Rejected New Drug Applications, and the Search for an Obesity Cure en_US
dc.type Paper (for course/seminar/workshop) en_US
dash.depositing.author Canton, Allison Nina
dc.date.available 2012-05-19T21:31:51Z

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