A History of Accelerated Approval: Overcoming the FDA's Bureaucratic Barriers in order to Expedite Desperately Needed Drugs to Critically Ill Patients

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A History of Accelerated Approval: Overcoming the FDA's Bureaucratic Barriers in order to Expedite Desperately Needed Drugs to Critically Ill Patients

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Stahl, Jacob en_US
dc.date.accessioned 2012-06-07T20:29:12Z
dc.date.issued 2005 en_US
dc.identifier.citation A History of Accelerated Approval: Overcoming the FDA's Bureaucratic Barriers in order to Expedite Desperately Needed Drugs to Critically Ill Patients (2005 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852155
dc.description.abstract After the passage in 1962 of the Kefauver-Harris Drug Amendments that mandated that the FDA grant premarket approval for all drugs and added a requirement that drug manufacturers demonstrate the efficacy of their products, the drug approval process dramatically slowed for the next two decades. Only after a combination of sustained criticism by free market advocates and dramatic lobbying efforts and protests by AIDS activists desperate for any drug that might prolong their lives did the FDA relent and implement the accelerated approval program. The FDA can grant accelerated approval for drugs designed to treat life-threatening diseases for which no approved treatments currently exist based upon data from surrogate endpoints (laboratory markers), so long as the endpoints are reasonably believed to predict clinical benefit. This paper examines the history of accelerated approval, and in particular its application to AIDS and cancer drugs. Additionally, it explores critiques of the program from clinical academicians and consumer advocates, and replies from its defenders including the pharmaceutical industry, patient advocates and free market economists. It concludes with recommendations on how to reinvigorate the process in order to expedite the development of cancer drugs. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject drug regulation en
dc.subject expedited en
dc.title A History of Accelerated Approval: Overcoming the FDA's Bureaucratic Barriers in order to Expedite Desperately Needed Drugs to Critically Ill Patients en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T20:29:12Z

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