Combating Depression: A History and Analysis of FDA Regulation of Selective Serotonin Reuptake Inhibitors
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CitationCombating Depression: A History and Analysis of FDA Regulation of Selective Serotonin Reuptake Inhibitors (2004 Third Year Paper)
AbstractThis paper explores historical and current regulation by the Food and Drug Administration (FDA) of the most widely-used class of antidepressant drugs, selective serotonin reuptake inhibitors (SSRIs). To begin, I discuss the evolution of societal understanding of depression, and I highlight the pharmaceutical industryâ€™s role in shaping the public perception of the condition. Next, I describe the major classes of antidepressants, focusing on SSRIs and their promise of relief for depressed individuals, as well as their economic benefits to their manufacturers. Then I explore and analyze several interesting challenges posed by SSRIs and other psychotropic medications for the new drug application (NDA) process. Subsequent sections chronicle and critique two noteworthy FDA advisory committee hearings on the potential connection between SSRIs and suicidal and other violent tendencies in patients who take the drugs. Throughout the paper, I attempt to show that the agency strives admirably to fulfill its regulatory mandates that only safe and effective drugs reach the American consumer, and that prescribers and patients are aware of known risks. FDA considers varied and passionate viewpoints on the subject of SSRIs, and although it cannot ever entirely satisfy all interested parties, the agency seems to have recently struck an appropriate balance between widespread access to these drugs and warnings about their potential harms.
Citable link to this pagehttp://nrs.harvard.edu/urn-3:HUL.InstRepos:8846785
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