Abstract

This Note traces the subtle changes in the underlying purposes of the Orphan Drug Act, and evaluates those purposes from the perspectives of medical ethics and legal jurisprudence. Part I begins with the history of the Orphan Drug Act discussed issue by issue, to elucidate the subtle changes in the purpose of the Orphan Drug Act through its history. Part II explores the moral and ethical issues presented by the Orphan Drug Act to identify eleven guiding principles from medical ethics and legal jurisprudence. Lastly, Part III applies these guiding principles to the most common proposed amendments to the Orphan Drug Act. Ultimately, through a holistic understanding of the guiding principles which inform the Orphan Drug Act from medical and legal perspectives, amendments will no longer be viewed as patches to fix the “problem drugs” gaining national attention, but as opportunities to strengthen the policy goals underlying the Orphan Drug Act.

Keywords

The Orphan Drug Act, Medical Ethics, Legal Jurisprudence, reaction-based legislation, orphan drugs, personalized medicine, healthcare, pharmaceutical industry, pharma, FDA, United States Food and Drug Administration, Pharmaceutical Companies, problem drugs, policy