Date of Award
Bachelor of Arts
Professor Adam Grossberg
After describing the intellectual property and regulatory environment for orphan drugs in the United States, this thesis compares the investment decisions in the orphan drug market with the larger pharmaceutical industry. A series of case studies trace the development paths of different orphan products using information collected through the Food and Drug Administration (FDA) Approved Drug Product and Orphan Drug Product Designation Databases. In addition to this analysis, difference-in-differences estimates calculated using annual revenues compare the relative success of different orphan products under the current incentive system. This study finds that partial orphan drugs are associated with larger revenue growth. Lastly, this study proposes several policy prescriptions as alternatives to the current legislation.
Smith, Sara H D, "Orphan Drug Development: Incentives Under the Orphan Drug Act". Senior Theses, Trinity College, Hartford, CT 2015.
Trinity College Digital Repository, https://digitalrepository.trincoll.edu/theses/486
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