First Advisor

Dr. Stacy Chamberlin


Dr. Tom Howe


Regis College

Degree Name


Document Type

Thesis - Open Access

Number of Pages

98 pages


This thesis explores the way in which the Orphan Drug Act of 1983, originally instituted in response to a lack of treatments for rare diseases in the United States of America, has failed to achieve its initial objectives in the 40 years since its implementation. In evaluating various successful examples of government subsidization programs designed to intervene in private industry, this thesis composes the criterion required for funding-based legislation which maximize market outcomes while minimizing tax-payer burden. An analysis of the synthetic organic chemistry industry – and a case study into the production of a particular orphan treatment for a rare form of T-cell lymphoma – outlines the ways in which the ODA has resulted in declines in the developments in the field of medicinal chemistry, struggles which are not experienced in areas like the budding work of environmental chemistry. Additionally, a cultural and ethical review of the ODA’s societal impact reveals the detrimental effects on patients due to severe price gouging and lack of innovation in pharmaceutical products, outgrowths of the loopholes pharmaceutical companies utilize to maximize profitability through the legislation. Ultimately, this thesis suggests that 1) “orphan” must be defined more stringently, 2) market exclusivity must be granted on the basis of molecule (not the entire disease), and 3) in the event that a treatment turn profitable, the company receiving funds should be reevaluated for funds mishandling.

Date of Award

Spring 2023

Location (Creation)

Colorado (state); Denver (county); Denver (inhabited place)

Rights Statement

All content in this Collection is owned by and subject to the exclusive control of Regis University and the authors of the materials. It is available only for research purposes and may not be used in violation of copyright laws or for unlawful purposes. The materials may not be downloaded in whole or in part without permission of the copyright holder or as otherwise authorized in the “fair use” standards of the U.S. copyright laws and regulations.