Campus Only Senior Thesis
Bachelor of Arts
Science, Technology and Society
Richard K. Worthington
© 2016 Molly Lin
This thesis explores the effectiveness of the Food and Drug Administration’s implementation of Breakthrough Therapy Designation (BTD), focusing on the low number of approval rates and repercussions of BTD for the development of new drugs for patients suffering serious life threatening illnesses. BTD, as an expedited review process, shows potential for improvement in its guidelines for necessary qualifications for BTD. Cutting costs, through a shortening in development time, and raising profits, through first mover status of new to market drugs, BTD is regarded by pharmaceutical executives as a tool to insure not only return on investment but also the rewards that accompanies a profitable blockbuster drug. Lessons learned from activism from 1980’s HIV/AIDS crisis show how advocates and “activist-experts” can rebalance and refocus more attention on the necessary beneficence for patients. A policy stipulation that insures all members: corporate, regulatory, and patient advocate, sit together at the decision making table will insure a more balanced discussion in regards to drug development.
Lin, Molly, "Clinical Trial and Error: An Assessment of the Food and Drug Administration's Implementation of Breakthrough Therapy Designation" (2016). Scripps Senior Theses. 823.
This thesis is restricted to the Claremont Colleges current faculty, students, and staff.