Thesis Submission Date
Campus Only Senior Thesis
Bachelor of Arts
Richard K. Worthington
Jon A. Shields
© 2012 Meagan Biwer
Pharmaceuticals have benefitted countless lives. New therapies are being developed every day—many prove effective, but many do not. In order to ensure only safe and effective drugs enter the market, the United States' Food and Drug Administration (FDA) approves each treatment based on data garnered from clinical trials. Clinical trials take time, however, and investigational new drugs (INDs) can demonstrate signs of efficacy long before approval. These cases introduce a fundamental question: should the government limit patient access to a drug that has yet to be proven safe and effective? Or do patients have the right to freedom from governmental intervention in their medical decision-making?
In this paper, the history of IND regulation will be explored, followed by an examination of the freedom to access from constitutional, ethical, and infrastructural perspectives. Changes to the current system will then be proposed.
Biwer, Meagan, "The Case for Expanded Access to Investigational New Drugs" (2012). CMC Senior Theses. Paper 414.