Regenerative Medicine and the Right to Try
forthcoming, Wake Forest Journal of Business and Intellectual Property Law
43 Pages Posted: 25 Aug 2018 Last revised: 29 Aug 2018
Date Written: August 8, 2018
Rapid advances in biotechnology research, the widespread proliferation of optimistic scientific and medical information in the media, and demand for access to investigational treatments via media and social media have combined to create a perfect storm of data, advocacy, and speculation about pharmacological and biological remedies. Regenerative medicine research has become one of the focal points of growing public belief that breakthrough treatments are just around the corner but are being withheld from desperately ill patients by an over-regulatory bureaucracy. At the same time, approval for novel pharmaceutical and biotechnological treatments is being accelerated, albeit at breathtaking cost. Are we in a new era that holds the potential to defeat death? Or, have we moved so far toward relaxing protective regulations that we have begun to enable fraud, exploitation, and injustice toward the sickest among us?
This article addresses the promise and the pitfalls of modern medical progress, by examining the “right to try” movement and its historical and conceptual underpinnings, and then considering whether the right to try has any reasonable application to regenerative medicine interventions. Part I provides a brief historical overview of the FDA’s regulation of medical products — focusing on drugs and biologics — as an attempt to balance protection with the imperative of ensuring reasonable access to those products for patients. This part further examines a range of initiatives, from the FDA and other legislative and regulatory bodies, that have speeded product approval and expanded product availability, thus potentially altering the balance between protection and access. Part II then explores the history of the right to try movement, and the current status of right to try legislation, including consideration of how the sympathetic patient narratives spread on social and public media have garnered widespread political support. Part III critiques the right to try legislation by examining the attendant pressures and potential burdens on manufacturers, consumers, physicians, and society with respect to access, costs, safety, and health care disparities. Part IV then returns to regenerative medicine, further considering its relationship to the right to try movement and our desire to rescue so-called identified lives, as well as potential conflicts that may arise between the right to try legislation, the Affordable Care Act, the 21st Century Cures Act, and the overall goal of protecting the public’s health. This article concludes with reflections on the continuing challenges of balancing protection and access in human research, the right to try, and future policy directions.
Keywords: Regenerative Medicine, Precision Medicine, Right to Try, Expanded Access, FDA, Expedited Approval, Breakthrough Therapy, Compassionate Use, Stem Cells
Suggested Citation: Suggested Citation