Regenerative Medicine and the Right to Try

48 Pages Posted: 25 Aug 2018 Last revised: 25 Jan 2019

See all articles by Christine Nero Coughlin

Christine Nero Coughlin

Wake Forest University - School of Law

Nancy M.P. King

Wake Forest University - School of Medicine

Melissa McKinney

Wake Forest University - School of Law

Date Written: January 24, 2019

Abstract

Rapid advances in biotechnology research and the demand for access to investigational treatments via media and social media have combined to create a perfect storm. 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. 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, Part II explores the history of the right to try movement, and the current status of right to try legislation, including consideration of how 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

Coughlin, Christine Nero and King, Nancy M.P. and McKinney, Meilssa, Regenerative Medicine and the Right to Try (January 24, 2019). Wake Forest Intellectual Property Law Journal Vol. 18, No. 4. Available at SSRN: https://ssrn.com/abstract=3237889

Christine Nero Coughlin (Contact Author)

Wake Forest University - School of Law ( email )

P.O. Box 7206
Winston-Salem, NC 27109
United States

Nancy M.P. King

Wake Forest University - School of Medicine ( email )

Medical Center Boulevard
Winston-Salem, NC 27157-1063
United States

Meilssa McKinney

Wake Forest University - School of Law ( email )

P.O. Box 7206
Winston-Salem, NC 27109
United States

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