Paying for Unapproved Medical Products

34 Pages Posted: 16 Oct 2020

See all articles by Kelly McBride Folkers

Kelly McBride Folkers

NYU Grossman School of Medicine - Division of Medical Ethics

Alison Bateman-House

NYU Grossman School of Medicine - Division of Medical Ethics

Christopher T. Robertson

Boston University; University of Arizona - James E. Rogers College of Law; Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Date Written: October 1, 2020

Abstract

This symposium article examines the use of investigational (un-approved) medical products in the United States, with particular focus on who pays for this use. We examine the various forms of preapproval access (“PAA”) to experimental medical products available in the United States—clinical trials and non-trial preapproval access via the Expanded Access (“EA”) and Right to Try (“RTT”) pathways. For each, this paper analyzes which entity—individual, insurer, sponsor, or other—bears the cost and what limitations or caps, if any, exist on these costs. This paper considers various proposed novel payment mechanisms that may permit more equitable use of investigational medical products.

Part I outlines payment-related disparities in access in-grained in the current United States healthcare system. Part II fo-cuses on access in the context of clinical trials, which most payers have begun to cover, but where remaining uncovered expenses can disincentivize participation in clinical trials, even among those highly motivated to enroll. Part III discusses non-trial preapproval access pathways, specifically Expanded Access and Right to Try, where coverage is scant. Part IV briefly deals with investigational products (such as stem cell treatments) that are available via unregulated or underregulated direct-to-consumer sales. Part V then re-\views the ethical considerations inherent in paying for investigational medical products.

Keywords: new drugs, expanded access, compassionate use, preapproval access, right to try, reimbursement, crowdsourcing

JEL Classification: l13

Suggested Citation

McBride Folkers, Kelly and Bateman-House, Alison and Robertson, Christopher T., Paying for Unapproved Medical Products (October 1, 2020). Wake Forest Law Review, Vol. 11, No. 1, 2020, Boston Univ. School of Law, Public Law Research Paper No. 20-33, Available at SSRN: https://ssrn.com/abstract=3710943

Kelly McBride Folkers

NYU Grossman School of Medicine - Division of Medical Ethics ( email )

United States

Alison Bateman-House

NYU Grossman School of Medicine - Division of Medical Ethics ( email )

United States

Christopher T. Robertson (Contact Author)

Boston University ( email )

765 Commonwealth Avenue
Boston, MA 02215
United States
6179100649 (Phone)
02215 (Fax)

University of Arizona - James E. Rogers College of Law ( email )

P.O. Box 210176
Tucson, AZ 85721-0176
United States

HOME PAGE: http://www.law.arizona.edu/faculty/getprofile.cfm?facultyid=714

Harvard University - Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics ( email )

23 Everett Street
Cambridge, MA 02155
United States

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