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11 Wake Forest J. L. & Pol'y 85 (2020-2021)
Paying for Unapproved Medical Products

handle is hein.journals/wfjlapo11 and id is 85 raw text is: PAYING FOR UNAPPROVED MEDICAL PRODUCTS KELLY MCBRIDE FOLKERS,t ALISON BATEMAN- HOUSE,tt & CHRISTOPHER ROBERTSONttt This symposium article examines the use of investigational (un- approved) medical products in the United States, with particu- lar focus on who pays for this use. In the United States, the question of who pays for the use of approved medical products for their intended indications is complicated enough, with some ex- penses borne by private payers, some by public payers, some cov- ered as charity care, and some paid out of pocket by patients.1 A separate question is off-label use, in which an approved medical product is used for an unapproved indication.2 In this article, we focus on a narrower issue: what entities in the United States pay for access to unapproved medical products, e.g., investigational drugs, devices, or diagnostics that have not (yet) received Food and Drug Administration (FDA) approval. 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 Ex- panded Access (EA) and Right to Try (RTT) pathways. For each, this paper analyzes which entity-individual, insurer, sponsor, or t Senior Research Associate, Division of Medical Ethics, NYU Grossman School of Medicine. tt Assistant Professor, Division of Medical Ethics, NYU Grossman School of Medicine and co-chair NYU Grossman School of Medicine Working Group on Compassionate Use and Preapproval Access (CUPA). ttt N. Neal Pike Scholar and Professor of Law, Boston University, and affiliate with the NYU Grossman School of Medicine Working Group on Compassionate Use and Pre-Ap- proval Access (CUPA). This work was largely done while at University of Arizona, and with the excellent research assistance of Andrea Sharp and the administrative support of Bert Skye. 1. COMM. ON THE CONSEQUENCES OF UNINSURANCE, INST. OF MED. OF THE NAT'L ACADS., HIDDEN COSTS, VALUES LOST: UNINSURANCE IN AMERICA 38 (2003), http://www. nap.edu/catalog/10719.html. 2. O]f=Label Drug Use, AM. CANCER Soc'Y, https://www.cancer.org/treatment/treat- ments-and-side-effects/treatment-types/off-label-drug-use.html (last revised Mar. 17, 2015). 85

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