Nothing Generic About It: Promoting Therapeutic Access by Overcoming Regulatory and Legal Barriers to a Robust Generic Medical Device Market

Shapiro, Zachary; Pan, Adam; James, Keturah; Wright, Megan S.; Fins, Joseph

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Nothing Generic About It: Promoting Therapeutic Access by Overcoming Regulatory and Legal Barriers to a Robust Generic Medical Device Market

North Carolina Law Review, Vol. 98, No. 3, 2020

35 Pages Posted: 1 May 2020

See all articles by Zachary Shapiro

Megan S. Wright

Florida State University - College of Law; Pennsylvania State University - Penn State Dickinson Law

Joseph Fins

Weill Cornell Medical College

Date Written: 2020

Abstract

This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the absence of medical devices in clinical practice. We conclude with recommendations to foster more widespread development of generic medical devices.

Keywords: FDA, generic drugs, medical devices, products liability, patentability

Suggested Citation: Suggested Citation

Shapiro, Zachary and Pan, Adam and James, Keturah and Wright, Megan and Fins, Joseph, Nothing Generic About It: Promoting Therapeutic Access by Overcoming Regulatory and Legal Barriers to a Robust Generic Medical Device Market (2020). North Carolina Law Review, Vol. 98, No. 3, 2020, Available at SSRN: https://ssrn.com/abstract=3570245