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

35 Pages Posted: 1 May 2020

See all articles by Zachary Shapiro

Zachary Shapiro

affiliation not provided to SSRN

Adam Pan

Yale University, Law School, Students

Keturah James

Yale University, Law School, Students

Megan S. Wright

The Pennsylvania State University (University Park) – Penn State 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

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

Zachary Shapiro

affiliation not provided to SSRN

Adam Pan

Yale University, Law School, Students ( email )

127 Wall Street
New Haven, CT 06511
United States

Keturah James

Yale University, Law School, Students ( email )

127 Wall Street
New Haven, CT 06511
United States

Megan Wright (Contact Author)

The Pennsylvania State University (University Park) – Penn State Law ( email )

Lewis Katz Building
University Park, PA 16802
United States

Joseph Fins

Weill Cornell Medical College ( email )

1300 York Avenue
New York, NY 10065
United States

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