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FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
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Holly Fernandez Lynch and I. Glenn Cohen

Print publication date: 2015

Print ISBN-13: 9780231171182

Published to Columbia Scholarship Online: May 2016

DOI: 10.7312/columbia/9780231171182.001.0001

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FDA, Negotiated Rulemaking, and Generics

FDA, Negotiated Rulemaking, and Generics

A Proposal

(p.382) Chapter Twenty FDA, Negotiated Rulemaking, and Generics
FDA in the Twenty-First Century

Marie Boyd

Columbia University Press

Recent U.S. Supreme Court holdings suggest that while the manufacturer of a brand-name drug is always responsible for its label’s content, this is not the case for generic drugs. In addition, these rulings have removed the protections and compensation that state tort law can provide consumers of generic drugs and exposed a gap in the regulation of generic drugs in which no manufacturer is responsible for updating the labeling. This Chapter argues that to remedy these issues, the Food and Drug Administration (FDA) should use negotiated rulemaking to work with drug manufacturers, consumer representatives, healthcare providers, and other interests to create new drug regulations.

Keywords:   Pharmaceuticals, Generics, Hatch-Waxman, Preemption, Labeling, negotiated rulemaking, FDA

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