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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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Recalibrating Enforcement in the Biomedical Industry

Recalibrating Enforcement in the Biomedical Industry

Deterrence and the Primacy of Protecting the Public Health

(p.162) Chapter Nine Recalibrating Enforcement in the Biomedical Industry
FDA in the Twenty-First Century

Patrick O’Leary

Columbia University Press

The federal government's approach to enforcement in the biomedical industry—emphasizing massive fines and restrictive corporate integrity agreements—has proven ineffective as a deterrent to misconduct. While one way to bridge this deterrence gap is by holding individual corporate officers accountable, it is vital that the agencies doing so use their authority responsibly, consistently, and in accordance with common principles emphasizing, above all, the public-health mission that justifies such authority in the first place.

Keywords:   Park Doctrine, Deterrence, Enforcement, Exclusion, Interagency Coordination, Public Health

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