Jump to ContentJump to Main Navigation
FDA in the Twenty-First CenturyThe Challenges of Regulating Drugs and New Technologies$
Users without a subscription are not able to see the full content.

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

Show Summary Details
Page of

PRINTED FROM COLUMBIA SCHOLARSHIP ONLINE (www.columbia.universitypressscholarship.com). (c) Copyright University of Minnesota Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in CUPSO for personal use.date: 05 August 2021

Recalibrating Enforcement in the Biomedical Industry

Recalibrating Enforcement in the Biomedical Industry

Deterrence and the Primacy of Protecting the Public Health

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

Patrick O’Leary

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231171182.003.0012

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

Columbia Scholarship Online requires a subscription or purchase to access the full text of books within the service. Public users can however freely search the site and view the abstracts and keywords for each book and chapter.

Please, subscribe or login to access full text content.

If you think you should have access to this title, please contact your librarian.

To troubleshoot, please check our FAQs, and if you can't find the answer there, please contact us .