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The Crime of Being in Charge: Executive Culpability and Collateral Consequences

Katrice Bridges Copeland

in FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0011
Subject:
Law, Medical Law

This chapter argues that pharmaceutical executives, who are charged as responsible corporate officers and receive minor criminal penalties, should not face the harsh civil remedy of exclusion from ... More


Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health

Patrick O’Leary

in FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0012
Subject:
Law, Medical Law

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 ... More


Exclusions in Patent Law as an Indirect Form of Regulation for New Health Technologies in Europe

Amanda Odell‐West

in European Law and New Health Technologies

Published in print:
2013
Published Online:
May 2013
ISBN:
9780199659210
eISBN:
9780191748165
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199659210.003.0007
Subject:
Law, EU Law, Medical Law

This chapter considers the effects of the ‘medical’ and ‘morality’ exclusions in patent law on new health technologies. It begins by outlining the legal framework for patents in Europe and describing ... More


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