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Freedom to HarmThe Lasting Legacy of the Laissez Faire Revival$
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Thomas O. McGarity

Print publication date: 2013

Print ISBN-13: 9780300141245

Published to Yale Scholarship Online: October 2013

DOI: 10.12987/yale/9780300141245.001.0001

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PRINTED FROM YALE SCHOLARSHIP ONLINE (www.yale.universitypressscholarship.com). (c) Copyright Yale University Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in YSO for personal use.date: 02 December 2021

Drug and Device Safety

Drug and Device Safety

Chapter:
(p.118) 10 Drug and Device Safety
Source:
Freedom to Harm
Author(s):

Thomas O. McGarity

Publisher:
Yale University Press
DOI:10.12987/yale/9780300141245.003.0011

This chapter explains the drug and device industries, which have always had the freedom to become a diverse and technologically dynamic industry capable of designing and manufacturing a broad array of lifesaving products. The Food and Drug Administration Amendments Act of 2007 (FDAAA) raised user fees for both drug and device manufacturers by modest amounts, and allowed the agency to allocate more of the funds they generated to post-market surveillance of approved drugs and devices. It further empowered the Food and Drug Administration (FDA) to require companies to conduct and complete post-approval clinical studies, and allowed the FDA to impose specific label changes. During the Laissez Faire Revival, however, Congress severely limited the FDA's capacity to perform this vital role by reducing the resources available to its surveillance and enforcement functions, while adding to its responsibilities and demanding that it approve new products and technologies at an impossible pace.

Keywords:   freedom, FDAAA, approved drugs, post-market surveillance, Laissez Faire Revival, lifesaving products

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