Jump to ContentJump to Main Navigation
Freedom to HarmThe Lasting Legacy of the Laissez Faire Revival$
Users without a subscription are not able to see the full content.

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

Show Summary Details
Page of

PRINTED FROM YALE SCHOLARSHIP ONLINE (www.yale.universitypressscholarship.com). (c) Copyright Yale University Press, 2022. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in YSO for personal use.date: 03 July 2022

Drug and Device Safety

Drug and Device Safety

(p.118) 10 Drug and Device Safety
Freedom to Harm

Thomas O. McGarity

Yale University Press

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

Yale 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.