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Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection

Aaron S. Kesselheim and Michelle M. Mello

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/9780231171182.003.0014
Subject:
Law, Medical Law

The FDA prevents prescription drug manufacturers from directly promoting their products for uses that the FDA has not validated (“off-label” uses), but in the recent case of United States v. Caronia, ... More


Pharmaceutical Marketing

Stuart O. Schweitzer and Z. John Lu

in Pharmaceutical Economics and Policy: Perspectives, Promises, and Problems

Published in print:
2018
Published Online:
May 2018
ISBN:
9780190623784
eISBN:
9780190623814
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/oso/9780190623784.003.0011
Subject:
Economics and Finance, Financial Economics

The pharmaceutical industry has been heavily criticized for the amount it spends, as well as for the tactics it uses to promote drugs. This chapter begins by providing an overview of pharmaceutical ... More


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