Abstract

http://ssrn.com/abstract=1793338
 
 

Footnotes (174)



 


 



Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection


Coleen Klasmeier


Sidley Austin LLP

Martin H. Redish


Northwestern University - School of Law

March 23, 2011

American Journal of Law and Medicine, Volume 37, Numbers 2&3, 2011

Abstract:     
When the Food and Drug Administration (FDA) authorizes the marketing of a new drug or medical device, the license reflects the FDA’s review of data and information relating to uses specified by the manufacturer and set forth in agency-approved labeling. Authorized products are often used “off-label,” i.e., for purposes other than those for which they are labeled. However, such uses are legal. Indeed, “off-label” use can be standard medical practice. Despite this undisputed fact, in most instances the FDA prohibits manufacturers from promoting such off-label uses, even to members of the medical profession. In short, the FDA prohibits the speech, even though the activity promoted is perfectly legal and the speech is neither false nor misleading.

In this article, we seek to accomplish two goals: (1) to explore the political and administrative dynamics underlying the evolution of the FDA’s policy towards off-label promotion, and (2) to test that policy by reference to both controlling commercial speech jurisprudence and the underlying values of the First Amendment’s guarantee of free expression. We conclude that the FDA’s prohibition of off-label promotion is the product of a complex set of political factors. We further conclude that not only is the FDA’s policy towards manufacturers’ promotion of off-label use unambiguously inconsistent with well established Supreme Court doctrine on commercial speech, it also contravenes core precepts of democratic theory that provide the normative foundation for the constitutional protection of free expression.

Number of Pages in PDF File: 38

Keywords: Food and Drug, Constitutional Law, Free Expression, Commercial Speech, Administrative Law, First Amendment

JEL Classification: K00, K10, K19, K20, K23, K29, K30, K39

Accepted Paper Series


Download This Paper

Date posted: March 28, 2011 ; Last revised: July 28, 2013

Suggested Citation

Klasmeier, Coleen and Redish, Martin H., Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection (March 23, 2011). American Journal of Law and Medicine, Volume 37, Numbers 2&3, 2011. Available at SSRN: http://ssrn.com/abstract=1793338

Contact Information

Coleen Klasmeier
Sidley Austin LLP ( email )
1501 K Street, N.W.
Washington, DC 20005
United States
HOME PAGE: http://www.sidley.com/klasmeier_coleen/
Martin H. Redish (Contact Author)
Northwestern University - School of Law ( email )
375 E. Chicago Ave
Unit 1505
Chicago, IL 60611
United States
Feedback to SSRN


Paper statistics
Abstract Views: 862
Downloads: 149
Download Rank: 114,641
Footnotes:  174

© 2014 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo3 in 0.422 seconds