FTC v. Simeon Management Corp.: The First Amendment and the Need for Preliminary Injunctions of Commercial Speech

1977 ◽  
Vol 1977 (2) ◽  
pp. 489
Author(s):  
James A. Willhite
Keyword(s):  
First Amendment ◽  
Commercial Speech

scholarly journals Can Speech by FDA-Regulated Firms Ever Be Noncommercial?

2011 ◽  
Vol 37 (2-3) ◽  
pp. 388-421
Author(s):  
Nathan Cortez
Keyword(s):  
Drug Administration ◽  
First Amendment ◽  
Free Speech ◽  
Regulatory Scheme ◽  
Commercial Speech ◽  
Federal Food ◽  
Regulated Firms ◽  
The Supreme Court ◽  
Regulated Firm ◽  
Free Speech Rights

For over a century, the Food and Drug Administration (FDA or the Agency) and its precursors have regulated what companies say about their products. The FDA itself notes that the regulatory scheme imposed by the Federal Food, Drug, and Cosmetic Act “depends on the use of words” and that its requirements can “explicitly limit speech.” For seventy years, the FDA had little reason to worry about First Amendment constraints. But since 1976, when the Supreme Court reversed its longstanding position that the First Amendment does not protect commercial speech, the Agency has had to confront–perhaps more than any other federal agency–the free speech rights of regulated firms.But how far do those rights extend, and what room do they leave for regulators like the FDA? The answer largely depends on another question: Is the speech commercial or noncommercial? The distinction is paramount. If speech by a regulated firm is commercial, then the FDA can ensure that it is not false or misleading; the Agency can require or compel certain speech; it can impose prior restraints; and it can even limit truthful speech, all within certain parameters.

scholarly journals The Indirect Consequences of Expanded Off-Label Promotion

2018 ◽  
Author(s):  
Patricia Zettler
Keyword(s):  
Decision Making ◽  
First Amendment ◽  
Prescription Drugs ◽  
Off Label ◽  
Commercial Speech ◽  
High Profile ◽  
Federal Food ◽  
Legal Challenges ◽  
Drug Promotion ◽  
The U.S

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as suggested in the dissenting opinion in United States v. Caronia, a high-profile 2012 case regarding off-label promotion—protections for off-label promotion might affect the FDA’s decision-making in areas other than drug promotion, and analyzes precisely what those effects could be in light of the FDA’s current statutory authority.Citation: Patricia J. Zettler, The Indirect Consequences of Expanded Off-Label Promotion, 78 Ohio St. L.J. 1053 (2017).

Commercial Speech: Economic Due Process and the First Amendment

1979 ◽  
Vol 65 (1) ◽  
pp. 1 ◽  
Author(s):  
Thomas H. Jackson ◽  
John Calvin Jeffries
Keyword(s):  
First Amendment ◽  
Due Process ◽  
Commercial Speech
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