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First Amendment and the Regulation of Pharmaceutical Marketing: Challenges to the Constitutionality of the FDA's Interpretation of the Food, Drug, and Cosmetics Act

NCJ Number
American Criminal Law Review Volume: 49 Issue: 4 Dated: Fall 2012 Pages: 1945-1967
Thea Cohen
Date Published
23 pages
This article addresses efforts by the Food and Drug Administration to regulate marketing by pharmaceutical companies in light of the first amendment.
The Food and Drug Administration (FDA) is currently allowed to regulate the marketing of drugs by pharmaceutical companies, especially when the drug is being marketed for "off-label" purposes, those purposes for which the drug was not originally approved. In the past, the FDA has used the Food, Drug, and Cosmetics Act to expressly prohibit the marketing of drugs for off-label purposes. A ruling by the Second Circuit Court of Appeals in 2012 held that the first amendment prevented the FDA from enforcing its regulations regarding marketing of off-label drug uses. Despite this ruling, the FDA continues to pursue drug manufacturers who promote off-label marketing, even when the marketing is truthful. The author of this article proposes that given the recent rulings of the U.S. Supreme Court in Citizens United v. Federal Election Commission, Thompson v. Western States Medical Center, and Sorrell v. IMS Health Inc., the Court should find that FDA's harsh interpretation of the Food, Drug, and Cosmetics Act (FDCA) as it pertains to marketing of off-label drug usage is unconstitutional and in violation of the First Amendment rights of drug manufacturers. The author examines the FDA's current interpretation of the FDCA and the regulatory scheme that in effect criminalizes the marketing of off-label drug usage. The author next discusses the three case rulings by the Supreme Court which could effectively be used to rule against the FDA in its current scheme to regulate marketing by drug manufacturers. The final section of the article examines the ruling by the Second Circuit Court and how its findings have led to the Federal Government's harsh, and often inconsistent, efforts to criminalize commercial speech.


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