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# FDA or Courts Should Rethink Off-Label Rules: Cato
- URL: https://www.fdaweb.com/fda-or-courts-should-rethink-off-label-rules-cato/
- Published: 2021-08-12T12:00:00.000Z
- Updated: 2026-09-14T17:10:27.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5149926

The Cato Institute, a Libertarian think tank, says a case before the U.S. 1st Circuit Court of Appeals is again raising issues involving FDA’s “paradoxical stance” toward off-label use of drugs. A Cato online [post](https://www.cato.org/blog/fda-wont-rethink-rules-label-drug-use-courts-should?ref=fdaweb.com) says that while it is lawful for physicians to prescribe approved drugs for other than the FDA approved use, and such uses are vital in everyday practice, the agency strictly prohibits drug makers from promoting such use, even if the information being presented is truthful, not exaggerated or misleading, and critically important to patient welfare. “This prohibition is in tension with Supreme Court holdings on the First Amendment’s application to commercial speech,” Cato says.

The post quotes the Washington Legal Foundation’s (WLF) summary of *U.S. v. Facteau* in which two company executives were convicted of misdemeanor adulteration and misbranding under the Federal Food, Drug, and Cosmetic Act for distributing a medical device for an off-label use. WLF says that at trial a jury found that no defendant made false or misleading statements, nor had any intent to defraud or mislead, and so acquitted on all charges involving intent. WLF has filed an *amicus* brief urging the 1st Circuit to find FDA’s application of the misbranding and adulteration rules to truthful, non-misleading speech a First Amendment violation under strict or even intermediate scrutiny.

Cato says the district court federal judge who heard the case questioned whether Congress even intended to use the misbranding and adulteration statutes to criminalize truthful statements. “Where a conviction can result in exclusion from healthcare programs, likely a death knell for any company, it is also important for the regulatory and law enforcement regime to clearly spell out what is and is not prohibited conduct,” the judge said.