Pharmaceuticals Regulation

The end of the FDA?

When Alfred Caronia worked for a drug company, he promoted some drug’s off-label use. The Department of Justice did not take kindly to Caronia’s behavior and sued him for violating the Food, Drug, and Cosmetic Act (FDCA). He was convicted, but appealed the conviction. Caronia argued that this commercial speech is protected by the first amendment. Here is what happened:

Caronia appealed the conviction, arguing that he had been prosecuted for his speech, breaching his First Amendment rights. The government responded that it had merely used his speech as evidence of his intent to misbrand the drug—that is, Caronia’s statements showed he intended the drug to be used for purposes not described on the label.

On December 3, 2012, the Second Circuit Court of Appeals sided with Caronia, overturning his conviction. In a 2-1 split decision, the court found that the prosecutors’ contention that Caronia’s promotional speech constituted misbranding
and amounted to criminalizing speech. Such a restriction on speech, the court noted, would require the government to satisfy a set of rigorous conditions to justify it—a standard that many judges are now applying, even when the restriction concerns “commercial speech” like drug promotion.

The FDA regulates manufacturers sale of drugs and requires the drug’s benefits to outweight its risks for its intended use. As the dissenting judge pointed out, the United States v Caronia decision could be the first step in the judicial dismantling of the US system of drug regulation.



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