ICBioethics Blog 

Free Speech and Pharmaceutical Manufactures: Ramifications for Health Care

Written by: Aimee Zellers

The First Amendment is what gives us our right to free speech, free press, the right to assemble, and freedom of religion. Recently, the U.S. court system has further delineated and expanded the reach of free speech, in particular, by defining “protected speech” so that it curtails many governmental restrictions. This new definition has brought about some interesting ramifications, especially in health care. In December of 2012, a three judge panel overturned the conviction of a pharmaceutical representative, Alfred Caronia. He was marketing a certain prescription drug (Xyrem, it is a central nervous system depressant) for off-label application. This means that he was marketing the drug for lawful uses other than what the drug had been originally approved for by the Food and Drug Administration (FDA). The FDA is responsible for ensure that pharmaceutical products are safe for consumers as well as overseeing the marketing of those products. So, in this case, charges were filed against Caronia based on a provision of the Food, Drug, and Cosmetic Act that banned off-label marketing. This is an important provision because it restricts pharmaceutical companies from misbranding, circumventing the rigorous drug approval process, or spreading false or misleading information. The argument Caronia presented to the court was that this conviction infringed upon his right to free speech and expression. The U.S. Court of Appeals for the Second Circuit held in the case of United States v. Caronia that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug, and Cosmetic Act] for speech promoting the lawful, off-label use of an FDA-approved drug.”  The Second Circuit stated that “any right Caronia had as Xyrem’s sales representative to express as commercial speech the truthful promotion of Xyrem’s off-label uses is not unconstitutionally restricted by the misbranding provisions.” This ruling opens some interesting questions.

Some states have laws prohibiting the practice of off-label marketing. This decision, if it holds, would call many of these laws into question. Of course we have not heard the end of this case and appeals will continue. But what do decisions like this mean for health care if they are upheld? Is off-label use actually a good thing that helps us treat illnesses in new unique ways or does this give pharmaceutical companies too much wiggle-room? What can be said with certainty is that the Caronia case has turned down FDA regulations in favor of free speech and expression. Perhaps the greatest concern is, given this wide net of “protected speech,” whether local, state or the federal government can impose regulations that target types of conduct in a given industry. What other federal regulations might be considered in violation of the First Amendment?


Check out the U.S. v. Caronia case at:

Mitch GennusoComment