United States v. Caronia: The increasing strength of commercial free speech and potential new emphasis on classifying off-label promotion as "false and misleading".

Abstract

The authority of the United States Food and Drug Administration (FDA) to prohibit off-label promotion of drug products suffered another serious setback in United States v. Caronia. Viewing a legal system where physicians can prescribe prescription pharmaceuticals for unapproved uses legally in their practice of medicine, the Federal appeals court affirmed the commercial free speech rights of manufacturers to use truthful, non-misleading speech about lawfully marketed products. As a result of this case, and others upon which the decision is based, FDA is likely to challenge manufacturer promotion more carefully, and only if it can demonstrate that claims are not truthful, but are false or misleading, or otherwise deprive the prescriber of adequate directions for use.