One primary factor that supports the government's position that the First Amendment should not be implicated to contest an action under the False Claims Act (FCA) is “truthful off-label promotional speech.” The FDA may not bring an enforcement action against the manufacturer based on truthful promotional speech alone. The FCA does not prohibit off-label promotion of prescription drugs; rather, it is a remedy for actions that cause the submission of a false claim for payment to the Government. As the FCA does not penalize speech, so the First Amendment is not implicated. Also, off-label promotion that is false or misleading is not entitled to First Amendment protection. As the decision under Caronia, the court held that truthful and non-misleading
