Court: Off-label Drug Promotion Is Protected Speech

The 2nd US Circuit Court of Appeals in New York voted 2-1 to overturn a pharmaceutical salesman's conviction for off-label drug marketing, citing violations against his free speech rights under the First Amendment. The ruling could threaten FDA rules that prevent the marketing of treatments for uses that aren't specifically approved by the agency. The decision addresses a long-running and costly issue for the industry, which has paid billions of dollars in penalties to the federal government in recent years after being accused of marketing blockbuster drugs for off-label uses.