First Amendment challenges to the FDA’s off-label promotion ban are hardly novel, however case law in this area remains relatively unsettled. Drug makers initially rejoiced with the ruling in Washington Legal Foundation, however the case was later vacated. Case law now appears to be more settled in the wake of Caronia.
First amendment contests are usually brought as either defenses to off-label prosecutions (as in Caronia) or by advocacy groups and drug companies seeking injunctive relief (Washington Legal Foundation). Continue reading