Pfizer subsidiary Warner-Lambert illegally used scientific activities, including continuing medical education and research, to commercially promote gabapentin, so that within five years the drug was being widely used for the off-label treatment of pain and psychiatric conditions—conditions that had not been approved by FDA.
[3] The United States federal government is aggressively pursuing criminal and civil cases against pharmaceutical companies and their employees for promoting off-label uses of prescription drugs.
[4] Between 2003 and 2008, U.S. federal prosecutors and state attorneys general brought more than a dozen cases against drug manufacturers for off-label marketing and won more than $6 billion in criminal and civil settlements.
Some legal observers have suggested that the trend in the Court's decisions may ultimately reduce the ability of FDA to prevent broader dissemination of off-label information about approved drug products.
[7] A three-judge panel of the United States Court of Appeals for the Second Circuit in Manhattan ruled on December 5, 2012, that a drug sales representative who was criminally prosecuted for making off-label promotional statements about Xyrem had suffered a violation of his First Amendment right to freedom of speech.