Landmark US court ruling reverses conviction on off-label drug promotion

The US Court of Appeals for the Second Circuit (based in New York City) on December 3  issued a long-awaited ruling in United States versus Caronia, a case involving off-label promotion of a pharmaceutical product, according to a posting on Hyman, Phelps & McNamara’s FDA Law Blog.

The decision is expected to have wide ramifications for the pharmaceutical industry, which has paid billions of dollars in penalties to the US government in recent years after being accused of marketing blockbuster drugs for off-label uses. These include UK pharma giant GlaxoSmithKline (LSE: GSK), which earlier this year agreed to plead guilty and to pay $3 billion - the largest health care fraud settlement in US history - to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices (The Pharma Letter July 3). Pfizer paid $2.3 billion in fines on similar charges in 2009

In a two to one 82-page decision that involves a vigorous dissent, the Court vacated the criminal conviction in 2008 of Alfred Caronia, a former sales representative for a pharmaceutical company. The sales representative was convicted for promoting the drug Xyrem (sodium oxybate oral solution for cataplexy developed by Orphan Medical which was later acquired by Jazz Pharmaceuticals) for a use that had not been approved by the US Food and Drug Administration.