No Prosecution for Off-Label Drug Sales?

The use of certain drugs for off-label purposes can be a lucrative business for some pharmaceutical companies. And now a federal appeals court ruled that pharmaceutical companies and their sales staff cannot be prosecuted for promoting unapproved uses.

The use of certain drugs for off-label purposes can be a lucrative business for some pharmaceutical companies. And now a federal appeals court ruled that pharmaceutical companies and their sales staff cannot be prosecuted for promoting off-label uses of drugs.

The court reversed the conviction of a sales representative for Orphan Medical, Inc., for promoting a narcolepsy medication for unapproved uses, according to Reuters.

The salesman appealed his conviction, claiming that it violated his freedom of speech and the U.S. Court of Appeals in New York voted 2-1 to reverse the conviction.

“The government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug. The proscribed conduct for which Caronia was prosecuted was precisely his speech in aid of pharmaceutical marketing.”

Just earlier this year, GlaxoSmithKline had to pay a record $3 billion fine for illegally promoting two drugs for uses they were not approved for. In the first half of 2012, drugmakers paid $6.6 billion in financial penalties to federal and state governments in settlements over alleged fraud and illegal marketing.

Although pharmaceutical companies can’t promoted off-label uses, physicians can, which has led to other issues. For instance, a study in PLoS Medicine in August revealed that a low number of physicians disclose a conflict of interest in journal publications when involved in off-label marketing of pharmaceutical products.