Off-label marketing gets free speech protection

January 4, 2013

A recent court ruling allows pharmaceutical representatives to tell doctors about appropriate off-label uses of medications without risking a penalty from federal authorities.

 

New York - A recent court ruling allows pharmaceutical representatives to tell doctors about appropriate off-label uses of medications without risking a penalty from federal authorities.

The Second U.S. Circuit Court of Appeals ruled Dec. 3 that preventing drug manufacturers from promoting truthful statements about off-label medication uses is a violation of the First Amendment, American Medical News reports.

The case involved Alfred Caronia, a former drug representative of Orphan Medical, who had been convicted of illegally marketing the narcolepsy drug Xyrem (sodium oxybate, Jazz Pharmaceuticals) for uses not described in the product’s labeling. In a recorded conversation Mr. Caronia had with a physician, he allegedly said Xyrem could be used for other conditions, such as restless leg syndrome and Parkinson’s disease.

In the case, Mr. Caronia argued the off-label promotion was constitutionally protected free speech, ABC News reports. The appeals court noted that Mr. Caronia had not conspired to put false or deficient labeling on the medication.

If the decision is upheld, it will be more difficult for the Justice Department to bring claims against drug manufacturers for off-label drug promotion, ABC News reports.