Court Rules to Protect Off-Label Rx Drug Promotion

A recent court overruling may make it harder for the government to monitor how drugs are marketed and sold. Alfred Caronia, a sales representative for Orphan Medical Inc, now part of Jazz Pharmaecuticals Plc., was convicted in 2008 of conspiracy of introducing a misbranded drug into interstate commerce. He promoted "off-label" use of the drug Xyrem (an FDA-approved drug to treat patients with narcolepsy) by recommending it to consumers for muscle disorders, chronic pain and fatigue. The misdemeanor conviction led to 100 hours of community service and a year of probation, but the 2nd U.S. Circuit Court of Appeals in New York found that the sales representative's First Amendment rights had been violated and the ruling was overturned. "In the fields of medicine and public health, where information can save lives, it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off-label usage, are intelligent and well-informed," Circuit Judge Denny Chin wrote for a 2-1 majority; however, off-label promotion that is false or misleading does not get First Amendment protection. Caronia argued that it should not be illegal for drug companies and sales reps to promote FDA-approved drugs for legal, off-label uses, since doctors may do so without penalty. The 2nd Circuit sided with him, citing that the U.S. Supreme Court ruled last year that speech-aided drug marketing is a form of constitutionally protected expression. Circuit Judge Debra Ann Livingston was the lone dissenter, citing a similar 2004 case in which the court found no First Amendment protection. "The majority calls into question the very foundations of our century-old system of drug regulation," Livingston wrote. "I do not believe that the Supreme Court's precedents compel such a result."