U.S. Court Reverses Drug Rep's Conviction
A federal appeals court has recently reversed the conviction of a salesman by stating that the U. S. government can't prosecute pharmaceutical makers and their sales staff for promoting drugs for lawful, unapproved uses.
According to the U. S. Food, Drug and Cosmetic Act, or FDCA, doctors have authority to prescribe drugs for unapproved uses but the rules do not allow the drug makers and their sales representatives to promote such prescriptions.
The news is talking about the case of Mr. Alfred Caronia, a sales representative for Orphan Medical Inc., who was convicted in the year 2008 upon charges of playing conspiracy and illegally introducing a misbranded drug into market. He was caught promoting the narcolepsy medication Xyrem for unapproved uses.
Following which, Mr. Caronia appealed in the court that conviction has violated his First Amendment right of freedom of speech, which has been now well supported (today) by the U. S. Court of Appeals in New York that has ruled out that the government has "clearly prosecuted Caronia for his words". The court has also reversed 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", U. S. Circuit Judge Mr. Denny Chin said in a