Company has free-speech right to make truthful statements about off-label use of drug, judge rules
A federal judge in Manhattan has ruled that a pharmaceutical company has a First Amendment right to make truthful statements about an off-label use of a drug.
U.S. District Judge Paul Engelmayer ruled (PDF) on behalf Amarin Pharma and four doctors who sued after the Food and Drug Administration threatened to bring civil charges if they promoted off-label use of a drug called Vascepa, the New York Times DealBook blog reports.
Engelmayer pointed to a 2012 decision, United States v. Caronia, by the 2nd U.S. Circuit Court of Appeals. That decision overturned the conviction of a sales representative who promoted an unapproved use of a drug to doctors. Engelmayer said the Caronia decision prevents the FDA from taking any enforcement action based on true statements about a drug.
The DealBook story says statements about a drug would not be protected if they are fraudulent. “The dividing line is whether promotional statements are actually truthful, and even if they are, was there sufficient information disclosed so that they were not misleading,” the story says.
