The New York Times reported on a lawsuit against the FDA by Amarin, the manufacturer of a prescription omega-3 fatty acid derivative. The company wants the right to tell physicians about benefits of its drug which the FDA has not approved.
“If you tell the truth — if you’re not misleading — then the First Amendment protects you when you provide this sort of information,” a lawyer for the company told the Times.
But a representative of Public Citizen said, “The First Amendment right is not an absolute right. It has limits. And it’s always been subject to a balancing test. If this lawsuit were to succeed, it would be devastating for drug safety and undermine the drug approval process.”
Drugmaker Sues F.D.A. Over Right to Discuss Off-Label Uses (New York Times, May 7, 2015)