Freedom of Speech Upheld In Healthcare
"The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good. " A US Appeals Court ruled that sharing scientific information about off-label uses of prescription drugs is protected by the First Amendment. Note to opponents of off-label information: you will still have plenty of chances to sue, attack, etc., since the Appeals court stated that then1st amendment doesn't protect misleading or deceptive speech. Which means that the trial bar and AGs will still seek damages under The False Claims Act. What should companies do? Generate clear guidelines on the level of evidence that should be used when sharing off-label information. Should a letter to NEJM discussing one doctor's observations about the novel use of medicine be widely shared? Probably not. But should a company be able to share information based on observational or registry research, comparative trials or new mechanisms of action? Yes. Similarly, companies should come up with a clear set of guidelines for talking about and responding about off label uses in social media. And I think it will be critical to develop a legal strategy reflecting this important ruling. For too long critics of the biopharma industry have been able to flood the digital commons with misleading, deceptive and sensationalist claims based on junk science. The appellate court ruling gives companies a bit more freedom to participate in conversations previously dominated by critics and fearmongers. They should use it or they might lose it.