It was noted all the alerts that went around yesterday, such as this one, but since we’ve been following the litigation intensively, here, here, here, and here, we thought we’d note it here for our readers. Unfortunately, as part of Allergan’s Botox settlement yesterday with the federal government, the company was forced to drop its First Amendment-based suit against the FDA’s restrictions on truthful promotion of off-label use. As Allergan’s press release states:
To resolve the criminal and civil investigation, Allergan was required by the Government to dismiss Allergan’s First Amendment lawsuit pending in Washington, D.C., in which Allergan sought a ruling that it could proactively share truthful scientific and medical information with the medical community to assist physicians in evaluating the risks and benefits if they choose to use BOTOX® off‐label to treat certain forms of spasticity. Allergan is disappointed that the court was not afforded an opportunity to hear and rule on these important First Amendment issues, as Allergan believes that physicians, patients, manufacturers, payers, and ultimately the quality of evidence‐based medicine itself would have benefited from a ruling clarifying the law.
We’re disappointed too. But we continue to believe that this First Amendment issue is eventually going to get litigated, and when it does, we think the FDA will lose.