We honor Labor today by doing very little labor ourselves. If we had our druthers, today would consist of little more than barbecue and indolence. But some members of the family seize upon every holiday as a cue for shopping. There are sales upon sales. For at least a part of today, we expect to
Wyeth v. Levine, 555 U.S. 555 (2009), was decided more than two years ago, now. Even though its anti-preemption rationale hinged on an the Court’s interpretation of an exception in an FDA regulation that was in no way required by the FDCA itself, we are unaware of any move by anyone in the industry,
Thursday is normally the day for our longer and meatier posts. However, the crush of business at the moment really is a crush. So we’re putting up something today that, frankly, doesn’t require as much work. Yesterday we provided our opinions about the latest First Amendment briefing in the Caronia off-label promotion case. We remarked that we were gratified that the industry itself – instead of just interest groups (kudos to the Washington Legal Foundation for engaging in a fairly lonely battle on this issue for years), criminal defendants, and miscellaneous bloggers like us – appeared to be getting into the game.
Our desire to see more First Amendment challenges to the FDA’s suppression of truthful commercial speech in this area is tempered by a countervailing concern not to see any newcomers screw up the law. Large companies with correspondingly large cases and large legal budgets, we don’t worry about much, but many FDA regulated entities whose free speech rights are being chilled by the threat of FDA enforcement aren’t so big.
So we’ve decided to do our bit to help by collecting the best First Amendment/off-label use litigation references that we know about and offering the here. That’s our toolkit.
First, some cases. For anyone even thinking about an FDA-related First Amendment challenge, the Supreme Court’s decisions in Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), and Thompson v. Western States Medical Center, 535 U.S. 357 (2002), are absolutely required reading. The relevant test, at least up until Sorrell, was stated in Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557, 566 (1980).Continue Reading First Amendment Toolkit