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We see it on the web today that the FDA has just approved Allergan’s Botox for several forms of spasticity.  Hooray!  It’s about time.  This has been an effective and widely used off-label use for quite a while now.
Having been interested observers a decade or so ago during the long-running Washington Legal Foundation litigation involving the First Amendment and off-label use, we remember how the FDA succeeded in mooting that suit when things got too hot for the Agency.  See Washington Legal Foundation v. Henney, 202 F.3d 331, 336-37 (D.C. Cir. 2000).  We can’t help but wonder if the FDA is going to try the same thing in Allergan’s first amendment suit (discussed here, here, here, and here).  The “chilled speech” at issue is Allergan’s ability to convey off-label safety information to physicians about, you guessed it, use of Botox to treat spasticity.  See Allergan Motion, at 14-15.  The FDA argued promised not to enforce certain of its regulations in an unconstitutional fashion to moot WLF.  We are just jaded enough to suspect that, in light of the approval, FDA will similarly try to moot the Allergan suit by conceding that the speech in question is now permissible.
Stay tuned.