Wednesday, March 10, 2010

Might The First Amendment Become Moot?

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.


bmartinmd said...

The latest FDA approval applies to adults with spasticity. Botox is still unapproved for use in children with spasticity, but the FDA wants Allergan (and other makers of the toxin) to disseminate safety information regarding use of the product in that situation also. So the FDA could only argue partial "mootness," on the basis of its latest approval.

Edward M. "Ted" McClure said...

“[T]hese considerations ought not to be, as they might be, defeated, by shortterms [sic] orders, capable of repetition, yet evading review, and at one time the government, and at another time the carriers, have their rights determined by the Commission without a chance of redress.” Southern Pacific Terminal Co. v. Interstate Commerce Commission, 219 U.S. 498 at 515 (1911) (emphasis added).