We’re a little disappointed in you.
Typically, our readers alert us to interesting developments in the field of drug and device law. And you surely know that we’ve been off-label use junkies since we defended the Bone Screw cases back in the ’90s, and we regularly post (here, for example) about how the First Amendment should trump the FDA’s efforts to regulate drug manufacturers’ truthful statements about off-label use.
We’ve come to expect our readers to alert us promptly to important new development in this area.
But you let us down.
You left us to learn only from the print media — this morning’s New York Times — about Allergan’s lawsuit challenging the FDA’s restrictions on off-label communications relating to Botox.
According to the Times, physicians regularly use Botox off-label to treat facial spasms, vocal cord problems, and migraine headaches. Allergan wants to provide information to physicians about patient selection and optimal dosing patterns when Botox is used for those off-label purposes. But the FDA prohibits Allergan from communicating that information, because those communications, says the FDA, would improperly (and illegally) promote off-label uses.
Allergan has now filed a lawsuit challenging, on First Amendment grounds, the FDA’s power to restrict it from communicating truthful information about off-label uses.
And expect more links in the future as we watch this new lawsuit with interest.
ADDENDUM: We knew we could count on you. Not two hours after we published this post, we received an e-mail from a reader giving us the following information:
In case you missed it, there are at least four other recently filed lawsuits raising 1st Amendment issues against FDA.
Three are dietary supplement cases – all filed by the Alliance for Natural Health et al in D.C. in August. See the following cause numbers: 1:09-cv-01470- ESH, 1:09-cv-01546 – RJL, and 1:09-cv-01523 – CKK.In addition, the tobacco case in the W.D. of Kentucky (the Commonwealth Brands case) raises 1st Amendment issues and a “Takings” clause argument.It will be interesting to watch these cases progress. We have 1st Amendment challenges being raised across a number of regulatory structures. I wonder who will be next to file a similar case.That’s more like it, guys. Thanks for the update.