Govt Responds to Allergan's Free-Speech Complaint

Yesterday, James Beck over at the Drug and Device Law blog provided an update on Allergan v the United States of America et al—last year's No. 5 story at this-here Pathophilia blog. I completely missed it, but 4 days ago the government responded to Allergan's "free-speech" complaint of last year with its own "45-page whopper" (Beck's words) of a motion to dismiss or for summary judgment.

Plowing through the document, my non-legal mind distills the government's 2 basic counterarguments to Allergan "free-speech" complaint to the following.

1. The argument for dismissal: The case isn't "ripe"—meaning, Allergan hasn't said anything yet to potentially violate the law. Of course, this argument highlights the double bind in which the FDA has put the company. Allergan has been asked by the agency to publish safety information about the off-label use of Botox for spasticity; but Allergan logically fears that if it does so, it will run afoul of federal law that prohibits drug promotion for off-label purposes. Allergan's fear is justified by text in the government's own motion, which reads, "advertisements for prescription drugs may not 'recommend or suggest' the drug for unapproved uses."

But the government allows itself a little wiggle room, by also stating, "It is critical to understand, however, that not all speech or actions by a manufacturer regarding an unapproved use is taken by the FDA to be evidence of intended use." However, I find the government's extended argument confusing: "Absent promotion, the dissemination of safety information relating to an unapproved use would not establish that the use is an intended use, and therefore would not trigger either the new drug approval process or the misbranding provisions of the FDCA [Food, Drug, and Cosmetics Act]."

The crux of the issue seems to be whether safety information regarding the off-label use of a drug, on its face, promotes a drug for that off-label use. The government says not necessarily. (In other words, "Hey, trust us. We won't prosecute you for something we ask you to do...unless we decide you've gone too far."). But again, how can a company know when off-label safety information constitutes illegal promotion before it potentially breaks the law?

2. The argument for summary judgment: Allergan's suit is a "frontal assault" (not a full-frontal assault?) on the 1962 Harris-Kefauver Amendment to the FDCA, which requires that a company prove the efficacy of a prescription drug for a particular indication before it can be promoted and sold in interstate commerce. The government lays out a series of contradictory (at least to me) arguments, while invoking a couple of metaphors from Greek mythology (to Beck's amusement).

Essentially the government claims a) current regulatory laws restricting commercial speech are Constitutional, and 2) if it prevailed, Allergan's complaint would allow the promotion of drugs for unapproved uses, thus placing the public health in jeopardy. Beck parses out the government's arguments in reader-friendly bulleted fashion and provides pointed commentary (like a parsimonious "Wow").

But what gets me (again) are the government's incongruous or ambiguous statements, which (as Beck points out) emphasize the vagueness of regulations that restrict the speech of a drug company—and specifically, 21 § CFR 201.128 regarding intended uses. The government writes stuff like...

The Act and regulations leave ample room for Allergan to disseminate truthful, non-promotional information about dangers associated with unapproved uses of Botox, above and beyond the information that FDA has already directed Allergan to provide. [emphasis added]

Okay, the issue again: How do we distinguish between promotional and nonpromotional information?

Well, try this head-spinner on intended uses:

When a manufacturer engages in speech such as advertising or promotional labeling that expressly or implicitly promotes a particular use, FDA treats such speech as evidence that the use is intended. [emphasis added]

Oy.

Beck's even more impressed with the vagueness of this statement.

In practice, FDA usually does not treat an unapproved use as an intended use solely because the manufacturer knows that the unapproved use is taking place.

Usually. [shudder] 

But all of this legal maneuvering between Allergan and the FDA may be moot (or "moo," as Joey on "Friends" would say*), according to the government's motion. In August 2008, Allergan submitted a supplemental biologics license application (sBLA) for the use of Botox in upper-limb spasticity after stroke—one of the off-label indications at issue. However, in May 2009, the FDA declined to approve the drug for the new indication, citing application deficiencies. Then 4 months later, Allergan resubmitted its sBLA. The "goal date" for the FDA's decision, per the motion, is April Fool's Day.

So is the government saying, "Wait. Give us time to approve Botox for spasticity, and this whole free-speech mess we've created will go away"?

N.B. A motion hearing in Allergan v the United States of America et al (09-cv-1879) is still scheduled for March 2nd, in the US District Court for the District of Columbia.

* Which is just about the only funny thing that was said on "Friends."