Allergan’s First Amendment Case: REMS vs. Off-Label Promotion – and DTC

Allergan filed suit against the Food & Drug Administration on Oct. 1, challenging the prohibition of off-label promotion of prescription drugs in the context of a new Risk Evaluation & Mitigation Strategy for the botulinum toxin therapy Botox. At the time, we had just gone to press with a story talking about how REMS might redefine pharmaceutical marketing.

Our thesis: that REMS offer at least the opportunity for commercial organizations to redefine practices viewed skeptically—things like speaker’s bureaus, scripted sales calls, “seeding studies,” etc.—as regulatory obligations that promote the public health. And that, done properly, both the commercial organization and the public health might well come out ahead. (You can read the article here.)

We’ve had the opportunity to discuss that article now with marketing professionals in several contexts, including industry meetings and one-on-one conversations. It fair to say there has been a range of opinion on our thesis--ranging from "you are completely crazy" to "you are completely crazy but you just might be right.”

Having had time to explore the implications of the Allergan suit, we now think we weren't crazy enough. It turns out that REMS aren't just offering a path to rehabilitate controversial marketing practices to support approved indications, they may in fact open the door for companies to promote unapproved uses without inviting crushing regulatory and civil penalties. That, at least, is Allergan's argument (which we explained in depth in “The Pink Sheet” here).

It is a long shot at best to think that Allergan will pull off a complete victory in the case—long in both the sense that most folks we’ve talked see the odds of victory as slim, and also long in the sense that a complete victory would almost certainly involve litigating all the way up to the Supreme Court.

But regardless of the outcome of the suit, the case is an extremely interesting new wrinkle in the still rapidly evolving field of REMS. (Sorry, there is something about Botox that makes puns irresistible.)

Because the simple truth is that FDA now has the authority to do exactly what Allergan wants—allow, or indeed, require greater communication about off label uses. The suit focuses on the fact that FDA is not allowing as complete communication as Allergan wants—but the fact is that FDA could allow that under the existing law and in some sense “approve” an off-label promotion campaign. We doubt they will for Botox, but we’ll keep our eyes peeled (is that another pun?) for a case where they do.

The Allergan suit highlights another thing marketers should anticipate in the context of a REMS: the re-emergence of commitments by sponsors not to advertise their products to consumers in the context of the new programs.

Early versions of the 2007 law included provisions that would explicitly have allowed FDA to impose a moratorium on DTC in the context of a REMS (and the agency already had done so in at least one “voluntary” risk management program negotiated before the law took effect.) Advertisers worked hard to get that provision stripped from the bill, but they did not get anything written into law that would stop sponsors from negotiating those types of provisions as part of a REMS anyway. (We covered all that here.)

How does that relate to the Allergan lawsuit?

In its court filing, the company lays out the off-label campaign it wants permission to conduct—in essence, the REMS agreement it wishes it could get.

And one of those provisions states: “Allergan does not seek to engage in direct-to-consumer communications about the off-label use of Botox.”

That's another one we'll be watching for: the first REMS that includes some limitations on DTC. And our hunch is it will be an agreement that the sponsor is only too willing to make.