What If We Win? Off-Label Promotion & Product Liability

Since the nomination of Dr. Scott Gottlieb to head the FDA, we've seen quite a few references to his opposition to the current FDA prohibition against off-label promotion - regardless of the truth of the promotion itself. We don't think we can add a lot to those descriptions of Dr. Gottlieb's views, so we won't try. We will, of course, be very pleased if the FDA ends its unconstitutional ban on truthful off-label promotion before ultimately being forced to by the courts.

We've also read a recent (3/15) Bloomberg piece (here, for those with a subscription) entitled "Off-Label Promotion Could Mean More Drug Company Liability." Although apparently written before the Gottlieb nomination, this article consists largely of the interviews with two avatars of the other side of the "v.": fellow blogger Max Kennerly (who regularly writes intelligent critiques of our posts) and Lou Bogrod, with whom we've tangled before over off-label issues. Needless to say, we disagree with the "more liability" spin they put on any would-be FDA retreat on off-label promotion.

Here's why - and we apologize to all of you who can't read the article we're responding to, but it's behind a paywall, and Michael Bloomberg didn't get to be a billionaire by giving things away that he could charge for (that's what we do).

The first contention is that, once truthful off-label promotion is legal, "drug companies would lose the protection afforded by preemption." We don't think that's grounds for "more liability." First of all, "drug companies" - at least those making innovative branded drugs, don't have much of a preemption defense. The Supreme Court unfortunately took care of that in Wyeth v. Levine, 555 U.S. 555 (2009), limiting preemption to cases of "clear evidence" that the FDA would have rejected the label change in question. There are other possible preemption grounds concerning design defect claims (which we've advocated here), but off-label promotion doesn't involve design. So, while there may be liability issues raised concerning specific instances of off-label promotion, we don't see any basis for calling it "more" liability than already exists for on-label promotion. Most branded drug warnings don't have a preemption defense now.

Indeed, the result could very well be less liability. Even if truthful off-label promotion were to become broadly legal, the off-label use itself remains off-label. The FDA, however, can order a drug's label to contain statements (usually warnings) about an off-label use. 21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of "required by" the FDA). That's important because, as we discussed in more detail here, only the FDA can do this. Drug companies are not allowed to discuss off-label uses in their labels whenever they want. Without the FDA telling them to, that is a form of misbranding.

Should truthful off-label promotion become legal, it may be expected that the FDA would react by ordering more warnings about those uses to appear on drug/device labeling. That's actually good for preemption, in a number of ways.

First, with the FDA picking the language it wants, an order to put "X" in the label about a particular off-label risk is (to our defense-oriented way of thinking) "clear evidence" under Levine that the FDA doesn't want some plaintiff-advocated statement "Y" on that same label. Once the FDA itself is in the business of imposing precise wording, the...