How Is Generic Preemption Like Fraud On The FDA?


A couple of months ago, we provided our stream-of-consciousness impressions of the Mensing/Demahy generic preemption argument to the Supreme Court. As we mentioned then, we were all set to write an obituary on generic preemption. After all, since Wyeth v. Levine, 555 U.S. 555 (2009), generic preemption had lost in every court of appeals to consider the issue, and the government (the Solicitor General) had weighed in on the anti-preemption side as well.

As we remarked then, the generic side appeared to do much better than expected during the oral argument. Not only were they sympathetically received by the three justices (Roberts, Scalia, Alito) who had dissented in Levine, but two critical swing justices (Kennedy, Breyer), seemed to be of the view - we say "seemed" because oral argument prognostication is only a little better than reading tea leaves - that Mensing fell under the aegis of preemption as recognized in Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001). Here are some excerpts from that post:

Justice Kennedy made a startling statement – that this case may even be "a fortiori" from Buckman. Whoa. Justice Kennedy is another crucial swing preemption vote. If that was really what he thinks, then that sounds like good news indeed for the generics, since he voted against preemption in Levine.


We then get an interesting observation from Justice Breyer that, rather than Levine, the case is more like Buckman, because any supposed duty to tell the FDA something, amounts to a claim that private plaintiffs can enforce that duty, as opposed to the FDA "enforcing their own stuff."


So two key swing justices, Kennedy and Breyer, each made comments during oral argument equating generic preemption, and the “take steps” rationale, with Buckman rather than Levine. That bears watching.

Since then, we've had the opportunity to discuss this aspect of Mensing with a couple of lawyer friends whose opinions on these sorts of issues we respect a lot. They'll have to remain nameless because we don't have permission to identify them, and can't get it on short notice. But the upshot is that they also noticed the same thing and think that there's a good chance, maybe even 50-50, that enough members of the Court might buy the Buckman argument to tip the balance in Mensing.

We thought we'd explain how that can be in a little more coherent fashion, that is more coherently than in our oral argument post. The major way in which, functionally, Mensing is different from Levine is that, to enforce the statutory (Hatch-Waxman amendments to the FDCA) mandate that generic labeling be the "same" as the label carried by the original branded drug that the generics are copying, generic manufacturers are not permitted to change their labels through the "changes being effected" (CBE) process. That was a big deal in the Levine debacle because CBE doesn't require FDA pre-approval.

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