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REMS Preemption

By James M. Beck and Mark Herrmann

We're so sad: Now that Riegel v. Medtronic and Wyeth v. Levine have been decided, we can no longer bill ourselves as "all preemption, all the time!"

We're forced to write about other stuff.

Not so fast!

One of us was giving a talk a few weeks ago, and an audience member posed a good question: How does the new Risk Evaluation and Mitigation Strategy (or "REMS") provision, added by the Food and Drug Administration Amendments Act of 2007, affect preemption?

The answer, of course, is that only time will tell, because there aren't yet any cases involving drugs that went through the REMS process. But REMS does give defendants a chance to assert a preemption defense.

The FDAAA of 2007 adds a new section, 21 U.S.C. Sec. 355-1, captioned "Risk Evaluation and Mitigation Strategies." For previously approved drugs, the FDA may require a REMS if the FDA becomes aware of new safety information and decides that a REMS "is needed to ensure that the benefit of the drug outweigh the risks." Sec. 355-1(a)(2)(A). Other drugs will be "grandfathered" into having a REMS. (The FDA published a list of 15 such grandfathered drugs in March 2008.)

Once the FDA notifies a manufacturer of the need for a REMS, the manufacturer must submit one. The REMS may include medication guides, patient package inserts, and communications plans (such as letters to health care providers) to mitigate the risk associated with the drug. Sec. 355-1(e)(2)-(3). The FDA will review and approve the REMS, and the manufacturer will effect it. The FDA will then assess the REMS periodically.

What does that have to do with preemption?

Potentially everything.

If the FDA identifies a drug risk, evaluates the drug to be sure that the benefits of the drug outweigh its risks, and works with the manufacturer to provide FDA-approved warnings that give proper notice of the risk, then the FDA has focused squarely on the risk in question.

That administrative record, showing that the FDA considered and acted on a specific risk, may establish preemption under the new framework established by Wyeth v. Levine.

As more drugs go through the REMS process, we'll surely see the preemption defense raised in this context.

We can hardly wait.

Full post as published by Drug and Device Law on April 28, 2009 (boomark / email).