By James M. Beck, a Senior Life Sciences Policy Analyst with Reed Smith LLP in the firm’s Philadelphia, PA office.

When Wyeth v. Levine, 555 U.S. 555 (2009), rejected both “goals and objectives” and “impossibility” preemption for prescription drugs, it appeared to be a Waterloo moment for these FDA-regulated products’ most powerful defense.  But after a very difficult period, defendants regrouped, focusing on the limits to Levine’s impossibility-preemption rationale.  Levine turned on the availability of an FDA regulatory exception that makes it possible for a manufacturer to strengthen already approved warnings without first submitting the change to the agency:

Among other things, this ‘changes being effected’ (CBE) regulation provides that if a manufacturer is changing a label to ‘add or strengthen a contraindication, warning, precaution, or adverse reaction’ or to ‘add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product,’ it may make the labeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval. 

Id. (quoting 21 C.F.R. § 314.70(c)(6)(iii)(A), (C)).

Since Levine, prescription drug defendants have clawed back a considerable degree of preemption in areas beyond the reach of the FDA’s CBE regulation.  Defendants have also, in certain situations, overcome the hurdles created by Levine’s “clear evidence” standard for determining if the FDA “would not have approved” the warning a plaintiff demands had it been presented to the agency.  Id. at 571.  Several recent decisions establish new beachheads for preemption.