Wyeth v. Levine, 555 U.S. 555 (2009), was decided more than two years ago, now. Even though its anti-preemption rationale hinged on an the Court’s interpretation of an exception in an FDA regulation that was in no way required by the FDCA itself, we are unaware of any move by anyone in the industry, or by the regulatory types aligned our side, to seek amendment of that regulation in such a way that would reverse the result in Levine.

PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), was decided little more than two months ago. Like Levine, its preemption rationale – favoring preemption, this time – hinged on the Court’s interpretation of there not being exception in an FDA regulation that was in no way required by the FDCA itself. Showing none of the reticence (if that’s what it should be called) of the defense side, the other side, through its catspaw, Public Citizen, has filed a Citizen Petition requesting that the FDA alter its treatment of generic drugs so as to reverse the preemption result in Mensing. For all the administrative ins and outs of the petition, we recommend the FDA Law Blog’s discussion here.