Leahy Bill Would Legislatively Undo the U.S. Supreme Court’s Mensing Decision

March 29, 2012

By Kurt R. Karst –      

Last week, the New York Times ran an editorial calling on Congress to enact legislation to address the U.S. Supreme Court’s June 23, 2011, 5-4 landmark decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011).  In Mensing, the Court ruled that FDA’s regulations preventing generic drug manufacturers from changing their labeling except to mirror the label of the brand-name, Reference Listed Drug (“RLD”) manufacturer (whose drug product is approved under an NDA) preempt state-law failure-to-warn claims against generic drug manufacturers, because generic drug manufacturers are unable to comply with both federal and state duties to warn.  Since the Court issued its decision, scores of court decisions have been issued dismissing litigation against generic drug manufacturers on Mensing grounds (including several decisions on the so-called RLD theory of liability – see our previous posts here, here, and here).  In addition, Public Citizen has petitioned FDA to amend its regulations to permit ANDA sponsors to revise their labeling through the Changes Being Effected (“CBE”) and Prior Approval Supplement (“PAS”) procedures (see our previous post here).  (FDA’s position, which the Court relied on, has been that the CBE and PAS procedures are not available to ANDA sponsors to add or strengthen label warnings.)  Now Congress will enter the fray. 

Earlier this week, Senator Patrick Leahy (D-VT) issued a press release saying that he plans to introduce legislation to legislatively reverse Mensing.  According to Sen. Leahy, Mensing “creates a troubling inconsistency in the law with respect to prescription drugs.”  This is a reference to the U.S. Supreme Court’s March 2009 decision in Wyeth v. Levine, 555 U.S. 555 (2009), in which the Court held that state-law tort actions against a brand-name drug manufacturers for failure to provide an adequate warning label are not preempted. 

FDA Law Blog has obtained a copy of Sen. Leahy’s draft bill, which is titled the “Patient Safety and Generic Labeling Improvement Act.”  The bill would amend the FDC Act to add new section 505(w):

(w) Notwithstanding any other provision of this chapter, the holder of an application approved under subsection (j) may change the ‘Warnings’ section of the labeling of a drug so approved in the same manner as the holder of an approved new drug application under subsection (b), unless the Secretary prescribes by rule another manner.

Legislation of this sort is not new.  Back in 2009, Sen. Ted Kennedy (D-MA) and Representative Frank Pallone, Jr. (D-NJ) introduced the “Medical Device Safety Act of 2009” (S. 540 and H.R. 1346) to legislatively reverse the Supreme Court’s pro-preemption decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  That bill died on the vine.