The Continued Fight to Undo Mensing

Last month, I highlighted the mounting pressure to remedy the inconsistencies and inequities resulting from the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).  In Mensing, the Supreme Court held that generic drug manufacturers cannot be held liable for state law failure-to-warn claims, even where the generic manufacturers know that the warnings are inadequate, because the state law claims are preempted by federal regulations that require generic drug manufacturers to use safety labels identical to those used by their brand name equivalents.[1]  In sharp contrast, the Supreme Court had previously determined that brand name drug manufacturers can be held liable for injuries caused by inadequate warnings because they can independently revise their drug labels (and can therefore comply with both state and federal law).[2]

The push for legislative action to undo the Supreme Court’s decision in Mensing has continued to gain momentum over the last month.  On April 18, 2012, Senator Patrick Leahy and 6 co-sponsors[3] introduced S.2295, the Patient Safety and Generic Labeling Improvement Act, which seeks “[t]o permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand names to do so.”[4]  Specifically, the bill seeks to add the following to the end of Section 505(j) of the Federal Food, Drug, and Cosmetic Act:

(11)(A) Notwithstanding any other provision of this Act, the holder of an approved application under this subsection may change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application under subsection (b).

(B) In the event of a labeling change made under subparagraph (A), the Secretary may order conforming changes to the labeling of the equivalent listed drug and each drug approved under this subsection that corresponds to such listed drug.[5]

Companion legislation was introduced in the House of Representatives by co-sponsors Chris Van Hollen and Bruce Braley.[6]  In short, the legislation enables generic drug manufacturers to initiate revisions to their labels when they become aware of new safety issues (rather than waiting for the brand name manufacturers to make such revisions), thereby ensuring that safety risks are adequately disclosed and that generic drug manufacturers can be held responsible for inadequate warnings.  Public Citizen applauded the legislation as a way to “fill the regulatory gap in generic drug safety.”[7]

And recently, 41 state attorneys general wrote to Senator Leahy and Senator Franken in support of the Patient Safety and Generic Labeling Improvement Act.[8]  The letter from the National Association of Attorneys General highlighted the “arbitrary and unfair results” of Mensing, noting that the decision “denies consumers of generic drugs the protection of state law provided to consumers of brand-name drugs,” and urged Congress to amend federal law to restore these protections for generic drug consumers.[9]

Both the Senate and House bills have been referred to committee for further action.  Although the fate of these legislative efforts is uncertain—particularly in a highly-charged election year—the growing attention to the inequities brought about by Mensing gives one hope that Congress (or the FDA itself) will ultimately act to protect consumers of generic drugs.