By Kurt R. Karst –
Carrying through on his promise to introduce legislation to legislatively overturn the U.S. Supreme Court’s June 23, 2011 landmark decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), Senator Patrick Leahy (D-VT), along with co-sponsor Sens. Al Franken (D-MN), Jeff Bingaman (D-NM), Sheldon Whitehouse (D-RI), Sherrod Brown (D-OH), Christopher Coons (D-DE), and Richard Blumenthal (D-CT), introduced S. 2295, the Patient Safety and Generic Labeling Improvement Act. (See the announcement here.) A companion bill was introduced in the House by Representatives (H.R. 4384) by Reps. Chris Van Hollen (D-MD) and Bruce Braley (D-IA). (See the announcement here.) In Mensing, the Supreme 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.
The version of the Patient Safety and Generic Labeling Improvement Act introduced is different from (i.e., broader than) the draft version circulated several weeks ago, which we reported on here. S. 2295 would amend FDC Act § 505(j) to add the following language to the statute:
(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.
The draft version of the bill merely stated: “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.”
Although there have not been any rumblings about legislation to counter S. 2295 and H.R. 4384, we note that in 2009, well before the Mensing decision was handed down, Sen. John Cornyn (R-TX) filed an amendment to pending legislation that, if enacted, would have preempted tort suits against generic drug manufacturers. Specifically, Sen. Cornyn’s amendment would have amended the law to state:
Notwithstanding any other provision of State or Federal law, a person who manufacturers a generic drug approved under an [ANDA] shall not be liable because the label did not warn against an adverse reaction, unless the [FDA] required a change to the label to provide such warnings and the manufacturer failed to comply with such requirement, or the manufacturer failed to provide to the [FDA] health and safety information otherwise required to be provided under regulations issued by the Secretary for Health and Human Services regarding such drug.
Public Citizen, which has petitioned FDA to amend its regulations to permit ANDA sponsors to revise their labeling through the Changes Being Effected and Prior Approval Supplement procedures, not surprisingly came out in favor of the introduction of the Patient Safety and Generic Labeling Improvement Act. GPhA issued a statement in response to the introduction of the legislation stating, in part, that “[t]he legislation introduced by Senator Leahy would disrupt [confidence in the industry] and unduly burden physicians who would have to be aware of multiple labels for the same product.”