Whether federal law preempts state-law tort claims where a brand-name drug's manufacturer provides the FDA with all material information in its possession at the time the FDA resolves the manufacturer's label change request, or whether applicants must also provide the FDA with data and information that does not exist or that, under binding regulations, the FDA does not want and that the FDA did not rely upon in reaching its decision

QUESTION PRESENTED Federal law preempts state-law tort claims challenging the adequacy of a brand-name drug’s warnings whenever the drug’s manufacturer “fully informed the FDA of the justifications for the warning [allegedly] required by state law and... the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.” Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1678 (2019). That is precisely what happened here: (A) Petitioner GlaxoSmithKline (“GSK”) asked the FDA to approve new cardiovascular warnings for its diabetes drug Avandia; (B) GSK provided the FDA with all material information in GSK’s possession that justified the change at the time of the FDA’s decision; and (C) the FDA responded by denying GSK’s proposed warning because the evidence did not support it. The Third Circuit held, however, that GSK did not “fully inform[]” the FDA of the justification for its label change—and so claims against GSK are not preempted—for two related reasons. First, it faulted GSK for not providing emerging data that did not exist at the time of the FDA’s rejection. Then, to make matters worse, it concluded that GSK should also have submitted other data that FDA _ regulations affirmatively discourage companies from providing, and which, once provided, had no impact on the FDA’s decision. The result is that the Third Circuit has effectively closed the door to conflict preemption that Merck expressly left open The question presented is: Whether federal law preempts state-law tort ii claims where a brand-name drug’s manufacturer provides the FDA with all material information in its possession at the time the FDA resolves the manufacturer’s label change request, or whether applicants must also provide the FDA with data and information that does not exist or that, under binding regulations, the FDA does not want and that the FDA did not rely upon in reaching its decision.