Wednesday, October 29, 2008
Waxman Pounces as Wyeth v. Levine Argument Looms
Not that Democrats and trial lawyers would ever work in unison or anything, but Rep. Henry Waxman, D-Calif., issued a report today detailing how Food and Drug Administration career staff objected to a policy change that could affect the ability of plaintiffs to file drug liability suits in state court.
Under the new rules, the FDA maintains that federal labeling laws preempt any state liability laws.
The publication of the report comes just days before the Supreme Court hears arguments in a key case on that very issue, Wyeth v. Levine.
In the report, prepared by the House Oversight and Government Reform Committee that Waxman chairs, his staff argue that regulatory changes in recent years were "made by FDA over the objections of key career officials."
According to agency documents, "high-ranking career officials repeatedly warned that the central factual justifications for the agency's new positions were false," the report states. "They also expressed concern that the changes in the labeling rules would harm patients by significantly delaying the addition of important safety information to drug labels."
It remains to be seen if Chief Justice John G. Roberts, Jr. and his colleagues - who have endorsed an expansion of federal preemption of state law in recent years - pay much attention.