Showdown on preemption

With 29 "friend of the court" briefs in hand at its August deadline, the U.S. Supreme Court is set to hear oral arguments on Nov. 3 in this year's third and most anticipated case pitting FDA's assertion of preemption authority against state tort laws when a patient has allegedly been harmed by an FDA-approved product. The outcome of Wyeth v. Levine will likely hinge on how the justices interpret the fuzzy area of "implied preemption."

FDA believes that drug labeling cannot be amended without the agency's approval unless a manufacturer has new data showing a causal link between the drug and a safety hazard. FDA also believes that allowing manufacturers to change label warnings would disrupt the agency's congressional mandate to balance how the risks and benefits of drugs should be communicated...