Are “Fraud on the FDA” Allegations that Arise in the Context of Other Tort Claims Preempted Under Buckman?

February 19, 2008
In Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the Supreme Court held that claims alleging agency fraud, so-called “fraud on the FDA,” were impliedly preempted due to their inherent conflict with the federal regulatory
scheme. This article examines the Court’s decision and considers whether federal law preempts state law to the extent that it permits or requires a fact-finder to speculate as to whether a defendant improperly disclosed information to the federal agency that materially affected the agency’s decision to approve or not withdraw the drug.