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Deference to the FDA's Preamble
A cursory review of the conflicting decisions being rendered across the country reveals that courts are fairly split over the issue of federal pre-emption of failure-to-warn strict liability claims in pharmaceutical litigation. The FDA directly addressed the issue in the Preamble to the Final Rule ('Preamble') published Jan. 24, 2006.
FDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law … FDA interprets the act to establish both a 'floor' and a 'ceiling,' such that additional disclosures of risk information can expose a manufacturer to liability under the act … State law actions also threaten FDA's statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs … FDA believes that State laws conflict with and stand as an obstacle to achievement of the full objectives and purposes of Federal law. 71 Fed. Reg. 3934-35 (2006).
Since the release of the Preamble, many decisions have turned on the level of deference accorded to FDA's position. To some courts and commentators, this interpretation seems inconsistent with former FDA statements suggesting that state law actions were not pre-empted. Since the Preamble is not part of the promulgated rules, it is an advisory opinion that is not definitively binding, but merely expresses the FDA's interpretation of its regulations. Rather than settling the debate, this statement has added another layer of controversy ' namely, what level of deference the FDA's statement is entitled to.
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