Should Preemption Apply in a Pharmaceutical Context? An Analysis of the Preemption Debate and What Regulatory Compliance Statutes Contribute to the Discussion

November 1, 2011

Should the Food and Drug Administration (FDA)’s determination that a product is safe negate a private litigant’s cause of action under state law in all circumstances, unless the FDA determines that the manufacturer withheld relevant information regarding the safety of the product? This Note concludes that such federal preemption is proper because the FDA is fully capable of making a determination regarding the adequacy of the information disclosed by a pharmaceutical manufacturer without state interference. Additionally, such interference on the state level hinders the FDA’s objectives and effective functioning. Thus, determinations about the adequacy of the information provided to the FDA should remain in the Agency’s sound discretion and not be questioned at the state level.

October 2008

No. 1