Drug Preemption and the Need to Reform FDA Consultation Process

23 Pages Posted: 8 Oct 2008 Last revised: 2 Jun 2013

Date Written: December 5, 2008


The extent to which FDA decisions can preempt tort liability for prescription drugs is a critical issue that the Supreme Court will address this term in Wyeth v. Levine. The agency has issued a Preemption Policy that favors preemption when a drug manufacturer consults with the agency about a risk. Wyeth has unusual factors since the label warned of the risk from the method that led to the injury, and the plaintiff's expert testified that the label should not have allowed the method at all.

The most important and difficult preemption question is the liability for new risks that are found from use after the drug is on the market. This paper will examine the factors that can limit the scope of the Wyeth decision. Instead of having a broad rule recognizing preemption generally, the determination should focus on matters that the agency has specifically addressed based on current and accurate information. Moreover, the consultations between the drug company and the agency about the need for warnings for emerging risks need to be based on means that ensure "fairness and deliberation."

Suggested Citation

Gilhooley, Margaret, Drug Preemption and the Need to Reform FDA Consultation Process (December 5, 2008). American Journal of Law & Medicine, Vol. 34, p. 535, 2008, Available at SSRN: https://ssrn.com/abstract=1280909 or http://dx.doi.org/10.2139/ssrn.1280909

Margaret Gilhooley (Contact Author)

Seton Hall Law School ( email )

One Newark Center
Newark, NJ 07102-5210
United States

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