Drug preemption and the need to reform the FDA consultation process.

I. INTRODUCTION The scope of product liability for prescription drug injuries is a highstakes matter. As the recent Vioxx litigation illustrates, drug manufacturers can face numerous lawsuits when users are injured by risks discovered only after the drug reaches the market.1 The extent to which Food and Drug Administration (FDA) decisions preempt tort liability has emerged as a major issue. The agency itself has issued a policy that favors preemption when a drug manufacturer consults with the agency about a new risk.2 The Supreme Court has found liability preempted for medical devices based on an express preemption provisions3 and is expected to make an important ruling on drug preemption this term in Wyeth v. Levine.* Some believe that the Court will rule in favor of preemption even though there is no express statutory provision for drugs.5 The appropriateness of drug preemption has received extensive attention and divergent assessments in the academic scholarship with a mixture of some support6 and criticism.7 The scholarship has examined how federal courts have accepted the preemption defense to a greater degree than state courts,8 and supported an agency reference model in court cases to identify the agency's position on preemption.9 Other scholars have emphasized the need for a lower level of judicial deference, absent rulemaking, for agency preemption decisions that seek to displace the traditional ability of the states to protect their citizens through the availability of liability suits.10 Another article maintains that industry needs to provide the FDA with "the kinds of information within its control that are the logical predicates for a preemptionworthy federal policy."11 This paper will not directly address the general issues about preemption, but rather will emphasize the importance of the consultations between the agency and a drug sponsor about new risks in deciding on the appropriateness of preemption. The most important and difficult preemption question is the liability for risks that are discovered by use after the drug enters the market. Wyeth concerned a serious risk posed by a particular method of administration of a drug, which was discovered during use.12 The case illustrates the drawbacks of the FDA's informal process for determining the need for revised warnings. One ground for preemption raised by the company was that it had proposed a revision and the response of the agency reviewer was to "[r]etain verbiage in current label," but the reason for the agency's response and the company's proposal was not stated.13 The federal government now maintains in its brief in Wyeth that "if preemption turned on the details of the agency's deliberations," it could devolve into "an intrusive, and potentially inconclusive second-guessing of the agency's decisional process."1* However, the important point is not the agency's internal deliberations, but the need to have an adequate explanation of the basis for the agency's decision at the time it is made if it leads to preemption. This article maintains that reform in the agency's present consultation process is necessary. Change is needed to ensure that drug companies identify the new risk information that has led to a consultation, and that the agency issues an accessible decision containing its reasons for whether a change is needed.15 This will promote better decision making. Further, if the Wyeth decision recognizes a preemptive effect, the need to improve the process in the future will be even more critical. If preemption is to apply to past consultations, the agency decision needs to identify the new risk information and reflect that the agency gave considered attention to the core points. This article also examines the weaknesses of the FDA's new preemption policy with a special focus on its applicability to risks found after a drug is approved. A basic flaw with the agency's present preemption policy is the assertion that it is "squarely and solely" for the FDA to determine whether warnings should be added to the label. …