HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Wednesday, May 20, 2009

Professor Gostin on Preemption and Drug Regulation

This week's Journal of the American Medical Association has an interesting article by Professor Gostin on the regulation of pharmaceuticals which touches on the FDA, tort law, and the preemption doctrine.  He writes,

The responsibilities of the FDA are vast, accounting for approximately 25% of all consumer spending, including food, drugs, vaccines, and medical devices. However, it lacks adequate staffing and resources, even as public safety concerns have increased.(cites omitted) At the same time, the agency often does not have the information needed for effective oversight. It is reliant on the manufacturer to find and disclose hazards at the time of approval and postmarketing. Approval decisions, moreover, often consider relatively small numbers in clinical trials, almost ensuring that the full safety and effectiveness profile will emerge only after the drug is marketed to a large population. (cite omitted) Tort litigants, unlike the FDA, have subpoena power and discovery can be a potent way to inform the agency and public of undisclosed risks.

The civil justice system also can compensate patients who are wrongly harmed by drugs and medical devices. Absent tort litigation, patients who sustain grievous injuries would have no recourse.

The "preemption wars" between consumers and industry raise a vital public health question—should FDA approval set a regulatory ceiling for product safety or can states enforce higher safety standards? (cite omitted)  Wyeth will not be the death knell of the preemption doctrine. The Supreme Court strongly hinted that it would preempt tort litigation if the FDA takes an active role and pays close attention to a particular safety risk, and the manufacturer fully discloses all the pertinent facts. If, however, as too often appears to be the case, industry conceals relevant information and the FDA lacks the capacity to do anything about it, the tort system becomes a failsafe, facilitating effective agency oversight and offering a remedy for patients who are wrongly harmed.

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