Bush-Driven Preemption Language in FDA Regulations is New, Untested, and Unwelcome by FDA Officials

Mike Ferrara

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The Supreme Court recently heard oral arguments in Wyeth v. Levine, which, while deciding whether or not the drug company Wyeth should award damages to plaintiff Diana Levine for a gangrenous arm caused by improper administration of its drug Phenergan, weighed in on the question of whether FDA approval of a drug implies federal preemption of state tort claims against that drug’s maker.

Coincidentally or not, last week the Committee on Oversight and Government Reform released a timely report which demonstrates that historically, the FDA has not made a point of trying to preempt state law claims, but rather, has traditionally “viewed lawsuits brought by persons injured by a drug as a valuable complement to the agency's regulatory efforts.”

As the Committee notes, it is only over the course of the eight year Bush administration that the FDA has begun to make systematic efforts to rewrite drug labeling regulations that not only make it more difficult for manufacturers to dictate or alter their own drug labels, but pervasively add preemption language. Though such language is now “a cornerstone of drug industry preemption arguments,” it had no place in the FDA during former administrations.

Moreover, it appears that the infiltration of such preemption language into FDA regulations occurred at against the express recommendations of high-ranking FDA officials. Rather, these “career officials repeatedly warned that the central factual justifications for the agency's new positions were false. They also expressed concern that the changes in the labeling rules would harm patients by significantly delaying the addition of important safety information to drug labels.”

I’m glad to see the word getting out. For more on how preemption language has entered other regulatory agencies during the Bush Administration, see our Cherry Hill blog.