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As the Bush administration prepares to eke out its last months in office, there is a sense of urgency that it should leave a judicially backed policy that FDA approval pre-empts state laws on product liability. Failure would give a Democratic administration a good opening to begin undoing the Bush gains, one of which came in February when the Supreme Court established FDA pre-emption of medical device lawsuits.

In March, the high court dodged a Michigan case that might have done the same for drugs, deferring to a newer case involving Wyeth's Premarin on which it is expected to rule by fall. FDA pre-emption for both drugs and devices would be a blow not only to the lucrative, company-devastating trial attorneys and their favorite political party (Democrats) but also to the FDA, which has been directed by the Bush administration to go against its own best interests and to support pre-emption in legal briefs and speeches.

In its Clinton administration days and before, the FDA quietly supported state product liability litigation as adjunctive to its always-meager enforcement efforts.

Without filing briefs on the side of plaintiffs, the agency informally encouraged state-level sanctions against violative firms because it knew its enforcement resources could never be adequate to its vast statutory mandate.

Former commissioner David Kessler, a Republican appointee, and Georgetown law professor David Vladeck recently amplified further in a Georgetown law journal article, pointing out that FDA approval is the beginning, not the end of product safety concerns; approval should not insulate marketers from legal consequences. The FDA's ability to assert consequences is much diminished these days. I suspect none of this will slow down the insulators between now and Inauguration Day.

Dickinson is editor of Dickinson's FDA Webview (fdaweb.com).

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