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

In March, the high court dodged a Michigan case that mighthave done the same for drugs, deferring to a newer case involving Wyeth’sPremarin on which it is expected to rule by fall. FDA pre-emption for bothdrugs 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 Bushadministration to go against its own best interests and to support pre-emptionin legal briefs and speeches.

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

Without filing briefs on the side of plaintiffs, the agencyinformally encouraged state-level sanctions against violative firms because itknew its enforcement resources could never be adequate to its vast statutorymandate.

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

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