Today, the House Oversight Committee released a majority staff report detailing objections made by career Food and Drug Administration employees to the Bush administration's repeated attempts to expand the preemption doctrine in ways that would harm American consumers. The report, released just days before Wyeth v. Levine oral arguments, outlines the dangers this policy poses to public safety and the disturbing efforts by officials within the Bush administration to push its pro-business agenda over the objections of career agency staff.
The report claims that “for over a century, state tort law has provided that Americans injured by a defective product can sue the manufacturer of that product for damages” and that in the case of medical devices or drugs, this policy has “provide[d] an additional layer of protection” for the consumer. But despite the century’s old policy of promoting state tort law as a complement to FDA regulation, high-level FDA officials and the Bush administration have spent the past two years working to eliminate this critical safe-guard.
Noting that “internal agency documents obtained by the Committee show that these regulatory changes were made by FDA over the objections of key career officials,” the report goes on to say that these officials “repeatedly warned that the central factual justifications for the agency’s new positions were false.” These officials cautioned that “changes in the labeling rules would harm patients by significantly delaying the addition of important safety information to drug labels.” Sadly, despite their objections, the FDA and the Bush administration has continued to push this policy.
Congressman Henry Waxman continues to do a great job as Chairman of the House Oversight Committee and deserves a great deal of credit for releasing this report at such a critical time. As the nine justices of the Supreme Court prepare to consider this issue on Monday, we hope they consider the committee's findings. The Bush administration and the Chamber of Commerce may argue that state tort laws only frustrate FDA efforts to ensure drug safety, but 100 years of precedent prove otherwise. To enact federal preemption policy without explicit congressional approval would be the definition of “judicial activism.”
To learn more about this issue, check out our fact sheet “The Supreme Court & Big Business” here.