Investigation Continues into Whether FDA Regulation Should Bar Liability Claims

Following a May 14, 2008, hearing, Chairman Waxman wrote to the FDA to request documents related to the agency’s recent reversal of its long-standing position on preemption of state product liability lawsuits relating to FDA-approved drugs and medical devices.

Under previous administrations, FDA’s considered such lawsuits a valuable complement to the agency’s regulation of drugs and devices and an important additional layer of consumer protection. Yet, under the Bush Administration, FDA has taken the opposite view, according to testimony by an FDA official at the hearing.