AstraZeneca Challenges FDA Bill's Effect on Preemption Argument

ORLANDO, Fla. - Seroquel manufacturer AstraZeneca argues in a supplemental brief filed recently that a new law giving the FDA more oversight of drug safety monitoring does nothing to alter the agency's position on federal preemption of state law failure-to-warn claims. In Re: Seroquel Products Liability Litigation, MDL No. 1769 (M.D. Fla.).

According to the brief, which was filed Oct. 17 in the U.S. District Court for the Middle District of Florida's Seroquel MDL, the Food and Drug Administration Amendments Act of 2007 merely establishes a "rule of construction" that does not displace existing rules and responsibilities related to drug …