New Challenges to the FDA's Drug-Labeling Policy: Democrats Are Poised to Pounce.

Waxman report, which also touches on the pre-emption matter. The report issued by Representative Waxman’s House Oversight and Invest igations Committee in late October argued that the FDA had recently restricted CBE authority twice—one time as part of the 2006 Physician Labeling Rule and a second time in a CBE rule issued in August 2008. The Waxman report was controversial because it said that top FDA officials in career safety had warned against circumscribing CBE authority, but Bush administration political appointees in the Office of the General Counsel went ahead anyway. Complicating the FDA’s tightening of the CBE rule in 2006 and 2008 was another factor: at the same time, in both rulings, the FDA also included pre-emption language stating that consumers could not sue a drug company for “failure to warn” in state court based on a state law. The Waxman report quoted John Jen kins, MD, Director of the Office of New Drugs (OND), in the Center for Drug Evaluation and Research (CDER), who sent comments to Jane Axelrad, JD, As sociate Director for Policy in CDER. On May 22, 2003, as the pre-emption policy was being developed, Dr. Jenkins wrote: