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New FDA labeling regulations were effective June 30, 2006. Announced January 18, 2006, these regulations, 21 CFR 201, 314 and 601, have the claimed purpose of providing new labeling guidelines for prescription drugs, to make drug labeling easier to read and understand and to include requirements to highlight certain information and to promote minor changes in graphics and content of drug labels.

The real purpose of the Rule is to provide FDA an opportunity to establish federal preemption of state law tort claims involving prescription drugs. In recent years, the FDA has begun to intervene in state law tort cases involving persons injured by prescription drugs, to argue that their claims are barred by federal preemption. In these cases, the FDA has filed amicus briefs supporting the drug companies which is a reversal of the historic position of the FDA on these matters. Despite efforts by the FDA to undermine state law tort claims, courts have consistently rejected the FDA’s arguments of direct or indirect conflict preemption. See Witczak v. Pfizer, 377 F. Supp.2d 726 (D.Minn.2005)

Apparently frustrated by its failure to preclude tort claims by victims injured from defective drugs, FDA has adopted a new approach. At the urging of the drug companies, FDA acted at the eleventh hour to insert language and commentary supporting federal preemption in its new Final Rule approving highlighting and graphic changes in drug labeling.

Tomorrow: FDA’s statement and response regarding Comments 12 and 13

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