Executive Summary

In a Jan. 23 letter to FDA, eight leading members of the House and Senate criticize the agency's proposed rule to limit when a manufacturer can revise product labeling without prior FDA approval. "We are concerned that the intent of this proposal is to protect companies in the pharmaceutical and device industry from being held liable for marketing products they know are unsafe," the letter states. The signatories, who include Rep. Henry Waxman, D-Calif., and Sen. Edward Kennedy, D-Mass, request FDA to provide data on labeling revisions. The proposed rule reiterates the agency's position that FDA-approved labeling preempts state tort claims. The issue of preemption is being addressed by the U.S. Supreme Court in several cases, including Wyeth v. Levine...