FDA Scrutinizes `Off-Label' Promotions
PLEDGING to exert the "full force of the law," Food and Drug commissioner David Kessler, MD, JD, said he will clamp down on pharmaceutical companies that promote their products for off-label uses, as well as those that promote products that have not received federal approval. Physicians acting as agents for a company in these illegal promotions will also be subject to the law, he said.
Kessler said he "will not hesitate to take strong enforcement actions under the Food, Drug, and Cosmetic Act. These include seizure, injunction, and prosecution."
The commissioner underscored his resolve June 11 before the House Subcommittee on Human Resources and Intergovernmental Relations, which oversees all federal health agencies. The subcommittee, chaired by Rep Ted Weiss (D, NY), has been investigating whether the Food and Drug Administration (FDA) has adequately regulated the promotion of drugs and devices for off-label uses, and whether the agency should be given
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