FDA Sends Warning Letter To BW

The US Food and Drug Administration has sent a warning letter to Burroughs Wellcome regarding pre-approval promotion to managed care organizations for its antiepilepsy drug Lamictal (lamotrigine). The agency said that the company was deemed to have violated its promotions rules.

The agency stated that BW's activities represented a highly organized and orchestrated campaign to promote the drug prior to approval. It continued that promotion materials and activities, and activities that claim or represent that an investigational new drug is safe and effective for the purposes for which the drug is under investigation, or that otherwise promote the drug, are violate.

BW's promotional packages consisted of a reprint of an article entitled "Focus on Lamotrigine" from the journal Drugs, a drug information package, a product monograph and a bibliography. The pack was sent to 130 pharmacy directors.