HOUSE COMMITTEE INVESTIGATING OFF-LABEL PROMOTION

Rep. Henry Waxman (D-Calif.) sent letters to three drugmakers after allegations the companies promoted unapproved uses for some of their products.

Waxman, chairman of the House Committee on Oversight and Government Reform, sent letters to AstraZeneca, Eli Lilly and Cephalon requesting promotional and research information as part of the committee's investigation into pharmaceutical marketing.

In the letter to Eli Lilly, Waxman noted allegations that the company "misled physicians" and promoted off-label uses of its schizophrenia drug Zyprexa. The letter requested details for each clinical trial and study relating to Zyprexa, all documents relating to Zyprexa provided to certain FDA advisory committees and all Zyprexa marketing information.

Eli Lilly denied assertions in two articles in The New York Times that said the company's internal documents show it tried to downplay an increased diabetes risk from Zyprexa and tried to promote off-label use of the drug among elderly patients with mild dementia.

AstraZeneca received a similar letter from Waxman for its schizophrenia drug Seroquel, and Cephalon's letter addressed issues related to its narcotic painkillers Actiq and Fentora. The companies all said they would cooperate with Waxman's requests.

Waxman requested the documents by March 21, the letter said. He also sent similar letters to two medical device companies, Boston Scientific and Johnson & Johnson's Cordis unit, requesting information on their drug-coated stents.

( http://www.fdanews.com/did/6_47/ )