Drugmaker Eli Lilly and Co. said a previously disclosed federal investigation of possible improper marketing of an osteoporosis drug could expand into how Lilly marketed its top-seller, Zyprexa, or other Lilly drugs.
Lilly, one of several drugmakers to be subpoenaed recently by the Department of Justice over marketing practices, received grand jury subpoenas in July 2002 and July 2003 over promotions of the drug Evista to consumers and doctors.
The review began after a competitor complained Lilly was improperly marketing the osteoporosis drug as a breast cancer preventative -- a use for which it did not have Food and Drug Administration approval.
Lilly said in a regulatory filing Tuesday that it has shared information with government investigators and worked to ensure compliance with marketing regulations.
"It is possible that other Lilly products, including Zyprexa, could become subject to investigation," the filing said, noting that government reviews of industry marketing have included some neurological drugs such as Zyprexa.
While the time frame for the investigation and outcome are uncertain, Lilly said the review could lead to criminal charges, fines or civil penalties and could hurt its financial position.
Zyprexa has been prescribed to 12.5 million people since its introduction in 1996 as an alternative to older schizophrenia treatments that tend to have more serious side effects.
The antipsychotic now accounts for about a third of overall sales at Indianapolis-based Lilly, with Zyprexa sales last year reaching $4.3 billion. Zyprexa sales have grown recently despite competitive pressure from newer rivals Geodon and Abilify. Zyprexa also is undergoing a patent challenge.