The Florida Attorney General's investigation into sales and marketing practices for Zyprexa (olanzapine) could extend to other Lilly products, the company said.

Lilly received a subpoena in June from the AG's Medicaid Fraud Control Unit, the company said in an Aug. 3 10-Q filing with the Securities & Exchange Commission.

The subpoena seeks "documents relating to sales of Zyprexa and our marketing and promotional practices" with respect to the atypical antipyschotic, the company said.

The company said it is fully complying with the subpoena request and is preparing and supplying documents to the AG's office.

"It is possible that other Lilly products could become subject to investigation and that the outcome of these matters could include criminal charges, fines, penalties, or other monetary or non-monetary remedies," the 10-Q states.

Lilly said the subpoena is unrelated to the removal of Zyprexa and the bipolar depression therapy Symbyax (olanzapine/fluoxetine) from Florida Medicaid's preferred drug list.

The drugs are being taken off the PDL because the company and state were unable to reach an agreement about supplemental rebates (¹ Also see "Lilly’s Zyprexa Transitioning Off Florida Medicaid Preferred Drug List" - Pink Sheet, 7 July, 2005.).

There also is no indication that the AG's document request is related to the state's lawsuits against several generic companies over "average wholesale price," Lilly said.

Lilly's marketing and promotional practices for Zyprexa are the subject of an investigation by the Philadelphia U.S. Attorney's Office as well.

The federal investigation, which has been underway since at least March 2004, also encompasses marketing and promotions for the antidepressant Prozac (fluoxetine) and Prozac Weekly (² Also see "Lilly Is Latest Target Of Philadelphia U.S. Attorney's Rx Investigation" - Pink Sheet, 25 March, 2004.).

In its 10-Q filing, Lilly noted it is cooperating with the Philadelphia U.S. Attorney's investigation and providing "a broad range of documents and information related to the investigation, including documents relating to communications with physicians and the remuneration of physician consultants and advisers."

"We have implemented and continue to review and enhance a broadly based compliance program that includes comprehensive compliance-related activities designed to ensure that our marketing and promotional practices, physician communications and remuneration of health care professionals comply with promotional laws and regulations," the company said.

The Justice Department's Office of Consumer Litigation has another investigation underway regarding marketing, promotions and physician communications related to Lilly's osteoporosis agent Evista (raloxifene). The company has reserved $36 mil. for a potential settlement of that investigation, although discussions are ongoing.

- Sue Sutter

Zyprexa Marketing Documents Sought By Florida Medicaid Fraud Unit

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