In a front-page article, the New York Times (1/31, A1, Berenson) reports that "Eli Lilly and federal prosecutors are discussing a settlement of a civil and criminal investigation into the company's marketing of the antipsychotic drug Zyprexa (olanzapine) that could result in Lilly's paying more than $1 billion to federal and state governments." The settlement "would be the largest ever paid by a drug company for breaking the federal laws that govern how drugmakers can promote their medicines." Although "Zyprexa has serious side effects, and is approved only to treat people with schizophrenia and severe bipolar disorder," Lilly documents indicate "that between 2000 and 2003," the drugmaker "encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously been diagnosed only as depressed." Any attempts by "drugmakers to promote their medicines [for] any uses not formally approved by the Food and Drug Administration (FDA)," is illegal.

        According to the Wall Street Journal (1/31, A14, Johnson, Carreyou), last year "a grand jury subpoena...raised the prospect that" Eli Lilly might "be indicted" after "a nearly four-year federal investigation and 30 state probes." A criminal indictment may potentially cost the drugmaker "lucrative government reimbursement and contracts."

        The AP (1/31) adds that "several unidentified people involved in the investigation confirmed the settlement discussions." In an earlier statement, "Lilly said...that it received a grand jury subpoena from the U.S. attorney for the Eastern District of Pennsylvania seeking Zyprexa-related documents." According to Lilly spokeswoman Tarra Ryker, the company is "cooperating with the government in these investigations, and the discussions around those are confidential."

        Bloomberg (1/31, Lopatto) reports that the investigation "centers on marketing and promotional practices related to the pill's sales in the U.S., including communication with doctors, and the way the company paid consulting physicians and other advisers." The case dates back to March 2004, when "the U.S. attorney's office told Lilly it had begun a civil investigation of the drugmaker's marketing and promotional practices." Then, during "2005, the office told Lilly it was conducting an inquiry into rebate agreements involving Zyprexa and other drugs with an unnamed pharmacy benefit manager." To date, "Lilly has received subpoenas from Florida, California, and Illinois on its marketing and promotional practices," and "[t]hirty states have joined in an effort coordinated by a committee of attorneys general 'under various state consumer protection laws,'" according to the filing.