Eli Lilly & Co. said Wednesday that it received a subpoena in November from a U.S. grand jury in Pennsylvania seeking documents involving the marketing of the company’s bestselling drug, the antipsychotic Zyprexa.
The Indianapolis drug maker is cooperating in state and U.S. investigations into its marketing practices, according to a statement from spokeswoman Marni Lemons.
Her e-mail also cited “many speculative statements” in a New York Times article that said the company might pay more than $1 billion to settle the investigation.
Connecticut Atty. Gen. Richard Blumenthal told the Reuters news service late Wednesday that his office was involved in the investigation and negotiations with the company over Zyprexa.
“There are discussions,” Blumenthal said. But he declined to confirm that those were settlement talks.
The probe centers on marketing and promotional practices related to the pill’s sales in the United States, including communication with doctors and the way the company paid consulting physicians and other advisors, Lemons said.
Lilly has been accused of promoting the drug for nonapproved, so-called off-label, uses and of playing down side effects such as weight gain, which raises the risk of diabetes.
Doctors are free to prescribe drugs in any way they see fit, but drug companies may promote them only for uses approved by U.S. regulators.
Sales of Zyprexa tablets, also used to treat bipolar disorder, rose 9% to $4.76 billion last year, accounting for about a quarter of Lilly’s revenue.
The New York Times, citing “several people involved in the investigation,” said in a story on its website that settlement discussions with states and the U.S. government were underway, led by the U.S. attorney’s office in Philadelphia. A $1-billion payment could be the largest for breaking laws on how medications are promoted, the newspaper wrote.
“We regularly have discussions with the government,” Lemons said. She didn’t comment further on the story.
The U.S. attorney’s office in Philadelphia is “not confirming anything in the New York Times article,” spokeswoman Patty Hartman said. Joseph Trautwein, an assistant U.S. attorney, declined to comment.
In March 2004, the U.S. attorney’s office told Lilly that it had begun a civil investigation of the drug maker’s marketing and promotional practices, according to a Nov. 5 regulatory filing. In 2005, the office told Lilly it was conducting an inquiry into rebate agreements involving Zyprexa and other drugs with an unnamed pharmacy benefits manager, the filing reported.
Lilly has received subpoenas from California, Florida and Illinois on its marketing and promotional practices, according to the filing. Thirty states have joined in an effort coordinated by a committee of attorneys general “under various state consumer protection laws,” the filing said.
The company is cooperating in all of these investigations, Lilly said.
In September, Lilly agreed to settle its claims against a doctor who leaked secret marketing documents on Zyprexa to the New York Times. David Egilman, an expert witness for patients suing Lilly in U.S. court in Brooklyn, N.Y., agreed to pay $100,000 to the drug maker. Lilly said Egilman violated an order to keep the documents secret.
This month, Lilly settled 950 claims related to Zyprexa on allegations that it caused diabetes and other illnesses. The company has said it faces an additional 1,100 cases.
Bloomberg News and Reuters were used in compiling this report.