Office of the Attorney General
Pfizer to Pay $14m to Settle Allegations of Illegal Off-label Marketing of Urology Drug Detrol

Press Release Date:  Friday, October 21, 2011  
Contact Information:  Shelley Catharine Johnson
Deputy Communications Director
502-696-5659 (office)

Attorney General Jack Conway today announced that Kentucky has reached a settlement with pharmaceutical giant Pfizer, Inc. over allegations of illegal off-label marketing of its urology drug Detrol. The settlement concludes a government investigation into the allegations that the company engaged in off-label marketing schemes to promote the sales of Detrol for uses that were not approved by the Food and Drug Administration (FDA). The settlement will return $152,607 to the state's Medicaid program.

The FDA approved Detrol in March 1998 for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. The settlement resolves allegations that Pfizer's promotional activities were designed by the company to increase the prescribing of Detrol for uses in men for which it was not approved. These uses included treatment for benign prostate hyperplasia (BPH), bladder outlet obstruction (BOO) and lower urinary tract symptoms (LUTS). The investigation began with a whistleblower lawsuit filed in U.S. District Court in Boston, Massachusetts by two former Pfizer employees, referred to in the suit as the "relators."

"I am pleased that a settlement has been reached and that we've been able to recover funds for a vital state program," General Conway said. "The illegal off-label marketing of drugs not only puts public health at risk, it takes millions of dollars out of taxpayers' pockets."

The settlement is the result of a joint investigation by the United States Attorney's Office for the District of Massachusetts, the US Department of Justice, the attorneys for the "relators," and a state team of representatives from the Medicaid Fraud Control Units of Massachusetts, New York and Ohio.

The total value of the national civil settlement is $14 million, with $5,576,923 designated as Medicaid program recovery. Medicaid is a state administered healthcare program for the indigent and disabled which is funded jointly by the states and the federal government. The remaining portion of the civil recovery is for damages to other federally-funded health care programs (Medicare, TRICARE and the Department of Defense).

Since Attorney General Conway took office in January 2008, his Office of Medicaid Fraud and Abuse Control has recovered or been awarded more than $210 million for the state and federal Medicaid programs. These cases range from lawsuits and settlements against pharmaceutical companies to cases against individual providers.