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.
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.”