Missouri CRO fined for falsifying clinical trial work for Boehringer
PPS Clinical Research reportedly paid a $68,000 fine and pled guilty to a federal obstruction charge after acknowledging an employee at the CRO had doctored patient records for clinical trial work on Boehringer Ingelheim's Flibanserin, a "female Viagra" drug shot down last year by an expert panel. Chesterfield, MO-based PPS also paid $206,000 to settle a civil case.
The St. Louis Post-Dispatch reported that a PPS staffer falsified patient records provided to Boehringer. And the CRO still faces an FDA investigation that threatens to bar PPS's president, Richard Muckerman II, from working on any future clinical trials.
A lawyer for PPS, Jim Crowe III, said the records were doctored by a former employee and the company was now being held liable for that individual's actions. The former staffer suffered from "serious health issues that led her to not perform her job properly and (she) did some things that rendered (her actions) difficult to detect." Muckerman, he added, was cited in the case solely due to his position with the company.
U.S. Attorney Richard Callahan noted the plea and settlement "settle the matter."
- here's the story from the St. Louis Post-Dispatch