Owners of clinical research facility admit to falsifying drug trials

WESTON, Fla. — The owners of a Florida clinical research facility have pleaded guilty to conspiracy to commit wire fraud in connection with fraudulent data submitted for clinical drug trials, the U.S. Department of Justice (DOJ) announced.

According to the DOJ, Angela Baquero, 49, and Ricardo Acuna, 52, both of Weston, owned A&R Research Group, a medical research facility in Pembroke Pines that conducted clinical trials on behalf of drug sponsors seeking approval from the U.S. Food and Drug Administration (FDA). Prosecutors said the pair admitted to falsifying trial data for two asthma drug studies.

According to court records, Ms Baquero and Mr Acuna conspired to enrich themselves by making fraudulent representations about subject eligibility and falsifying case histories, spirometry readings, and echocardiogram data.

The fraudulent information was reportedly provided to the drug trial sponsor and an FDA investigator, allowing the clinic to collect inflated payments.

The case also involves Dr Matthew Teltser, 70, of Hollywood, who previously pleaded guilty on March 3 to making false statements to an FDA investigator. Dr Teltser reportedly claimed he was present for every patient visit in the asthma drug trials despite evidence to the contrary.

“Clinical trials are essential to evaluating the safety and efficacy of potential drug treatments,” said Acting Assistant Attorney General Yaakov Roth of the Justice Department’s Civil Division.

“The Justice Department will continue to work with the FDA to investigate and prosecute those who illegally undermine the integrity of the clinical trial process to facilitate fraudulent payments.”

Ms Baquero and Mr Acuna are scheduled for hearings before U.S. District Judge David S. Leibowitz on Sept. 19. Dr Teltser is set for sentencing by U.S. District Judge Raag Singhal on June 10. Each defendant faces a maximum sentence of five years in federal prison.

The case was investigated by the FDA’s Office of Criminal Investigations, Miami Field Office. Trial Attorneys Andrew K. Crawford and Brianna M. Gardner of the Justice Department’s Consumer Protection Branch are prosecuting the case with assistance from the U.S. Attorney’s Office for the Southern District of Florida.