Two owners of a clinical research facility pleaded guilty today in the U.S. District Court for the Southern District of Florida to conspiracy to commit wire fraud in connection with their work on two clinical trials testing drugs designed to treat asthma.
According to court documents, Angela Baquero, 49, and Ricardo Acuna, 52, both of Weston, Florida, owned A&R Research Group (A&R), located in Pembroke Pines, Florida. A&R was a medical research facility that conducted clinical trials of prospective new drug treatments on behalf of drug sponsors seeking approval from the U.S. Food and Drug Administration (FDA). Baquero served as A&R’s clinical research director and study coordinator. Acuna served as A&R’s regulatory and contract affairs manager.
Pursuant to their plea agreements, Baquero and Acuna admitted to conspiring to unlawfully enrich themselves by making fraudulent representations to the asthma drug trial sponsor regarding subject eligibility, and falsifying and fabricating material documents and data, including case histories, spirometry readings, and echocardiogram data. As a result of the conspiracy, A&R provided fraudulent clinical research data to the drug trial sponsor and to an FDA investigator. According to the plea agreements, fraudulently enrolling subjects who did not qualify, and submitting data for subjects who were not participating, allowed A&R to inflate payments due from the sponsor.
“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.”
The guilty pleas by Baquero and Acuna follow a March 3 guilty plea to a separate criminal information by Dr. Matthew Teltser, 70, of Hollywood, Florida, who served as the clinical investigator for numerous A&R clinical trials. Teltser pleaded guilty to making false statements to an FDA investigator regarding his work on the trials. According to his plea agreement, Teltser was the clinical investigator responsible for performing physical examinations on subjects and maintaining accurate records of data pertinent to the clinical trial. Teltser admitted that, during an FDA inspection, he knowingly and falsely told the FDA investigator that he had been present at every subject visit during the two asthma clinical trials.
Baquero and Acuna’s matters are set for further hearings before U.S. District Judge David S. Leibowitz on Sept. 19. Teltser is scheduled to be sentenced by U.S. District Judge Raag Singhal on June 10. Each defendant faces a maximum penalty of five years in prison.
FDA’s Office of Criminal Investigations, Miami Field Office, investigated the case.
Trial Attorneys Andrew K. Crawford and Brianna M. Gardner of the Justice Department’s Consumer Protection Branch are prosecuting the case. The United States Attorney’s Office for the Southern District of Florida has provided critical assistance.
This crime news article "Medical Clinic Owners and Clinical Investigator Plead Guilty in Connection with Fraudulent Clinical Drug Trials" was originally found on https://www.justice.gov/usao/pressreleases