Owners of Clinical Research Facility Plead Guilty to Fraud in Asthma Drug Trials
TL/DR –
Owners of a Florida-based clinical research facility, Angela Baquero, 49, and Ricardo Acuna, 52, have pleaded guilty to conspiracy to commit wire fraud in relation to their work on two clinical trials for asthma drugs. They admitted to making fraudulent claims regarding subject eligibility and falsifying material documents and data, resulting in fraudulent clinical research data being provided to the drug trial sponsor and to an FDA investigator. In addition to this, Doctor Matthew Teltser, who served as the clinical investigator for the trials, also pleaded guilty to making false statements to the FDA investigator.
Florida Clinical Research Facility Owners Plead Guilty to Fraud Charges
Angela Baquero, 49, and Ricardo Acuna, 52, owners of a Florida-based clinical research facility, A&R Research Group (A&R), have pled guilty to conspiracy to commit wire fraud. The charges stem from their involvement in two clinical trials designed to test potential asthma drugs. The trials were part of an approval process overseen by the U.S. Food and Drug Administration (FDA).
Role of Baquero and Acuna in A&R Research Group
Located in Pembroke Pines, Florida, A&R conducted clinical trials for new drug treatments on behalf of sponsors seeking FDA approval. Baquero acted as A&R’s clinical research director and study coordinator, while Acuna served as the facility’s regulatory and contract affairs manager.
Details of the Fraud Conspiracy
The guilty parties admitted to fraudulent activities aimed at enriching themselves. These included making false representations about subject eligibility, and falsifying vital documents and data. As a result, A&R supplied the drug trial sponsor and the FDA investigator with fraudulent clinical research data. The fraudulent enrollment of ineligible subjects and submission of data for non-participating subjects led to inflated payments from the sponsor.
Government’s Stance on Integrity of Clinical Trials
Speaking on the issue, Acting Assistant Attorney General Yaakov Roth stressed the importance of clinical trials in evaluating the safety and efficacy of potential drug treatments. He affirmed the Justice Department’s commitment to work with the FDA in prosecuting those who illegally compromise the clinical trial process for fraudulent payments.
Additional Guilty Plea Related to A&R Clinical Trials
This case follows a separate guilty plea on March 3 by Dr. Matthew Teltser, 70, who served as the clinical investigator for numerous A&R clinical trials. Teltser pled guilty to lying to an FDA investigator about his presence at every subject visit during the two asthma clinical trials.
Upcoming Court Proceedings
Further hearings for Baquero and Acuna’s cases have been scheduled for Sept. 19, and Dr. Teltser is set to be sentenced on June 10. Each defendant could face up to five years in prison. The case is being investigated by the FDA’s Office of Criminal Investigations, Miami Field Office, with prosecution by the Justice Department’s Consumer Protection Branch and assistance from the United States Attorney’s Office for the Southern District of Florida.
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