Two Florida women pleaded guilty today in connection with their participation in a conspiracy to falsify clinical trial data.
According to court documents, Analay Rico, 37, of Fort Lauderdale, and Daylen Diaz, 44, of Miami, worked as study coordinators at a clinical research site called Tellus Clinical Research. As part of their plea agreements, Rico and Diaz admitted that they agreed with others to defraud clients paying for clinical trial work intended to evaluate treatments for various medical conditions, including opioid dependency, irritable bowel syndrome and diabetic nephropathy. Among other things, Rico and Diaz admitted they falsified data to make it appear as though subjects were participating in the trials when, in truth, they were not.
“Clinical trials are the foundation of the drug approval process,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department will continue to work with its law enforcement partners to prosecute those who falsify clinical trial data for personal profit.”
“The public relies on the accuracy of clinical trial data,” said U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida. “Falsifying clinical data endangers the safety of consumers and violates the public’s trust. It is a serious crime that we will continue to vigorously prosecute.”
“Reliable and accurate data from clinical trials is the cornerstone of FDA’s evaluation of a new drug,” said Special Agent in Charge Justin C. Fielder of the FDA Office of Criminal Investigations (FDA-OCI) Miami Field Office. “Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review. We will continue to monitor, investigate and bring to justice those whose actions may subvert the FDA approval process and endanger the public health.”
Duniel Tejeda, 36, of Clewiston, Florida, Eduardo Navarro, 53, of Miami, Florida, and Nayade Varona, 51, of Port St. Lucie, Florida, previously pleaded guilty and were sentenced to 30 months in prison, 46 months in prison, and 30 months in prison, respectively, for their roles in the scheme. The trial is set for Sept. 27, in the case of three other defendants, Dr. Martin Valdes, 66, of Coral Gables, Florida, Fidalgis Font, 55, of Miami, and Julio Lopez, 55, of Hialeah, all charged by indictment in connection with Tellus.
FDA-OCI is investigating the case.
Trial Attorneys Lauren M. Elfner, Joshua D. Rothman and Wandaly Fernández García of the Civil Division’s Consumer Protection Branch are prosecuting the case. The U.S. Attorney’s Office for the Southern District of Florida has provided critical assistance.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Southern District of Florida, visit https://www.justice.gov/usao-sdfl.
An indictment is merely an allegation, and all defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.