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A federal judge sentenced a Florida nurse practitioner and a Florida woman to prison terms today in connection with their participation in a conspiracy to falsify data related to clinical drug trials.

U.S. District Judge Jose E. Martinez of the Southern District of Florida sentenced Eduardo Navarro, 52, of Miami, to 46 months in prison, and Nayade Varona, 50, of Port St. Lucie, to 30 months in prison. The court also ordered the defendants to pay $2,134,503 in restitution. According to court documents, Navarro and Varona worked at a clinical research site called Tellus Clinical Research (Tellus). Navarro, a nurse practitioner, was a sub-investigator at Tellus, and Varona was an assistant study coordinator. As part of their plea agreements, Navarro and Varona admitted that they conspired with others to falsify data in connection with two clinical trials by, among other things, fabricating medical records to make it appear as though subjects were participating in the clinical trials when, in truth, they were not.

“By falsifying clinical trial data, the defendants undermined a crucial component of the drug approval process,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The Justice Department will continue to work with its partners at the Food and Drug Administration to investigate and prosecute anyone who engages in this conduct.”

“Falsifying clinical trial data puts the public’s health at risk,” said Acting U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida. “Compromised clinical data jeopardizes the researchers’ ability to evaluate the safety and efficacy of new drugs. Prosecuting these cases will continue to be a top priority for our office.”

“The FDA will continue to thoroughly investigate and bring to justice those who try to undermine clinical trials, an important part of the agency’s regulatory review of new drugs,” said Assistant Commissioner for Criminal Investigations Catherine Hermsen of the Food and Drug Administration (FDA). “The agency will aggressively pursue violations that threaten the integrity of clinical trial data in order to protect the public’s access to safe and effective products.”

The FDA’s Office of Criminal Investigations investigated this case.

Trial Attorneys Lauren M. Elfner and Joshua D. Rothman 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.

Author: Press Release