Miami, Florida - A Florida nurse practitioner and a Florida woman pleaded guilty Tuesday to their participation in a conspiracy to falsify clinical trial data.
According to court documents, Eduardo Navarro, 52, of Miami, and Nayade Varona, 50, of Port St. Lucie, worked at a clinical research site called Tellus Clinical Research. Navarro was a sub-investigator, and Varona was an assistant study coordinator. As part of their plea agreements, Navarro and Varona admitted that they agreed with one another and others to falsify data in medical records in connection with two clinical trials intended to evaluate a treatment for irritable bowel syndrome. Among other things, Navarro and Varona falsified data to make it appear as though subjects were participating in the trials when, in truth, they were not.
“The falsification of clinical trial data puts the health and safety of the public at risk,” 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.”
“Public health and safety must always take precedence over profit when new pharmaceutical drugs are being tested,” said Acting U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida. “Medical researchers needlessly endanger the public by manipulating clinical data and falsifying records. Such conduct is illegal and will be prosecuted.”
“FDA’s evaluation of a new drug begins with an analysis of reliable and accurate data from clinical trials,” said Assistant Commissioner for Criminal Investigations Catherine A. Hermsen of the Food and Drug Administration's (FDA) Office of Criminal Investigations. “Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review. We will continue to investigate and bring to justice those whose actions may subvert the FDA approval process and endanger the public health.”
Navarro and Varona both pleaded guilty before U.S. District Judge Jose E. Martinez of the Southern District of Florida to conspiracy to defraud the United States and to commit an offense against the United States. Both face a maximum penalty of five years in prison and are scheduled to be sentenced on Aug. 11. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
The FDA's Office of Criminal Investigations is investigating the 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 provided critical assistance.