Analay Rico, 37, of Fort Lauderdale, and Daylen Diaz, 44, of Miami, worked as study coordinators at Tellus Clinical Research, according to court filings.
Rico and Diaz admitted as part of their plea deals that they conspired with others to mislead clients paying for clinical trial work meant to assess therapies for a variety of medical ailments, including opioid dependence, irritable bowel syndrome, and diabetic nephropathy.
Rico and Diaz acknowledged, among other things, that they fabricated data to give the impression that people were taking part in the studies when, in reality, they weren’t.
According to Principal Deputy Assistant Attorney General Brian M. Boynton, chief of the Justice Department’s Civil Division, “Clinical trials are the core of the drug licencing process.”
The Justice Department will keep collaborating with law enforcement to bring criminal charges against people who fudge clinical trial data for their own financial gain.
The Southern District of Florida’s U.S. Attorney, Juan Antonio Gonzalez, stated that “the public depends on the accuracy of clinical trial data.”
“Falsifying clinical data breaches the public’s confidence and puts consumer safety at risk. We will keep up our ferocious prosecution of this severe crime.
“The cornerstone of FDA’s review of a new medicine is reliable and accurate data from clinical trials,” stated Special Agent in Charge Justin C. Fielder of the FDA Office of Criminal Investigations (FDA-OCI) Miami Field Office.
“Compromised clinical trial results may affect the agency’s judgments regarding the efficacy and safety of the drug under consideration.
We’ll keep an eye on, look into, and prosecute anyone whose actions jeopardise public health or undermine the FDA clearance process.
As a result of their participation in the scheme, Duniel Tejeda, 36, of Clewiston, Florida, Eduardo Navarro, 53, of Miami, Florida, and Nayade Varona, 51, of Port St. Lucie, Florida, previously entered pleas of guilty and received sentences of 30 months in prison, 46 months in prison, and 30 months in prison, respectively.
Three other defendants, Dr. Martin Valdes, 66, of Coral Gables, Florida, Fidalgis Font, 55, of Miami, and Julio Lopez, 55, of Hialeah, who have all been indicted in connection with Tellus, will go on trial on September 27.
The situation is being looked into by FDA-OCI.
The action is being prosecuted by trial attorneys Lauren M. Elfner, Joshua D. Rothman, and Wandaly Fernández Garca of the Civil Division’s Consumer Protection Branch. Important support has been given by the Southern District of Florida’s U.S. Attorney’s Office.