In January, a federal judge sentenced a Florida man to 30 months in prison for participating in conspiracy to falsify clinical trial data.
U.S. District Judge, Robert Scola Jr., of the Southern District of Florida, entered the sentence for Duniel Tejada, 35, of Clewiston, Florida, according to a recent Department of Justice press release. Tejeda plead guilty to his charges and was ordered to pay more than $2 million in restitution.
“Reliable and accurate data from clinical trials is the cornerstone of (the) FDA’s (Food and Drug Administration’s) evaluation of a new drug’,’ said Catherine Hermsen, Assistant Commissioner for the FDA Office of Criminal Investigations, in the release. “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 public health.”
Tejeda worked as a project manager for Tellus Clinical Research, a Miami-based research firm, the release stated. He admitted that he falsified clinical trial data that evaluated medical conditions such as opioid dependency and diabetic nephropathy.
According to a DOJ release in March 2021, Tejada’s infractions occurred from at least February 2014 to at least July 2016.
“Clinical trials help ensure that new drugs are safe and effective for the public,” said Acting Assistant Attorney General, Brian Boynton, Justice Department Civil Division, in the release. “Falsifying clinical trial data undermines a critical component of the drug approval process. The Department of Justice will continue to work with our partners at the Food and Drug Administration to investigate and prosecute anyone who puts personal profit over public health by falsifying clinical trial data.”
Tejada was one of several Tellus Clinical Research employees who were implicated in the conspiracy, according to the DOJ.
