“Clinical trials are essential in determining the safety and effectiveness of drug treatments,” said Principal Deputy Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division.
“The Justice Department will continue to work with its law enforcement partners to prosecute anyone who intentionally falsifies this critical data for personal profit.”
Senior U.S. District Judge Donald Graham sentenced Analay Rico, 37, of Fort Lauderdale, to 40 months in prison and Daylen Diaz, 44, of Miami, to 24 months in prison. The court also ordered Rico and Diaz to pay approximately $2.1 million in restitution.
According to court documents, Rico worked as a lead study coordinator for a clinical research firm based in Miami called Tellus Clinical Research (Tellus). Diaz was a research assistant and assistant study coordinator at Tellus.
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.
“It’s disgraceful when a criminal preys upon patients in a health care setting,” said U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida. “We will prosecute perpetrators who do to the fullest extent of the law.”
Catherine Hermsen, FDA Assistant Commissioner for Criminal Investigations, added: “Reliable and accurate data from clinical trials is the cornerstone of FDA’s evaluation of a new drug.
“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.”
Co-conspirators
Three co-conspirators previously pleaded guilty and were sentenced for their roles in the scheme. Eduardo Navarro, 53, of Miami, was sentenced to 46 months imprisonment; Duniel Tejeda, 36, of Clewiston, Florida, was sentenced to 30 months imprisonment; and Nayade Varona, 51, was sentenced to 30 months imprisonment.
Trial against three remaining defendants charged by indictment in connection with Tellus, Dr. Martin Valdes, 66, of Coral Gables, Florida, Fidalgis Font, 55, of Miami, and Julio Lopez, 55, of Hialeah, Florida, is currently set for Jan. 10, 2023.