According to the Department of Justice, Jessica Palacio, 37, of Miami made the false statement to a government investigator and was convicted by a jury on September 13 last year (2022) for lying to the U.S. Food and Drug Administration (FDA) investigator during a 2017 regulatory inspection of the firm conducting the drug trial.
On January 12, U.S. District Judge Darrin Gayles sentenced Palacio to 36 months in prison and three years of supervised release.
Evidence that was presented at trial showed Palacio had worked from 2013 to 2015 as a clinical research coordinator at Miami-based Unlimited Medical Research (UMR). It was one of a number of companies that had been hired to carry out a clinical trial to look at the safety of an asthma medication in young children.
The manufacturer of the unnamed drug notified the FDA of issues in the trial performed by UMR based on a review of the data.
In May 2021, a grand jury in Miami returned a two-count indictment against Palacio alleging a scheme to falsify medical records to make it appear as though pediatric subjects made scheduled visits to UMR, received physical exams from a clinical investigator, and took study drugs as required, when in fact these events had not occurred.
The indictment alleged that when Palacio was confronted by an FDA regulatory investigator about her role in the clinical trial conducted by UMR, she submitted a false affidavit claiming that she had performed a screening visit of a child subject when she had not.
Following trial, the jury found Palacio guilty of both conspiring to commit wire fraud and with making a false statement. The court subsequently granted a defense motion for a judgment of acquittal on the conspiracy charge but denied a motion for judgment of acquittal as to the false statement charge.
“Clinical trials play a critical role in establishing drug safety and efficacy,” said principal deputy assistant Attorney General, Brian Boynton, head of the Justice Department’s Civil Division. “The Justice Department will work closely with its law enforcement partners to protect the integrity of this important process.”
Special agent in charge, Justin Fielder, at the FDA Office of Criminal Investigations, Miami, said: “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. Today’s sentencing demonstrates that those who attempt to subvert the regulatory functions of the FDA by making false statements to the agency to cover up falsified data will be held accountable for their actions.”
Four co-conspirators previously pleaded guilty and were sentenced for their roles in the scheme at UMR. Yvelice Villaman Bencosme, 66, of Miami, was sentenced to 36 months’ imprisonment, and Lisett Raventos, 48, also of Miami, was sentenced to 30 months’ imprisonment. In addition, Maytee Lledo, 52, of Hialeah, Florida, was sentenced to 14 months’ imprisonment, which the court later modified to time served, and Olga Torres, 50, of Miami, was sentenced to 3 years’ probation.
The FDA Office of Criminal Investigations investigated the case.
The case was prosecuted by senior litigation counsel David Frank and trial attorney Marilee Miller from the civil division’s consumer protection branch, with the assistance of associate chief, Kyrsten Melander, for enforcement at FDA’s Office of Chief Counsel.