Making false claims to FDA investigators is an actual crime that can net you serious prison time, as one Florida CRC working a pediatric drug trial discovered.

Jessica Palacio, a CRC for Miami-based Unlimited Medical Research (UMR), received a 36-month prison sentence plus three years of supervised release after her conviction in September 2022 for lying to an agency investigator during a 2017 inspection of a children’s asthma drug clinical trial. She was also found guilty of conspiring to commit wire fraud, but the judge granted a defense motion for a judgment of acquittal on that charge.

According to the Department of Justice, evidence shown during the court trial revealed that, after reviewing clinical trial data submitted by UMR and finding issues, the unnamed sponsor alerted the FDA.

Palacio was indicted by a grand jury in May 2021 for allegedly falsifying records to make it appear as if participants made scheduled visits to the site, underwent physical exams and took the trial drug, when none of these things actually happened. The indictment claimed that after questioning by an FDA investigator about her role in the trial, she submitted an affidavit falsely stating that she conducted a screening visit of a pediatric trial participant.

“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,” said Special Agent in Charge Justin Fielder of the FDA’s Office of Criminal Investigations Miami Field Office.

Palacio was part of a scheme at UMR to falsify trial data in exchange for payment. In total, four other co-conspirators previously pled guilty and all but one were sentenced to time in prison for their roles, including the primary investigator and the site director. Palacio is the latest conspirator sentenced for participating in the data falsification scheme.