According to evidence presented at trial, Jessica Palacio, 36, of Miami, worked from 2013 to 2015 as a clinical research coordinator at a clinical trial firm in Miami called Unlimited Medical Research. Unlimited Medical Research was one of many companies hired to conduct a clinical trial designed to investigate the safety and efficacy of an asthma medication in children. The drug manufacturer identified issues in the trial performed by the company based on a review of data and notified the Food and Drug Administration (FDA).
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 Unlimited Medical Research, received physical exams from a clinical investigator, and took study drugs as required, when in fact these things 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 United Medical Research, she made a false statement by submitting 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. U.S. District Judge Darrin P. Gayles 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.
“The safety of our nation’s prescription medications depends on the accuracy of the clinical studies reported to the FDA,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division. “The Department will continue to work with its law enforcement partners to protect the integrity of this important process.”
“This announcement demonstrates that those who attempt to subvert the regulatory functions of the FDA by making false statements to the agency will be held accountable for their actions,” said Special Agent in Charge Justin C. Fielder of the FDA Office of Criminal Investigations Miami Field Office. “We commend the efforts of the Department of Justice for vigorously pursuing the prosecution of this matter.”
Palacio is scheduled to be sentenced on Nov. 21, 2022.
The FDA Office of Criminal Investigations investigated the case.
The case was prosecuted by Senior Litigation Counsel David A. Frank and Trial Attorney Marilee L. Miller from the Civil Division’s Consumer Protection Branch, with the assistance of Kyrsten Melander, Associate Chief for Enforcement at the FDA’s Office of Chief Counsel.