Florida

Florida Woman Sentenced to Prison Pediatric Asthma Drugs

A federal judge sentenced a Florida woman to jail for making false statements to a government investigator in connection with a clinical trial examining the effectiveness of asthma drugs in children.

Jessica Palacio, 37, of Miami, was convicted by a jury on September 13, 2022 of lying to a U.S. Food and Drug Administration (FDA) investigator during a 2017 regulatory inspection of the company conducting the drug trial would have. On January 12, US District Judge Darrin P. Gayles sentenced Palacio to 36 months in prison and three years of supervised imprisonment.

According to evidence presented at the trial, from 2013 to 2015, Palacio worked as a clinical research coordinator at a Miami clinical trials company called Unlimited Medical Research (UMR). UMR was one of many companies contracted to conduct a clinical trial to investigate the safety of an asthma drug in children. The drugmaker identified issues in the company’s study based on a review of the data and notified the FDA.

In May 2021, a Miami grand jury returned a two-count indictment against Palacio alleging a plan to falsify medical records to make it appear that pediatric subjects had scheduled visits to UMR, physical exams from a clinical one Investigator received and study medication taken as required if these events did not actually occur. The indictment alleged that when confronted by an FDA investigator about her role in the clinical trial being conducted by UMR, Palacio filed a false affidavit claiming that she conducted a screening visit on a child , although this was not the case.

After the trial, the jury found Palacio guilty of both conspiracy to wire fraud and making false testimony. The court subsequently granted a defense motion for acquittal on the conspiracy charge, but denied a motion for acquittal on the misrepresentation charge.

“Clinical trials play a critical role in determining drug safety and efficacy,” said Brian M. Boynton, deputy assistant attorney general, chief of the civil division at the Justice Department. “The Department of Justice will work closely with its law enforcement partners to protect the integrity of this important process.”

“Reliable and accurate clinical trial data is the cornerstone of the FDA’s evaluation of a new drug,” said Special Agent in Charge Justin C. Fielder of the FDA’s Office of Criminal Investigations Miami Field Office. ‚ÄúCompromised clinical trial data could affect agency decisions about the safety and efficacy of the drug under investigation. Today’s sentencing shows that those who attempt to undermine FDA’s regulatory functions 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 convicted for their role in the UMR scheme. Yvelice Villaman Bencosme, MD, 66, of Miami, was sentenced to 36 months in prison and Lisett Raventos, 48, also of Miami, was sentenced to 30 months in prison. In addition, Maytee Lledo, 52, of Hialeah, Fla., was sentenced to 14 months in prison, which the court later adjusted to reflect 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 A. Frank and Trial Attorney Marilee L. Miller from the Civil Division’s Consumer Protection Division with assistance from Kyrsten Melander, Deputy Chief of Enforcement in the FDA’s Office of Chief Counsel.

Click here to read the full press release on the DOJ website.

Press release number: 23-43

© 2023 The US Department of JusticeNational Law Review, Volume XIII, Number 16

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