A Florida woman was indicted Tuesday for falsifying clinical trial data of a potential children’s asthma medication pending approval by the Food and Drug Administration (FDA).
34-year-old Jessica Palacio of Miami allegedly committed the crime while working as a study coordinator at a clinical trial firm in Miami called Unlimited Medical Research, according to a press release from the U.S. Department of Justice (DOJ). The defendant was charged with conspiracy to commit wire fraud and making a false statement.
Study Coordinator Charged in Scheme to Falsify Clinical Trial Data https://t.co/rVkTmHUFHr
— Justice Department (@TheJusticeDept) May 11, 2021
A federal grand jury’s indictment alleges that Palacio was part of a criminal scheme aiming to falsify medical records to make it appear as though the trial’s children subjects made scheduled visits to the trial firm, took study drugs and underwent comprehensive physical exams as required by the FDA, according to the DOJ. In reality, none of that actually took place.
When confronted by an FDA regulatory investigator about her conduct, Palacio allegedly made a false statement with the hope of covering up the crime. (RELATED: Medical Staff Falsified Clinical Trial Data And Fabricated Lab Results, Unsealed Indictment Shows)
“When the efficacy of a new pharmaceutical drug is tested, public health and safety must always take precedence over profit,” Acting U.S. Attorney for the Southern District of Florida Juan Gonzalez said, according to the report. “Medical researchers who manipulate clinical data and falsify records needlessly endanger the public and will be prosecuted.”
If convicted, Palacio faces the maximum sentence of 20 years in prison for conspiracy to commit wire fraud and five years in prison for making a false statement, according to the DOJ.