Study Coordinator Charged in Scheme to Falsify Clinical Trial Data
A federal grand jury in Miami, Florida, returned an indictment today charging a Florida woman with conspiring to falsify clinical trial data regarding an asthma medication.
According to court documents, Jessica Palacio, 34, of Miami, worked as a study 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 indictment alleges that Palacio participated in 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 also alleges that when Palacio was confronted by a Food and Drug Administration (FDA) regulatory investigator about her conduct, she made a false statement to that investigator.
“Falsifying clinical trial data risks the health and safety of those who might later rely upon the drugs being tested,” said Deputy Assistant Attorney General Arun G. Rao of the Justice Department’s Civil Division. “The Department of Justice will continue to work with its partners at the Food and Drug Administration to investigate and prosecute anyone who endangers the public for financial gain.”
“When the efficacy of a new pharmaceutical drug is tested, public health and safety must always take precedence over profit,” said Acting U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida. “Medical researchers who manipulate clinical data and falsify records needlessly endanger the public and will be prosecuted.”
“Reliable and accurate data from clinical trials is the cornerstone of FDA’s evaluation of a new drug,” said Special Agent in Charge Justin C. Fielder of the FDA Office of Criminal Investigations, Miami Field Office. “Compromised clinical trial data could impact the agency’s decisions about the safety and effectiveness of the drug under review. We will continue to monitor, investigate and bring to justice those whose actions may subvert the FDA approval process and endanger the public health.”
Palacio is charged with conspiracy to commit wire fraud and making a false statement. The defendant is expected to make her initial court appearance later this week in the U.S. District Court for the Southern District of Florida. If convicted, she faces a maximum penalty of 20 years in prison for conspiracy to commit wire fraud, and five years in prison for making a false statement. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
The FDA’s Office of Criminal Investigations is investigating the case.
Trial Attorneys Joshua D. Rothman and Kara M. Traster of the Civil Division’s Consumer Protection Branch are prosecuting the case, and the U.S. Attorney’s Office for the Southern District of Florida provided critical assistance.
An indictment is merely an allegation and all defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.