Florida Woman Charged with Falsifying Clinical Data

According to a Department of Justice (DOJ) press release dated May 11, 2021, Jessica Palacio, 34, of Miami, FL was charged with conspiring to falsify clinical trial data surrounding asthma medication for children. She worked as a study coordinator at a clinical trial firm called Unlimited Medical Research.

According to the indictment, Palacio allegedly falsified medical records to make it seem as if subjects made routine visits to Unlimited Medical Research, received physical exams from a clinical investigator, and took study drugs. The indictment alleges that none of these steps had occurred. Furthermore, according to the indictment, Palacio made a false statement to a Food and Drug Administration (FDA) regulatory investigator about falsifying clinical trial data.

Deputy Assistant Attorney General Arun G. Rao of the Justice Department’s Civil Division said of the crime, “Falsifying clinical trial data risks the health and safety of those who might later rely upon the drugs being tested. 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.”

Palacio 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.

Special Agent in Charge Justin C. Fielder of the FDA Office of Criminal Investigations, Miami Field Office, explained, “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.”