Florida Resident Pleads Guilty to Conspiracy to Falsify Clinical Trial Data
A Florida resident pleaded guilty to conspiring to falsify clinical trial data regarding an asthma medication, the Department of Justice announced today.
Lisett Raventos, 46, of Miami, Florida, pleaded guilty today in the U.S. District Court for the Southern District of Florida today to one count of conspiracy to commit wire fraud. Raventos was the site director, the director of clinical operations, and a study coordinator at a medical clinic named Unlimited Medical Research (Unlimited Medical) in Miami, Florida. In pleading guilty, Raventos admitted that from approximately 2013 to 2016, she participated in a scheme to defraud an unnamed pharmaceutical company by fabricating the data and participation of subjects in a clinical trial at Unlimited Medical. The clinical trial was designed to investigate the safety and efficacy of an asthma medication in children between the ages of four and eleven. Raventos admitted that she falsified medical records to make it appear as though pediatric subjects made scheduled visits to Unlimited Medical, took study drugs as required, and received checks as payment.
“Clinical trials help ensure that new drugs are safe and effective for the public, and this defendant undermined that process,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “The Department of Justice will continue to work hand-in-hand with the Food and Drug Administration (FDA) to investigate and prosecute fraudsters who put personal profit before public health.”
“Fraud in the conduct of clinical trials is simply unacceptable, especially where the drug under investigation was meant to serve children and other vulnerable populations,” said U.S. Attorney Ariana Fajardo Orshan for the Southern District of Florida. “I thank our partners at the FDA’s Office of Criminal Investigations, Miami Field Office, for their work in investigating this scheme.”
“Reliable clinical trial data is a foundation for FDA drug approval. Falsifying that data leaves consumers at risk of taking drugs that are neither safe nor effective,” said Special Agent in Charge Justin C. Fielder, FDA Office of Criminal Investigations Miami Field Office. “We will continue to investigate and bring to justice those who endanger the public health when they engage in conduct that might subvert the FDA approval process.”
Raventos pleaded guilty before U.S. District Judge Beth Bloom. Raventos is the first defendant to plead guilty in connection with the scheme. Three other defendants were charged along with Raventos, and they are presumed innocent until proven guilty beyond a reasonable doubt. When sentenced, Raventos faces a maximum penalty of up to 20 years in prison.
Assistant Director Clint L. Narver and Trial Attorneys Joshua Rothman, Jocelyn Hines, and Kara M. Traster of the Department of Justice’s Consumer Protection Branch are prosecuting the case. The U.S. Food and Drug Administration’s Office of Criminal Investigations, Miami Field Office, investigated the case, and the U.S. Attorney’s Office of the Southern District of Florida has provided critical assistance.