Home Federal News Florida Co-Owner of Clinical Trial Company Pleads Guilty to Obstructing FDA Inspection | OPA
Florida Co-Owner of Clinical Trial Company Pleads Guilty to Obstructing FDA Inspection | OPA
A Florida woman pleaded guilty today to obstructing a 2017 regulatory inspection in connection with an alleged scheme to fraudulently falsify clinical drug trial data.
According to court documents, Olga Torres, 49, of Miami, co-owned a clinical research site 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. As part of her plea agreement, Torres admitted that she knowingly lied to a U.S. Food and Drug Administration (FDA) investigator during a 2017 regulatory inspection concerning the firm. Specifically, Torres admitted that she falsely portrayed the clinical trial as having been conducted legitimately and honestly, when in fact Torres knew that certain data associated with the clinical trial had been falsified. Three other defendants — Yvelice Villaman Bencosme M.D., Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the clinical trial at Unlimited Medical Research.
"Clinical trials help ensure the safety of new drugs, and falsifying clinical trial data can put the public at risk," said Deputy Assistant Attorney General Michael D. Granston of the Justice Department's Civil Division. "We will continue to work with our partners at the FDA to investigate and prosecute those who undermine the integrity of the clinical trial process."
"The public depends on the accuracy and integrity of clinical trial data," said U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida. "Falsifying clinical data violates the public's trust and endangers the safety of consumers. Those who unlawfully profit by compromising the public's health in this way commit serious crimes and will be prosecuted."
"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 Assistant Commissioner Catherine A. Hermsen for the FDA Office of Criminal Investigations (OCI). "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."
The FDA OCI is investigating the case.
Trial Attorneys Joshua D. Rothman and Marilee L. Miller and Senior Litigation Counsel David Frank of the Civil Division's Consumer Protection Branch are prosecuting the case. The U.S. Attorney's Office for the Southern District of Florida provided critical assistance.