A Florida woman pleaded guilty Wednesday to obstructing a 2017 regulatory inspection in connection with an alleged scheme to fraudulently falsify clinical drug trial data, officials stated.
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 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 FDA OCI is investigating the case.