FLORIDA — A jury has found a pharmacist and the owner of a medical clinic in Florida guilty of a plot involving the fabrication and falsification of clinical trial data, said the U.S. Department of Justice (DOJ).
Miami residents Miguel Angel Montalvo Villa and Ivette Maria Portela Martinez, both 53, have been found guilty of one count of conspiring to conduct wire fraud as well as one count of actual wire fraud. Montalvo was also found guilty of lying to a Food and Drug Administration regulatory investigator (FDA).
Prior to this, on September 13, 2022, a federal grand jury delivered a three-count indictment against Montalvo and Portela. The indictment claimed that while employed at AMB Research Center Inc. (AMB), a medical facility in Miami, between September 2015 and March 2018, the defendants and a co-conspirator planned to falsify clinical trial data for financial gain.
According to court records and testimony given at trial, Portela was a worker who, among other things, worked as AMB’s pharmacist and data entry expert, while Montalvo was the company’s co-owner, president, and chief executive officer.
Evidence at the trial revealed that, without their knowledge or consent, Montalvo and Portela utilized the identities of persons and identified them as participants in a clinical study for a medication being developed to treat Clostridium difficile-associated diarrhea (CDAD), a moderate to severe type of diarrhea.
None of the people on the list was aware that the defendants were misrepresenting them as participants in the CDAD clinical research by exploiting their personal data, said the DOJ.
According to the DOJ, to make it seem as if the alleged patients had CDAD and were actively taking part in the clinical research when they really weren’t, Montalvo and Portela fabricated hundreds of pages of paperwork and inserted that bogus information into databases used for clinical trials.
In connection with an FDA regulatory inspection of AMB in February 2018, Montalvo reportedly misled the FDA regulatory investigator by claiming that the principal investigator of AMB had obtained informed consent from all alleged CDAD clinical trial participants, even though Montalvo was aware that this was not the case.
In order for AMB to be compensated for carrying out the CDAD clinical research, Montalvo allegedly filed false and fraudulent invoices totaling $277,920.70 as part of the conspiracy.
The U.S. District Court for the Southern District of Florida’s Honorable K. Michael Moore will preside over the sentencing on Nov. 30.
“Truthful clinical trial data is essential to ensuring that new drug treatments are safe and effective,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division.
“The Justice Department will continue to work with its law enforcement partners to prosecute those who intentionally falsify clinical trial data for personal profit.”
“Reliable and accurate data from clinical trials is the cornerstone of FDA’s drug approval process. The jury’s finding demonstrates that those who attempt to subvert the regulatory functions of the FDA by making false statements to the agency will be held accountable for their actions,” said Special Agent in Charge Justin C. Fielder of the FDA Office of Criminal Investigations Miami Field Office.
“We commend the efforts of the Department of Justice for vigorously pursuing the prosecution of this matter.”
FDA’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.
The Justice Department’s Consumer Protection Branch prosecuted the case.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Southern District of Florida, visit its website at www.justice.gov/usao-sdfl.