FOR IMMEDIATE RELEASE
Thursday, September 7, 2023
A jury in Miami convicted two defendants on Sept. 5 in a scheme involving the falsification and fabrication of clinical trial data.
On Sept. 5, Miguel Angel Montalvo Villa, 53, and Ivette Maria Portela Martinez, 53, both of Miami, were each convicted of one count of conspiracy to commit wire fraud and one count of wire fraud. Montalvo also was convicted of making a false statement to a regulatory investigator with the Food and Drug Administration (FDA).
Previously, on Sept. 13, 2022, Montalvo and Portela were charged in a three-count indictment returned by a federal grand jury. The indictment alleged that, from September 2015 through March 2018, the defendants and a co-conspirator conspired to falsify clinical trial data for profit while working at AMB Research Center Inc. (AMB), a medical clinic located in Miami, Florida.
According to court documents and evidence presented during the trial, Montalvo was co-owner, president and chief executive officer of AMB, and Portela was an employee who, among other things, served as AMB’s pharmacist and data entry specialist. Montalvo and Portela used the names of individuals without their knowledge or permission, and listed those individuals as subjects who who were enrolled and participated in a clinical trial for a drug that was being developed to treat Clostridium difficile-associated diarrhea (CDAD), a moderate to serious form of diarrhea. None of the listed individuals knew that the defendants were using their personal information to falsely portray them as subjects in the CDAD clinical trial. Montalvo and Portela falsified hundreds of pages of documents and entered that false information into clinical trial databases, to make it appear as though the purported subjects had CDAD and were fully participating in the clinical trial, when in fact they were not.
In connection with a February 2018 FDA regulatory inspection of AMB, Montalvo told the FDA regulatory investigator that AMB’s principal investigator had obtained informed consent from all purported CDAD clinical trial subjects, when in fact (and as Montalvo knew) the principal investigator had not done so. As part of the conspiracy, Montalvo also submitted falsified and fraudulent invoices, totaling $277,920.70, in order for AMB to receive payments for conducting the CDAD clinical trial.
Sentencing is scheduled for Nov. 30 before the Honorable K. Michael Moore of the U.S. District Court for the Southern District of Floria.
“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.
Topic
CONSUMER PROTECTION
Component
Civil Division
Press Release Number: 23-978
http://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/miami-medical-clinic-owner-and-pharmacist-convicted-clinical-trial-fraud-scheme
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