Drugs

Jury Convicts 2 for Clinical Trial Fraud

A Florida federal court jury has convicted two defendants in a scheme involving the falsification and fabrication of clinical trial data. The jury on 9/5 convicted Miguel Angel Montalvo Villa and Ivette Maria Portela Martinez, both of Miami, on one count each of conspiracy to commit wire fraud and of wire fraud. Montalvo also was convicted of making a false statement to FDA, according to a Department of Justice release.

A grand jury indictment had charged that from 9/2015 through 3/2018, the defendants and a co-conspirator conspired to falsify clinical trial data for profit while working at AMB Research Center, a Miami, FL, medical clinic. The department says that Montalvo was co-owner, president, and CEO of AMB, and Portela was its pharmacist and data entry specialist. They reportedly used the names of individuals without their knowledge or permission and listed them as subjects who were enrolled and participated in a clinical trial for a drug being developed to treat Clostridium difficile-associated diarrhea.

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 trial subjects had the condition and were fully participating in the clinical trial, the statement says.

During an FDA inspection at AMB, Montalvo reportedly told the agency investigator that the principal investigator had obtained informed consent from all purported trial subjects. As part of the conspiracy, the department says, Montalvo submitted falsified and fraudulent invoices totaling $277,920.70 for AMB to be paid for conducting the trial.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome