Drugs

Doctor, Staff Charged with Falsifying Trial Data

A Florida federal grand jury has indicted a Pines Care Research Center doctor and two staff members for their roles in an alleged scheme to falsify data in clinical trials of prospective new drug treatments. A Department of Justice news release says Dr. Jaynier Moya of Southwest Ranches, FL, co-owned Pines Care and was principal investigator for the research studies.

According to the department, beginning no later than 2019, the defendants allegedly fabricated testing data and falsified other records while conducting clinical trials sponsored by a pharmaceutical development company. As alleged in the charging documents, the news release says, the defendants falsified records to make it appear that human subjects had taken the study medications and undergone testing to evaluate the study medications’ effects as called for in the trial protocol when, in fact, they had not.

The defendants allegedly used identification documents from people who did not actually participate in trials to create false records purporting to show those individuals participated and generated test results.

Each defendant is charged with conspiracy to commit wire fraud and also with substantive wire fraud. If convicted, they face a statutory maximum penalty of 20 years in prison on the conspiracy charge and a statutory maximum penalty of 20 years in prison on the substantive wire fraud charge.

The release says the FDA Office of Criminal Investigations, Miami, FL, field office is investigating the case.

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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