On March 22, 2021, the DOJ issued a Press Release that a Miami physician was sentenced to 63 months in prison after pleading guilty to her role in a scheme to falsify clinical trial data regarding an asthma medication. The study coordinator also pleaded guilty and was sentenced to 30 months in prison.
The Miami physician was a licensed medical doctor who served as the primary investigator for clinical trials. The study coordinator was also the site director and director of clinical operations at the clinic.
The clinical trial was supposedly designed to investigate the safety and efficacy of an asthma medication in children between the ages of 4 and 11. Both the Miami physician and study coordinator admitted they falsified medical records to make it appear as though pediatric subjects made scheduled visits to the clinic, took study drugs, and received checks as payments.