The FDA, along with the DOJ’s Consumer Protection Branch, mentioned clinical research fraud as an area of heightened concern in late 2019. The COVID-19 pandemic only made the concern more urgent for federal investigators. As of March 2021, more than 3,000 clinical research trials related to COVID-19 were pending. The federal government’s interest in targeting fraudsters during the pandemic has trickled down to sponsors, CROs (contract research organizations), and investigators involved in clinical research trials.
Recent Notable Cases
In early March 2021, the DOJ announced indictments for several federal charges in connection with an investigation into a Kendall, Florida research clinic. The owner, primary investigator, and two employees at Tellus Clinical Research allegedly falsified and invented data in connection with several testing phases of various drugs. The facility tested various drugs designed to treat opioid dependence, irritable bowel syndrome, and diabetic nephropathy during the period mentioned in the DOJ’s announcement.
Among the four defendants facing charges in this case, there are charges of money laundering, conspiracy to commit mail fraud, conspiracy to commit wire fraud, and making false statements to FDA inspectors. Federal prosecutors allege that the four defendants:
Enrolled testing subjects who did not meet testing criteria;
Falsified medical records of multiple testing subjects;
Falsified laboratory results; and
Lied about the subjects having taken the drugs being tested.
Prior to the Tellus Clinical Research case, the historic National Health Care Fraud and Opioid Takedown Operation yielded 19 indictments among eight defendants who allegedly participated in clinic research trial fraud. The charges largely mirror the Tellus Clinical Research indictments in addition to aggravated identity theft, conspiracy to defraud the United States, and failing to maintain adequate records. One notable factor, in this case, is that employees of both the research facility and CRO are implicated.
Where is the DOJ’s Focus?
Traditionally, FDA and DOG investigators have focused on malefactors working for clinical research facilities more than fraud allegedly committed by sponsors and CROs. However, recent trends strongly suggest that any clinical research players are vulnerable. Adhering to compliance standards has never been more important. CROs need strong self-reporting mechanisms for any discrepancies or irregularities in data given by research facilities. As long as millions of dollars are at stake in clinical research trials, you can expect aggressive oversight from federal agencies.
Get Help From Aggressive and Experienced Counsel
Experts expect indictments connected to clinical research fraud to continue and, quite possibly, increase in the near future. Defendants deserve a law firm that is prepared to represent them at a high level and aggressively protect their rights. Barry M. Wax, Attorney at Law has decades of experience defending clients against myriad federal charges. Contact our team today for a free consultation.