The Department of Justice (“DOJ”) has recently announced that it is ramping up its efforts to prosecute fraud in clinical research trials. To obtain Food and Drug Administration (“FDA”) approval for new drugs and medical devices, it must be determined that the proposed new drug or medical device provides benefits that outweigh its known and potential risks for the intended population. To reach such conclusions, those products are subjected to a rigorous process of testing in humans. The data collected through these clinical research trials are then presented to the FDA, which data becomes a key component of a sponsor’s final application for FDA approval of its new drug. False or misleading statements in any part of a final application submitted to the FDA (including clinical research data) can constitute grounds for the FDA to withhold or withdraw its issue of approval of a new drug, and can also be the basis for civil and criminal enforcement actions against the participants in the clinical trial chain including the sponsor, contract research organization, or investigator.
Clinical trial fraud cases typically begin with an investigation by the FDA’s Office of Criminal Investigations, which are then usually referred to the DOJ for prosecution. The DOJ has in recent months been increasingly vocal about its intention to focus enforcement on fraud in clinical trials, noting the severity of potential risks to consumers that may derive from this type of fraud. The DOJ’s increased interest in preventing clinical trial fraud has been further heightened by the COVID-19 pandemic, where the race for a vaccine has placed worldwide intense scrutiny on drug trials. In consideration of the foregoing, Deputy Assistant Attorney General Daniel Feith has urged all stakeholders to avail themselves of self-disclosures, which may allow for mitigated enforcement consequences.
The DOJ’s focus on curbing fraud in clinical research trials serves as a warning to manufacturers, sponsors, contract research organizations, and investigators to ensure compliance with the process, including employing and maintaining robust due diligence procedures, compliance programs, and to ensure appropriate reporting mechanisms are in place to reduce their exposure to criminal or civil liability.
How Frier Levitt Can Help
Frier Levitt acknowledges that complying with federal regulations related to clinical research trials requires tremendous effort and operational precision. Frier Levitt regularly counsels sponsors, contract research organizations, and investigators on the complex legal issues that must be navigated in the clinical research setting and is experienced in submitting and resolving voluntary self disclosures. To obtain a review of an existing or planned clinical research trial, implement an internal compliance program, to submit a self disclosure, or for guidance regarding the process of responding to an investigation, contact us to speak with an attorney.
