Preventing a clinical trial from turning into a criminal trial – Healthcare

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On November 2, 2022, Stacy Cline Amin, former Chief Counsel for the United States Food and Drug Administration (FDA) and Assistant General Counsel for the Department of Health and Human Services (HHS), moderated the panel “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement,” at the Food and Drug Law Institute conference Clinical Trials: Deconstructing the Challenges and Providing Practical Information Conference. The panel included a senior attorney from the Consumer Protection Branch (CPB) of the Department of Justice (DOJ) and other regulatory compliance officials to discuss trends and key issues in the enforcement of trials clinics who have highlighted the need to ensure that appropriate compliance measures are in place to avoid future investigations.

Key takeaways regarding the trajectory of clinical trial fraud investigations and enforcement actions include:

  • Objectives of Investigations and Prosecutions

    One of the most notable comments from the panel was the confirmation that the DOJ not only reviews the activity of individuals (e.g., owners or managers of clinical trial sites), but also large players in the company (e.g. sponsors or CROs), with special emphasis. on the submission of false and misleading data to the FDA and the obstruction of the FDA and other regulators. The DOJ is also looking at cases where investigator-level data may be honest and accurate, but where sponsors may have decided to shape it in a certain way or omit information – which can be exacerbated in a biotech environment, where start-ups may be under pressure to show results for the next round of funding. The DOJ is also very alert to bad actors whose activities may expose clinical trial participants to harm, such as a clinical trial intentionally providing an experimental treatment to a patient whom it knows is not qualified to participate in the study.


  • Billing Mechanisms – Using the Drugs and Cosmetics Act (FDCA)

    Historically, the DOJ has used traditional criminal tools like wire fraud and obstruction to prosecute criminal activity in this space. Recently, the DOJ has tended to consider also pursuing cases under the FDCA, including criminal felony or misdemeanor actions, since sponsors are responsible for overseeing investigations, meeting reporting requirements for trials clinics and keeping accurate records. An example is charging for application fraud. However, the DOJ also advised that even if they choose not to sue under the FDCA, such violations may bolster other criminal charges they may pursue, such as conspiracy under Title 18. It was also noted that the DOJ is considering whether it should more frequently exercise its enforcement discretion, both civil and criminal, for the failure of a responsible party to register a clinical trial and submit the results on clinicaltrials.gov. As for other actions, the DOJ noted that it plans to bring criminal actions for money laundering and identity theft, as well as civil actions under the False Claims Act.


  • The Influence of FDA Inspection Classification on DOJ Actions

    The DOJ has made it clear that the FDA inspection classification is not determinative of whether the DOJ will take action. While the DOJ noted that the FDA’s inspection classification is informative, it also noted that the DOJ’s inspection and investigation tools differ from those of the FDA. DOJ tools, such as search warrants, are designed to unearth criminal activity. Indeed, the DOJ further noted that a fraudulent actor may misrepresent their activities to the FDA during an inspection, meaning that a glowing inspection classification may be just one more incident. clinical trial fraud.


  • Special attention to cybersecurity and digital registration

    With the advent of digitization of clinical trial processes due to COVID-19, clinical trial sites have intrinsically linked digital operations to their business models. However, the speed of integration of these digital tools may not match the compliance mechanisms needed to ensure subject and data integrity. In the clinical trial timeline, there are four key digital concerns that industry must address to ensure compliance.


    • Find the participant: Certain patient populations are at a premium, especially if a treatment targets a rare disease. Although the use of digital technologies can greatly increase the ability to locate appropriate participants, digital hiccups do occur and the system must have appropriate confirmation tools to ensure that the participant is appropriate for the study.

    • Participant registration: Once a suitable participant is found, they must consent to the study. Electronic informed consent is completely acceptable, but only if executed correctly. An example of a potential misstep is if the patient experiences connectivity issues while a healthcare provider is explaining what the study entails. In such a situation, the patient’s consent may not be truly informed, so telemedicine engagements should contain protocols to ensure that the participant is able to engage fully and knowingly with the provider. Health care.

    • Securing participant data:Entrant health data may be subject to HIPAA and other privacy and electronic security requirements. Clinical trials should design their digital databases to comply with appropriate security and privacy protocols and ensure that employees are trained in the use of these systems.Reporting health information and results: In the context of larger clinical trials, the use of inaccurate or misleading algorithms to self-report or synthesize health information may expose the trial to liability for fraud, waste and abuse. This highlights the important need to manage the risks with the benefits of using digital technologies in clinical trials.

  • What Sponsors and Other Business Actors Can Do to Mitigate DOJ Enforcement Risks

    The DOJ places great importance on whether sponsors have implemented and maintained an effective compliance program, which typically includes training, procedures, and auditing mechanisms used by sponsors in this space. Specifically, the DOJ considers sponsor monitoring and communication flow with CROs, escalation procedures and whether they were followed, what questions were asked, whether documentation or records are accessible to the sponsor, whether there was self-reporting to the FDA, and in some cases, if there was self-reporting to the DOJ. These factors underscore the need for sponsors to exercise meaningful due diligence and proactively monitor and audit potential clinical investigators and CROs.

MoFo’s FDA + Healthcare Regulatory and Compliance practice works seamlessly with our Investigations + White Collar Defense, Global Ethics + Compliance, Life Sciences Transactions + Licensing, and Privacy + Data Security practice groups to ensure that life sciences companies remain compliant with all federal and state requirements. . Please subscribe and follow our life sciences blog as we continue to update the industry on new compliance developments.

Due to the generality of this update, the information provided here may not be applicable in all situations and should not be applied without specific legal advice based on particular situations.

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