While speaking at the Food & Drug Law Institute’s Enforcement, Litigation and Compliance Conference in December, Assistant Deputy Attorney General Arun Rao identified clinical trial fraud as one of the four main areas of law enforcement by the Consumer Protection Branch of the United States Department of Justice (“DOJ”).1 Rao warned of the “dangerous consequences” of research fraud (often referred to as “research misconduct”), which he says serves to “undermine trust in the healthcare industry as a whole.” .
Rao’s remarks come at a time of growing focus on scientific misconduct in clinical trials. Rao cited two recent clinical trial fraud enforcement actions in South Florida that involved allegedly fabricated data, and he suggested that further enforcement actions may be in the works.
The COVID-19 pandemic will likely intensify these enforcement efforts. The Food and Drug Administration (“FDA”) and other agencies (including the National Institutes of Health (“NIH”) and the Office for Human Research Protections) have issued guidance on the conduct of clinical trials during the pandemic of COVID-19 to assist sponsors in ensuring the safety of trial participants, maintaining compliance with good clinical practice (“GCP”), and minimizing risk to trial integrity. Significant government funding for clinical trials and basic science research during the pandemic will only increase regulators’ interest in investigating allegations of potential data integrity issues. Therefore, all organizations involved in basic science research, and in particular clinical trials, should seek to identify and address key areas of application risk.
Areas of Legal Risk Related to Clinical Trials
Scientific misconduct in clinical trials raises a number of risks, including criminal prosecution, enforcement of FDA regulations, and False Claims Act liability, in addition to reputational damage.
The Department of Health and Human Services (“HHS”), Office of Research Integrity (“ORI”) defines research fraud and misconduct as “fabrication, falsification, or plagiarism in the proposal, performance, or review of research, or in the communication of research results”.2 This definition would potentially include reporting false, fabricated, or misleading data, failing to disclose data that would normally be reported, submitting misleading reports regarding the conduct of the trial, and submitting false data to government agencies and /or for publication in journals. In addition to fraud, other areas of investigative risk include foreign influence, conflict of interest, and bribery, both foreign and domestic. Although the ORI only has jurisdiction over HHS-funded research, the concept of research misconduct is well known to other parts of HHS and the federal government, including the FDA. Additionally, the receipt by many companies during COVID of federal drug development funds means that ORI’s jurisdiction may, in many cases for the first time, extend to these science-based companies.
Foreign influence cases typically arise when an investigator uses U.S. federal funds for research while maintaining undisclosed affiliations with other international institutions or universities, or when investigators within commercial entities have undisclosed former U.S. affiliations that cause them to share their employer’s technology without permission. The DOJ views these undisclosed relationships as problematic because they can potentially lead investigators to “double-cross” receiving federal and foreign funds, as well as transferring US and corporate-funded proprietary information to foreign institutions. Americans. The DOJ has increased its focus on foreign influence cases in recent years, including through the launch of its China Initiative in 2018 to combat economic espionage and the theft of trade secrets by agents or agents of the Republic. popular in China.
Although organizations are often familiar with professional standards regarding conflicts of interest, these conflicts can also give rise to governmental actions. The Financial Disclosure by Clinical Investigators regulation (21 CFR § 54) requires commercial applicants who submit marketing applications for drugs, biologics or devices to submit information on various factors related to compensation and personal financial interests of investigators. It is important that clinical trial sponsors, research institutions, and their investigators identify and disclose personal and financial conflicts of interest in accordance with FDA Part 54 regulations. Failure to do so may represent, among other things, providing false information to federal authorities.
Potential bribes involving exchanges of value for researchers and research institutions may also lead to enforcement action under the Anti-Kickback Act (“AKS”) or the Foreign Corrupt Practices Act (” FCPA”). The AKS prohibits offering or accepting financial compensation or other benefits in exchange for referral services or devices covered by a federal health care program. The FCPA also prohibits improper payments to foreign government officials, which may include individuals affiliated with foreign government-controlled companies, medical centers or universities. Organizations should therefore ensure that they have training, comprehensive accounting policies and procedures, as well as audits, in place to identify and prevent inappropriate payments to researchers, research institutes, trial providers clinics (such as CROs), as well as government officials.
Recent statements from the DOJ make it clear that clinical trial fraud is a priority for the agency, and industrial research sponsors, as well as researchers and research institutions, can expect more enforcement action. in the future. To minimize legal risks, manufacturers should act now to ensure that test sites and investigators have adequate training and procedures, and that these compliance protocols are tested and audited. They must also promptly investigate any potential data integrity issues or other allegations of misconduct in clinical trials or basic scientific research. Please consult your usual Ropes & Gray solicitor for advice on how to minimize your risk.
1. DOJ, “Deputy Assistant Attorney General Arun G. Rao Delivers Remarks at the Food & Drug Law Institute’s (FDLI) 2021 Enforcement, Litigation and Compliance Conference,” (December 9, 2021), https://www.justice. gov/opa/speech/deputy-assistant-attorney-general-arun-g-rao-delivers-remarks-food-drug-law-institute-s.
2. Department of Health and Human Resources Resource Integrity Office, “Definition of Research Misconduct,” https://ori.hhs.gov/definition-research-misconduct.
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