Background: Clinical Research Trials are a Pivotal Part of the FDA’s Drug-Approval Process
To obtain Food and Drug Administration (“FDA”) approval for new drugs and medical devices, manufacturers — also known as “sponsors” — must prove that a proposed new product is safe for human consumption or use. To do so, sponsors conduct clinical trials that test the product on human beings, and submit data from such trials to the FDA.2 After obtaining the FDA’s go-ahead to begin clinical trials, sponsors typically hire (either directly or indirectly via contract research organizations) individual research laboratories known as “investigators” to actually conduct the trials. In entering into this agreement, investigators must agree to comply with all FDA regulations.3 However, the sponsor is responsible at all times for monitoring clinical investigations and must ensure their investigators’ compliance.4 Ultimately, data from clinical research trials 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 (including clinical research data) can be grounds for the FDA withholding or withdrawing its approval of a new drug, and can also be the basis for civil and criminal enforcement actions against the sponsor, contract research organization, or investigator.5
A Major Concern: the DOJ’s Enforcement of Clinical Trial Fraud
Clinical trial fraud cases typically begin with an investigation by the FDA’s Office of Criminal Investigations, and are ultimately prosecuted by the DOJ — usually the CPB or the Health Care Fraud Unit.6 These investigations are complex and typically take years before reaching a conclusion. Historically, however, there have not been many prosecutions for misconduct regarding clinical research data.
This has begun to change. Enforcement leaders at the DOJ’s CPB have been vocal about the need to focus enforcement on fraud in clinical trials. In late 2019, even before the start of the COVID-19 pandemic, Director Eyler warned of “real risks” to consumers “if a drug or device approval is founded on manipulated or just downright falsified data.”7 And in December 2020, after the global pandemic placed worldwide intense scrutiny on the drug trials of potential vaccines, Deputy Attorney General Daniel Feith stated that “safeguarding public trust in the [drug and device] approval process has never been more important than it is today” and stressed that the CPB is “aggressively investigating and prosecuting misconduct ranging from falsifying and altering trial results and other data” to “making misrepresentations” in FDA approval submissions.8
A Flurry of Activity: Multiple Prosecutions in Quick Succession Starting in Late 2020
DOJ’s focus on clinical research fraud has resulted in increased enforcement activity in 2020 and early this year. For instance, on August 31, 2020, the CPB charged investigators in Florida with conspiracy to commit wire fraud and making false statements for allegedly falsifying research data in connection with clinical trials of an experimental medication meant to treat children with asthma.9 By early February 2021, three of the four defendants in this case have pleaded guilty and one defendant has been sentenced to 30 months in prison and ordered to pay over $400,000 in restitution.10 Weeks later, the CPB brought similar charges in a separate prosecution against a doctor and other members of a Miami clinical research laboratory, alleging that defendants invented clinical research data (including subject information and lab results) pertaining to trials for several experimental drugs.11 And, DOJ’s Health Care Fraud Unit, as part of its 2020 National Health Care Fraud and Opioid Takedown Operation, recently brought a 19-count indictment charging employees of a contract research organization and research laboratory with falsifying information regarding study subjects, medical records, and other clinical research data in connection with trials for eight different pharmaceutical companies.
Deputy AG Feith cautioned that the CPB expects to announce even more clinical trial fraud prosecutions soon.12 Urging self-disclosures, Feith warned stakeholders to “report promptly any research misconduct to federal regulators whenever it is discovered,” and suggested that diligent reporting may allow sponsors and others to avoid “enforcement consequences.”13
DOJ’s recent focus on curbing fraud in clinical research trials serves as a warning to sponsors, contract research organizations, and investigators to have robust compliance programs in place to prevent or identify misconduct. In addition to myriad clinical trials for new medications and medical devices treating any number of health conditions, there are currently over 3,000 pending clinical research studies related to COVID-19. Given the DOJ’s intense focus on fraud relating to the COVID-19 pandemic, it is likely that DOJ will heavily scrutinize any reported irregularities in clinical research data and investigate any suspected fraud in clinical research trial data for treatments of COVID-19. In the meantime, sponsors, clinical research organizations, and investigators alike should carefully assess due diligence procedures, compliance programs, and reporting mechanisms in order to reduce their exposure to criminal or civil liability as DOJ’s remarks suggest that cooperation credit may be significantly hampered if companies fail to self-disclose misconduct.
1 Gustav Eyler, Dir. Consumer Prot. Branch, Dep’t of Justice, Remarks at the Food and Drug Law Institute’s Advertising and Promotion Conference (Oct. 18, 2019).
2 21 C.F.R. §§ 312.20–312.23.
3 Food & Drug Admin., Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs (May 2010).
4 21 C.F.R. § 312.56.
5 21. C.F.R. § 314.150; 21 U.S.C. § 331(jj) (authorizing civil penalties); 18 U.S.C. § 1001(a)(2) (criminal liability for false statements to government officials); 18 U.S.C. §§ 1341, 1343 (criminal mail and wire fraud); 21 U.S.C. § 331 (failure to establish and maintain accurate clinical records); 18 U.S.C. § 1347 (health care fraud).
6 Dep’t of Health & Human Servs. and Dep’t of Justice, Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2019 (June 2020).
7 Supra note 1.
8 Daniel Feith, Deputy Att’y Gen., Dep’t of Justice, Remarks at the FDLI Enforcement, Litigation, and Compliance Conference (Dec. 15, 2020).
9 United States v. Bencosme, 20-cr-20190 (S.D. Fla. filed Aug. 31, 2020).
11 Indictment, United States v. Valdes, No. 21-crs-20106 (S.D. Fla. filed Feb. 23, 2021).
12 Supra note 8.