In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major concern” for DOJ going into 2020.1 Recent remarks from Deputy Attorney General Daniel Feith, coupled with several recent criminal prosecutions, suggest that increased enforcement relating to misconduct in clinical research trials will be a new focus of DOJ enforcement.
Even outside of a global pandemic, fraud in a clinical trial could cause dire, if not fatal, consequences. At the very least they could see the public receiving treatment that isn’t efficacious. COVID19 has made the stakes much higher and the consequences global. The efforts of the US DOJ should be publicly acknowledged. We have included links to seven related items.
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.
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).
