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.
Given the stakes during this pandemic, this move in the US is welcome. Nevertheless, at any time, we need our watchdogs to be vigilant for fraud in clinical trials – as lives are at stake.
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
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).
