Recently, Gus Eyler, Department of Justice (DOJ) Consumer Protection Branch Director, commented at the November 2020 Health Care Compliance Association Virtual Healthcare Enforcement Conference that clinical trial fraud was a “key area of drug and device related enforcement” in recognition of the heightened importance of research during the disruptions associated with the COVID-19 pandemic. The principal DOJ entity responsible for enforcing the Federal Food, Drug & Cosmetic Act (FDCA) against life sciences-based organizations, recent comments by the director are notable, reported prominent law firm King & Spalding, as this consumer protection branch has not only tripled in size but has also obtained over $12 billion in fines, forfeiture and penalties in just the last two years. Some notable recent cases highlight the growing enforcement vigilance in this important clinical research sector. For example, a Florida-based study director at Miami’s Unlimited Medical Research will be going to jail. Lisett Raventos pled guilty to defrauding an “unnamed” pharmaceutical company sponsor. Meanwhile, a contract research organization (CRO) as well as principal investigator have been incited by a grand jury in Ohio for defrauding up to eight pharmaceutical sponsors.
Recently in JD Supra a piece authored members of the FDA and Life Sciences practice of King & Paulding highlighted some recently disturbing instances where rogue principal investigators and CROs were out to defraud pharmaceutical sponsors.
They also happen to endanger patients and threaten the integrity of research. Pharmaceutical sponsors must vet investigators and CROs carefully. TrialSite reminds of the Sami Anwar case where a in Washington State a rogue investigator stole nearly $6 million from pharmaceutical companies. Few industry media covered that case.
South Florida: A Beautiful Place, Great Health Systems & Many Small Trial Site Organizations
With several million people residing in this part of Florida, a highly diversified population, including Hispanics, the elderly and other ethnic groups make this region a strategic location for a diversified pool of study participants. Helping, of course, are the world class academic medical centers and health systems and their research divisions, a number of non-profit focused research institutes and many small, privately owned trial site organizations.
South Florida has had a few clinical research sites with questionable intent over the last decade. From time to time, medical professionals have been known to set up operations there to engage sponsors and CROs to conduct clinical trials marketing access to the Hispanic communities there, for example. Of course, in the overwhelming cases these are honorable, hard-working and ethical and moral professionals. But in some cases, the pursuit of money supersedes patient safety and study quality.
Pediatric Asthma Clinical Trial Tainted
A case in point in the recent guilty plea by Ms. Lisett Raventos. In United States vs. Raventos et al., No. 20-20190 (S.D. Fla. 2020) this Florida resident pled guilty to conspiring to falsify clinical trials data. As published by the Department of Justice last month, a unnamed pharmaceutical company was defrauded by Ms. Raventos of Unlimited Medical Research. The crime of conspiracy to commit wire fraud involved the site directors activity from 2013 to 2016 and a scheme to fabricate the data and participation of subjects in a clinical trial. The defendant admitted that she falsified medical records to make it appear as though pediatric subjects made scheduled visits to the trial site organization; that they took the drugs per the protocol. Of course, the trial site received the payment.
In the DOJ press release, U.S. Attorney for the Southern District of Florida, Ariana Fajardo Orshan commented, “Fraud in the conduct of clinical trials is simply unacceptable, especially where the drug under investigation was meant to serve children and other vulnerable populations.” Fajardo Orshan thanked the FDA’s Office of Clinical Investigations, Miami Field Office, for helping bring down the scheme. The defendant faces up to 20 years in prison.
Ohio Research Indictment Involving Alleged Schemes
Up in Ohio this summer, more trouble was brewing as a grand jury there moved to indict a group of defendants in a purported scheme to defraud a total of eight pharmaceutical companies and the FDA. In the United States v. Demming et. al., No. 20-00395 (N.D. Ohio 2020) a group of defendants, from a contract research organization (CRO), including the president of the company as well as a physician who served as the CRO’s principal investigator. Apparently, this rogue CRO was doing business with pharmaceutical companies to conduct studies on their behalf—as CROs do—but in this case, they did so with very bad intentions. To achieve study target commitments, and hence secure payment, this potentially illicit CRO and principal investigator actually enrolled subjects under faked names while making up records to support the scheme involving an investigation into the safety, efficacy and pharmacokinetics associated with select investigational therapies involving iron deficiency, influenza and asthma. TrialSite will monitor this situation.
As noted in JD Supra by the attorney authors from King & Spalding, the FDA runs the Bioresearch Monitoring Program (BIMO) which executes domestic and foreign inspections of FDA-regulated clinical research of investigational drugs, medical devices and biological products. Per King & Spalding: “FDA conducts BIMO inspections routinely as part of the process for approving marketing applications, and in response to adverse events, complaints, and whistleblower allegations. These inspections are intended to (1) protect the rights, safety and welfare of human subjects, (2) verify the integrity—accuracy and reliability—of clinical trial data submitted to FDA in support of research or marketing applications, and (3) ensure compliance with FDA laws and regulations applicable to clinical research.”
FDA conducts ongoing inspections of investigators, institutional review boards (ethics committees or IRBs) and sponsors but also executes routine and “for cause” inspections of CROs.
For more information about FDA actions and enforcement points, follow the link to the JD Supra piece authored by Mark Brown, Ethan Davis, Mark Jensen and Beverly Lorell, MD or check out the FDA’s website.