You Can Go to Jail for Lying to the FDA (Just in Case, You Did Not Already Know)
(Thursday, May 13, 2021)
Lying to FDA is a federal crime punishable by monetary penalties and jail time. We should never have to say that, but occasionally there are cases of people doing it anyway and becoming a warning for others. The case in point is of a team of clinical operations staff at a Florida CRO that fabricated patient data for a clinical trial sponsored by GSK over three years. The CRO personnel lied to FDA inspectors during an audit of the data. When announcing the charges and the punitive actions, the federal prosecutors did not list any other trials where the perpetrators may also have defrauded the sponsors. It is safe to assume that the other work done by these personnel was reviewed and no issues identified. This was a multi-site clinical trial, and the sponsor was able to replenish the defective data with that from other sites so there was no overall harm to the product. It is very important to remember that these kinds of events are extremely rare; and should not be hyped. This news should not taint the hard working and honest clinical research professionals at CROs. It is likely that the sponsor’s QA team caught on to the fraud and may have reported to the FDA who in turn investigated and found the culprits. The CRO where these people worked seems to have gone out of business, and these culprits would likely never return to the clinical research industry. Often news like these are used by the media to color the entire industry which is unfair. It is important that the clinical research professionals be aware of the details of the event so we can educate others, and use these as examples at training. This event shows that the quality assurance process worked, as expected, and the damage was controlled. Let that be the message that goes out to the populace.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC