The process of debarment began after the generic drug scandal in the late 1980s and the FDA continues to use this process to preclude individuals from participating in a variety of activities, including drug development, manufacture, clinical studies in support of drug applications, and importing drugs into this country if they are have been convicted of a crime associated with those activities. Most of the original debarments related to falsification of data submitted in drug applications or manufacturing activities and providing false information to the FDA. To date, there have been 150 debarments for activities related to drug applications and 59 debarments related to other non-application-related offenses.
Debarment is a tool that the FDA has to deter bad behavior, and its scope has been expanded ever since the generic drug scandal. Some of the more recent activities that have been cited in Federal Register Notices for persons debarred include:
- Falsification of lab results in clinical studies
- Not performing the physical examinations that were recorded as being completed
- Changing lab results
- Importing unapproved drugs into the United States
- Distributing misbranded and adulterated drugs
- Conspiracy with drug traffickers to distribute misbranded and counterfeit cough syrup
- Falsifying medical records and data to admit dozens of ineligible research subjects
- Falsifying research data vital signs
- Directing patients to dispose of study medications and then falsely record dispensing as required by the study
- Falsification of drug manufacturing records
- Falsification of stability data
Unfortunately the list goes on and on. A list of debarred individuals who have been debarred related to drug applications can be found here. The site also includes a link to a listing of persons previously debarred (expired debarment list). There have been thirteen debarments in 2024 and 2025 to date.
Debarments can occur up to five years after the criminal behavior has occurred. Debarment can be permanent or permissive, lasting from two to ten years, depending on the seriousness and pervasiveness of the crime and behavior. So when we speak of data integrity or a criminal behavior using mail fraud, etc., the result can be debarment. As people continue to defraud the system, expect that debarments will continue. Why? If there is money to be made, people will still choose fraud and bad behavior to try to game the system. Keeping vigilant is the only way to root out bad behavior and the process of debarment does offer a deterrent.
