Health Providers DB includes the Food and Drug Administration (FDA) Debarment List, updated monthly.
Avoid potential Civil Monetary Penalties (CMP) by automating the monitoring of your employees and vendors against the HHS-OIG LEIE, GSA-SAM, and all State Medicaid Exclusion Lists, as well as the FDA Clinical Investigators—Disqualification Proceedings and FDA Debarment Lists.
The FDA Debarment List includes individuals and entities debarred or sanctioned for abuse, fraud, or integrity issues under sections 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act 21 U.S. Code §335a — Debarment, temporary denial of approval, and suspension or 21 U.S. Code §335b — Civil penalties as published in the Federal Register.
Healthcare organizations must screen new hires and regularly monitor current employees, as well as individuals and entities they do business with, to avoid potential Civil Monetary Penalties.
About the FDA Debarment List
The FDA Debarment List records individuals and companies prohibited from providing services, participating in transactions, or conducting general business with the U.S. Food and Drug Administration for conduct by:
- A firm relating to the development or approval, including the process for development or approval, of any abbreviated drug application or,
- An individual convicted for developing or approving any drug product or otherwise relating to any drug product under the Federal Food, Drug, and Cosmetic Act.
This list aims to help businesses comply with FDA regulations and safeguard public health. It does this by preventing those with a history of regulatory non-compliance from engaging in FDA-related activities altogether.
The FDA Debarment List is compiled per 21 U.S. Code §335a(e) from notices published in the FEDERAL REGISTER (FR).
For healthcare businesses, associating with a debarred individual or firm can have various consequences. These consequences often range from legal repercussions to monetary losses, reputational damages, and contract terminations.
One of the simplest ways to mitigate the risk of these events is to do an FDA debarment list search. Compliance officers should implement this check as part of their company’s internal vetting processes. Conducting an FDA debarment list search should consist of a few things.
The first step is to immediately halt any ongoing contracts with the individual or vendor found after completing an FDA debarment list check. Compliance officers also have to consider that the debarment list is meant to prevent companies from hiring someone who is banned from working within the drug industry unknowingly or accidentally.
Once the observation is made, an organization should report the discovery immediately, as hiring someone on the FDA debarment list can cost upwards of Fines to reach levels of $250K per individual and $1M per organization in penalties.
In some cases, you may be required to report your findings to regulatory authorities. This is especially true if your organization has checked the FDA debarment list of clinical investigators and unknowingly continues to work with a debarred person. In this case, the FDA’s Office of Criminal Investigation will likely further investigate the violation.
The FDA Debarment List Data Collected
The Health Providers DB includes the following details of the FDA Debarment List. Links to the Debarment Order are provided for reference and research.
https://www.fda.gov/media/147870/download?attachment
The FDA Debarment Data Dictionary
| Field Name | Description |
|---|---|
| Last Name | Person last name |
| First & Middle Names | Person’s first name and middle name |
| Effective Date | The effective date |
| End/Term of Debarment | The debarment term |
| Volume Page.pdf | Link to the Debarment Order PDF |