As a healthcare business owner, staying compliant with regulatory requirements is essential to the success and positive reputation of your business. One primary aspect of compliance is ensuring you are checking the FDA debarment list to verify that those involved in your operations are not debarred by the FDA.
What is FDA Debarment?
Debarment prohibits, or bars, individuals and entities from drug application submission and related activities. The federal Food and Drug Administration (FDA) is required by law to debar individuals who have been convicted of (1) a felony relating to the development or approval of any drug product, or (2) other conduct otherwise relating to the regulation of any drug product under the federal Food, Drug, and Cosmetic Act (FD&C Act).
Is FDA Debarment the Same Thing as Exclusion?
Debarment should not be confused with exclusion. Exclusion is something imposed by the HHS Office of Inspector General (OIG). OIG may exclude individuals from participating in federally funded healthcare programs (e.g., Medicare, Medicaid, Tricare). Individuals who are excluded are prohibited from receiving payment for items or services that they furnish. The statutory (legal authority) for exclusion is the Social Security Act. Some exclusions are mandatory (e.g., these exclusions must be imposed), while others are permissive.
For How Long Can an Entity or Individual be Debarred?
Certain offenses result in mandatory debarment for a period of between 1 to 10 years, while other offenses result in permanent mandatory debarment. Permissive debarment may last for up to five years.
What is the FDA Debarment List?
The names of debarred individuals and entities are published in a list, known as the FDA debarment list. The federal government updates this publicly available list at least quarterly. The effective debarment date and minimum debarment period are displayed for individuals on the list.
What are Debarment Penalties?
Debarred individuals who, during the period of debarment, provided services to people who had an approved or pending drug product application, are subject to fines of up to $250,000.
Individuals who have an approved or pending drug patent application, who knowingly employed or retained, or used the services of, a debarred individual, are subject to fines of up to $250,000.
What are Debarment Certifications?
Any application for approval of a drug product must include a certification that the applicant did not and will not use in any capacity, the services of a debarred person in connection with the application. Applicants should therefore frequently check the FDA debarment list to ensure their certifications are accurate.
Checking the FDA Debarment List Using Compliancy Group Software
Compliancy Group’s healthcare compliance solution software, The Guard, contains a built-in Exclusion Module that allows you to automatically conduct FDA debarment list checks. Conducting these checks allows healthcare organizations to identify debarred individuals, thereby ensuring accurate certifications. Failure to consult the list can lead to inaccurate certifications, which can have negative consequences for a healthcare organization and its reputation.
The Guard also allows you to conduct LEIE OIG Exclusion list checks, GSA SAM exclusion list checks, and state exclusion list checks – all in one convenient module.
Leverage Technology to Complement an FDA Debarment Check
By leveraging technology and industry best practices, healthcare business owners can enhance their regulatory compliance efforts, prevent risky incidents within the hiring process, and mitigate potential cases of non-compliance.
To approach the identification of those that fall within the FDA debarment list of clinical investigators, start prioritizing a software solution built to protect your operations and the reputation of your practice.
