FDA Debarment: The Certification in Every Application

Debarment bars an individual or company from participating in the drug approval process. It comes from the Generic Drug Enforcement Act of 1992, passed after a bribery and data falsification scandal in generic drug approvals, and it sits in section 306 of the FD&C Act.

A debarred individual may not provide services in any capacity to a person with an approved or pending drug application.

Grounds for debarment

Mandatory debarment for an individual convicted of a felony relating to the development, approval or regulation of a drug product.

Permissive debarment where FDA finds conduct that undermines the integrity of the process, including a misdemeanour conviction relating to drug regulation, or a felony relating to the drug industry more broadly.

Companies can be debarred too, where a conviction relates to the development or approval of an application.

The certification you sign

Every ANDA, and NDAs and BLAs through related provisions, carries a debarment certification: a statement that you did not and will not use, in any capacity, the services of a debarred person in connection with the application.

Signing it obliges you to know, which means checking:

• Employees working on the application.
• Consultants and contractors, including regulatory consultants and medical writers.
• CROs and CDMOs, and their staff on your work.
• Clinical investigators.

FDA publishes the debarment list, and the screening runs against it.

The related lists

Debarment is one of several exclusion lists.

FDA Debarment List. Section 306, drug approval process.

FDA Disqualified and Restricted clinical investigators. Investigators FDA has found repeatedly or deliberately non-compliant, or who submitted false information. Separate from debarment.

HHS OIG Exclusion List (LEIE). Exclusion from federal healthcare programs. Broader, different authority, and relevant to your commercial organization more than your regulatory one.

SAM.gov exclusions. Federal contracting.

A screening program that checks only one of these has a gap.

Consequences

Using a debarred person can invalidate an application and calls into question the certification you signed. A company acquiring products or bringing on a new CRO should screen during diligence.