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.

The mechanism is blunt on purpose. A debarred individual may not provide services in any capacity to a person with an approved or pending drug application.

What triggers it

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.

This is the part with practical consequence. The certification is a statement to FDA, and it obliges you to actually know. That means checking:

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

FDA publishes the debarment list, and screening against it is a routine control most quality systems own.

The related lists

Debarment is one of several exclusions, and they are frequently confused.

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 programmes. Broader, different authority, and relevant to your commercial organisation more than your regulatory one.

SAM.gov exclusions. Federal contracting.

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

Why it matters beyond compliance

Using a debarred person can invalidate an application, and it puts the certification you signed into question, which makes it a data integrity problem rather than an administrative one.

For a company acquiring products or bringing on a new CRO, the diligence question is straightforward and worth asking early.