They may be allowed to return to the drug industry if they substantially assist in the investigations or prosecutions of others in drug-related cases and submit persuasive evidence that they are rehabilitated and are no longer a threat to the drug approval process. So far, no debarments have been terminated. Tamar Nordenberg is a staff writer for FDA Consumer. Act's Other Authorities Mandatory debarment isn't the only authority given to FDA by the Generic Drug Enforcement Act. In January 1997, FDA used this authority for the first time, debarring the head of a blood plasma facility convicted of falsifying blood records.
Firms are also subject to mandatory or permissive debarment.
They can be debarred for up to 10 years, depending on the seriousness of the crime and other factors, and they can be debarred permanently if they are convicted a second time while debarred. FDA can suspend marketing of some or all of a company's drug products if the company is under investigation for certain conduct that may influence the safety or effectiveness of a drug. For a generic drug that's already been approved, FDA may withdraw that approval if the company used bribery or fraud to get approval or if the company can't produce the drug properly.