Special Termination of Debarment for One FDA Reviewer is Granted

In a Federal Register Notice today, the FDA announced the termination of permanent debarment of David Brancato.  David was one of the original FDA staff members implicated in the Generic Drug scandal.  He was originally debarred on January 6, 1994.

Special termination of debarment can occur when there is a determination that an individual substantially assisted in and cooperated with authorities in the investigation.  In addition, the FDA must determine that the termination of permanent debarment is in the interest of justice.  Finally, the person must have served at least 1 year of debarment before termination can be considered.  It has been over 21 years since his debarment.  Although, according to the Federal Register notice, Dr. Brancato applied for termination of his debarment in 1998; the lifting of his status comes after the FDA asked for additional information in April 2015.  The notice describes his cooperation, and the reasons FDA believes that the termination is in the interest of Justice.

The Federal Register notice can be found here.  https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-17712.pdf If my memory serves me correctly, David is the first of the original FDAers implicated in the generic drug scandal to have his debarment terminated.