DI Still a Major Problem – but What’s Being Done About it?

The Association of Accessible Medicines (AAM) meeting in Baltimore this week saw a number of FDA presentations.  One that caught my attention was presented by Sarah Barkow, Ph.D., Acting Director, Manufacturing Quality Guidance and Policy Staff, Office of Manufacturing Quality in CDER.  It had to do with data integrity.

Dr. Barkow noted, “about 40% of OMQ’s warning letters include data integrity lapses.  These letters went to manufacturers around the world.”  That seems to be a rather big indictment of a long running problem, but we have not seen the type of actions that occurred during or after the beginning of the generic drug scandal, with the exception of a very few cases.  Her presentation provided the outline of two case studies, one on deletion of laboratory results with no explanation and the other dealt with a firm that failed to document testing for microbial contamination and sterility.

Dr. Barkow also provided a plan for data remediation.  But my question is that even with data remediation how does one make a distinction between the actions of bad actors vs. a firm that has poor documentation practices?  Is there a threshold that the FDA applies to making the distinction as not to paint all players with the same brush?  Having lived through the generic drug scandal, I know there is a difference between bad documentation vs. outright fraudulent practices.  I just don’t understand where that line is drawn!  That would be a good presentation to see from the FDA.