FDA Increasing Focus on Data Integrity Issues

The FDA is increasingly focusing on data integrity issues, including data manipulation, when conducting preapproval facility inspections, according to industry attorney Fredrick Branding, a partner with Reed Smith.

Concerns over data integrity issues have resulted in the agency adding 10 companies to the for-cause inspection list, Branding said, and the FDA has found questionable data during three out of 10 for-cause inspections. “It strikes me as being a somewhat significant number of firms,” Branding said during an FDAnews audioconference.

The FDA is noticing some electronic data manipulation in parts of its preapproval inspection program and is focusing on training its investigators to be more alert to data manipulation, Branding said.

“That harkens back to the time of the generic drug scandal when there were just flat out substitution of products, actual drylabbing [fabricating scientific evidence] … in laboratory notebooks … and wholesale substitution of data and information,” Branding said.

Agency inspectors will be looking at inconsistencies or discrepancies that raise questions regarding the validity of records and data, as well as questioning whether preapproval batches are GMP compliant and if unfavorable tests results were recorded, Branding said.

The audioconference, “Preparing for an FDA Preapproval Inspection,” can be accessed at www.fdanews.com/conference/detail?eventId=1012.