Special Counsel raises questions about FDA’s biologics inspections

In closing a whistleblower case concerning allegations of downgraded inspection findings raised by a former investigator on the US Food and Drug Administration’s (FDA) Team Biologics, US Special Counsel Henry Kerner wrote to President Joe Biden that he is “troubled” by many aspects of the case.

In the letter, Kerner says that FDA’s report on its investigation of the allegations “meets all the statutory requirements but that the findings do not appear reasonable” and urges the agency “to closely examine compliance matters like these where inspectors identified serious compliance concerns, but where the agency reclassified their findings after significant time had elapsed.”