STAT Plus: An FDA report reveals the agency believed Novartis data problems were resolved months ago
Shortly before serious data problems surfaced in mid-March at a troubled Novartis (NVS) unit, a Food and Drug Administration report noted the company had recently conducted an “extensive investigation” after finding errors and discrepancies in a preclinical test. The agency apparently believed the difficulties had been rectified.
In a February 2019 report, FDA personnel noted that AveXis — the Novartis unit at the center of a scandal over manipulating data for the gene therapy — uncovered problems with a so-called mouse assay. The discovery occurred in October 2018, although the FDA team wrote they were “already aware” of the issues with the test and had run an independent analysis of corrected data the company submitted to the agency.
