Novartis Makes New Commitment to Data Integrity

September 16, 2019

Novartis CEO Vas Narasimah promised investors in a briefing that the drugmaker will report any credible data integrity concerns to the FDA within five days of receiving them, in the wake of the data manipulation scandal surrounding its gene therapy Zolgensma.

Narasimah said the company made the commitment to the agency voluntarily because it has learned that, when such issues arise, “it’s difficult to exercise the best judgement” to stay in compliance with FDA regulations.

The company made the commitment in its response to an Aug. 2 inspection report issued to its subsidiary AveXis. The inspection revealed possible data problems at AveXis going back almost two years, including observations that multiple animal testing data discrepancies were not properly investigated.

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