STAT Plus: FDA closes review of Novartis data integrity scandal without punishing the drug maker
An embarrassing scandal that Novartis (NVS) endured over data integrity has quietly come to a close, with the Food and Drug Administration instructing the drug maker to correct the problem at its AveXis unit, but without imposing any penalties.
At issue was a delay in the disclosing to the agency that manipulated data existed for its Zolgensma gene therapy. Novartis became aware of the problem in March 2019, but did not inform the FDA until after the drug was approved last May. Zolgensma, which costs $2.1 million, is used to treat a type of spinal muscular atrophy and was developed by AveXis, which Novartis bought in April 2018.
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