FDA Inspection of Novartis Lab Raises Questions about Data Falsification

August 19, 2019

A Form 483 issued following an FDA inspection of Novartis subsidiary AveXis’ control testing laboratory — currently the focus of a data manipulation investigation by the agency — is raising concerns about the firm’s own investigation and when it knew about the data discrepancies.

The agency is looking into potentially falsified data the company submitted for Zolgensma (onasemnogene abeparvovec-xioi), a gene replacement therapy for spinal muscular atrophy and the world’s priciest drug, which received the FDA’s approval on May 24. The problematic animal testing data was not brought to the agency’s attention until June 28, nearly a month later, a delay that brought a storm of criticism from multiple parties, including Congress.

The Aug. 2 Form 483 points out possible data manipulation going back nearly two years. For example, a nonconformance report opened on Aug. 23, 2018, reported discrepancies in the data used to calculate relative potency for the gene therapy.

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