Regulatory Guidance

Top Novartis scientists exited company ahead of data scandal

Aug 14, 2019

More details are emerging about the months leading up to Novartis’s admission that data results for its gene therapy Zolgensma were manipulated.

News of the data issues broke last week when the FDA announced that it plans to take action against Novartis, which admitted that data from an animal study was tampered with before the drug was approved. The FDA said that the findings would not impact its safety assessment of the drug, but if it would have known about the data falsification, it would have delayed approval of Zolgensma.

Novartis had previously stated that was in the process of letting go executives involved in the data manipulation. But in a recent statement, Novartis said that two of the top scientists at AveXis, its gene therapy unit, have not been involved in its operations since May. This latest revelation provides further evidence that Novartis knew about the data problems a full month before it informed the FDA on June 28. Novartis has also said that it is standard procedure to fully investigate internal issues before informing the FDA.

The company has since combined the two jobs of the ousted scientists and hired a new person to fill the role. 

The FDA has threatened Novartis with “civil or criminal penalties.”

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