CEO of Novartis pledges to speed data integrity disclosures
Novartis reportedly knew of discrepancies in the Zolgensma data it had submitted to the FDA but delayed informing regulators so has announced alterations to its processes.
Vas Narasimhan, Chief Executive of Novartis is facing backlash over data manipulation involving $2.1 million gene therapy Zolgensma and has pledged to tell regulators quickly if credible questions emerge in future over data integrity, reports Reuters.
It has been reported that Novartis knew of discrepancies in the Zolgensma data it submitted to the US Food and Drug Administration (FDA) before it won approval in May, but delayed informing regulators until June while it completed an internal investigation.
While the FDA has concluded Zolgensma is safe and effective and should remain on the market, it has been reported that the US drug watchdog raised questions about the timing of Novartis’s disclosure.
“We are making a voluntary commitment to notify the FDA within five business days of receipt by our quality (control) organisation of any credible allegation related to data integrity impacting any pending application in the Novartis Group,” Narasimhan said at an investor event, adding the company will take a similar approach in other jurisdictions.
Novartis said it gave “detailed explanations” on 23 August to the FDA about the company’s investigation into the data manipulation and addressed regulators’ questions over why the company waited until late June to make disclosures, said the report.
“What we realised through this situation is, during a filing, it’s difficult for us to exercise that judgment without it being later considered maybe not the best judgment,” Narasimhan said. “So we’re just taking judgment out of that equation.”