Looking to slow the fallout from Novartis? data manipulation fiasco with its billion-dollar gene therapy Zolgensma (onasemnogene abeparvovec-xioi), CEO Vasant Narasimhan told an investor conference on Monday that the company will be more proactive in reporting data integrity issues to the FDA.
?We are voluntarily and proactively taking a pledge with the FDA to ensure that we will inform them within five business days of any credible allegation related to data integrity,? Narasimhan said.
He also said Novartis has responded to the FDA?s Form 483?and is making documents available as requested, while reiterating that the data manipulation uncovered at the San Diego site ?does not impact the safety, efficacy or quality of Zolgensma.?
The pledge follows sharp comments made last week by acting FDA Commissioner Ned Sharpless, who did not mention Novartis by name, but clearly singled the company out in his remarks