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After Scandal, Novartis Pledges Faster Action on Data Integrity

Working to regain trust after a damaging scandal, Novartis CEO Vas Narasimhan on Monday pledged to more quickly inform U.S. regulators of any data integrity issues which crop up in the future for drugs the company submits for approval.Speaking at an event discussing Novartis governance, Narasimhan revealed the Swiss pharma has committed to tell the Food and Drug Administration within five business days of any credible allegations related to data integrity questions with any pending drug application. Novartis made that pledge in an Aug. 23 response to an inspection report issued by the agency after revelations the company’s application for its gene therapy Zolgensma contained manipulated data. The drugmaker waited until after Zolgensma won approval to inform the FDA — a decision that provoked a sharp rebuke from the regulator and widespread scrutiny of Novartis’ decisionmaking.

Dive Insight:

A month since disclosure of the data manipulation, Novartis and CEO Narasimhan remain under scrutiny for their handling of a scandal that’s marred the landmark approval won for Zolgensma (onasemnogene abeparvovec) in late May.

Novartis first learned of the altered data two months before the FDA’s decision, but waited until completing its technical evaluation to inform the agency on June 28.

Narasimhan and other company executives have defended that choice, saying at no point did Novartis believe the issues — involving preclinical mouse data — put into doubt Zolgensma’s safety or efficacy.

The FDA agrees on that point and has said the treatment should remain on the market. But the agency indicated it would have delayed its approval had it known of the manipulation beforehand. An investigation into Novartis remains ongoing, and could result in civil or criminal penalties against AveXis, the biotech developer of Zolgensma that Novartis bought for $8.7 billion last year.

Novartis’ new commitment is part of its response to FDA concerns, and appears an acknowledgement of criticism on the company’s faced on the timing of its disclosure.

“When there’s not an impact on product safety or product quality, it’s our judgment on how best to manage the situation,” Narasimhan told investors at the Monday event.

“During a filing, it’s difficult for us to exercise that judgment without it being later considered maybe not the best judgment,” Narasimhan later added. “So we’re just taking judgment out of the question during a file.”

That said, Novartis caveated its commitment as pertaining to any “credible allegation” of data integrity issues that involve a pending application. According to Narasimhan, Novartis spent 39 working days to confirm the allegations involving Zolgensma, after which the company took another 35 working days to complete its quality investigation.

It’s not clear how the FDA would receive such a commitment. Novartis said the public disclosure of its response to the agency, which included “detailed explanations” and addressed other questions, would be up to the regulator. The FDA was unavailable to comment.