Novartis CEO pledges to proactively speed up disclosing data integrity issues

Sept. 9, 2019

Novartis CEO Vas Narasimhan reinforced the company's commitment to data integrity after the U.S. Food and Drug Administration recently announced that the drugmaker had manipulated its gene therapy drug application for Zolgensma, which is the world's most expensive medicine.

While the FDA has concluded Zolgensma is safe and effective and should remain on the market, the FDA questioned 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) organization of any credible allegation related to data integrity impacting any pending application in the Novartis Group,” said Narasimhan at an investor event.

"What we realized 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. So we’re just taking judgment out of that equation."

Read the Reuters report