Novartis CEO Vas Narasimhan defended the company’s decision to delay telling the FDA about inaccurate data involving its $2.1 million gene therapy Zolgensma, saying that it “tried to do the right things” in the process, according to STAT.
Mr. Narasimhan also said that the company was forcing out a small number of scientists involved in the data manipulation at AveXis, Novartis’ gene therapy business.
Novartis learned that some of its employees had manipulated data in the Zolgensma application in March. Instead of informing the FDA immediately, Novartis conducted an internal investigation and submitted results of that probe to the FDA in late June, about one month after Zolgensma was approved by the FDA.
Mr. Narasimhan said that Novartis waited for the results of the investigation before informing the FDA because it wanted to provide the agency with the best information, not because the company wanted to secure approval before disclosing the problem.
Mr. Narasimhan said that the company “thoroughly, aggressively” investigated the issue and patient safety was never at risk, according to The New York Times.
“I think everyone in our organization can stand proud that we tried to do the right things in this instance,” Mr. Narasimhan told financial analysts on a conference call, according to STAT. “We understand the agency has a different perspective, which we respect, but we’ve tried to be transparent, thorough, science-based, and most importantly, patient-oriented to ensure that we never compromised patient safety, efficacy, or product quality during any moment during all of this.”
The FDA has threatened legal action against the drugmaker.
Date: August 12, 2019
Source: Becker’s Hospital Review