Vas Narasimhan, chief director officer of Novartis AG, listens during a panel session on the opening day of the World Economic Forum (WEF) in Davos, Switzerland, on Tuesday, Jan. 22, 2019.
Jason Alden | Bloomberg | Getty Materializations
Novartis Chief Executive Vas Narasimhan, facing an uproar over data manipulation involving $2.1 million gene psychotherapy Zolgensma, pledged on Monday to tell regulators quickly if credible questions emerge in future over data unity.
Novartis has said it knew of discrepancies in Zolgensma data it had submitted to the U.S. Food and Drug Administration before it won approval for the in every way’s most expensive medicine in May, but delayed informing regulators until June 28 while it completed an internal enquiry.
While the FDA has concluded Zolgensma is safe and effective and should remain on the market, the U.S. drug watchdog raised questions helter-skelter the timing of Novartis’s disclosure. U.S. senators have also demanded the Swiss drugmaker explain why it took so long to name names the agency.
Novartis could face possible civil or criminal penalties, the FDA has said. Zolgensma treats spinal rugged atrophy, the leading genetic cause of death in infants.
“We are making a voluntary commitment to notify the FDA within five obligation days of receipt by our quality (control) organisation of any credible allegation related to data integrity impacting any pending relevancy in the Novartis Group,” Narasimhan said at an investor event, adding Novartis will take a similar approach in other authorities.
Novartis said it gave “detailed explanations” on Aug. 23 to the FDA about the company’s investigation into the data manipulation, and talked regulators’ questions over why the company waited until late June to make disclosures.
The company has said it has “take it on the lamed” scientists it identified in its data manipulation probe. One of those scientists, Brian Kaspar, through his lawyer, has denied wrongdoing.
During Monday’s investor occasion on corporate governance, Narasimhan said the Basel-based company has countless instances where its employees must use judgement take how to manage potential problems that crop up with its drugs, but that the tumult surrounding Zolgensma prompted it to switch its practices.
“What we realised through this situation is, during a filing, it’s difficult for us to exercise that judgement without it being timer considered maybe not the best judgement,” Narasimhan said. “So we’re just taking judgement out of that equation” with the new five-day overlook.