Novartis CEO Says FDA Process Could Have Been Handled Better
Novartis CEO Says FDA Process Could Have Been Handled Better
(Bloomberg) -- Novartis AG Chief Executive Officer Vas Narasimhan said the company could have handled a furor surrounding its Zolgensma gene therapy better.
Narasimhan, who became CEO of the pharmaceutical manufacturer last year, made the comment in a company call with 12,000 managers, according to newspaper Schweiz am Wochenende. Looking back, Narasimhan said he recognized opportunities where Novartis could have handled the situation better. Narasimhan said he is not perfect as a CEO and “we will all keep working on it.”
The Swiss company is under fire from U.S. lawmakers who say it should have told regulators about data irregularities before the drug’s approval in May, rather than waiting to conclude an internal investigation.
Novartis has said that it learned of the data manipulation on March 14 and alerted the U.S. Food and Drug Administration about a month after the drug gained U.S. approval. That timeline has created an outcry among doctors and ethicists and in Washington, where a recent focus on soaring drug costs has put the actions of pharmaceutical companies and regulators under intense scrutiny.
The company told the FDA in June that it had discovered the potential manipulation of animal-testing data related to the medication, weeks after the $2.1 million-a-dose treatment had hit the U.S. market.
A spokesman for Novartis could not immediately be reached for comment.
To contact the reporter on this story: Patrick Winters in Zurich at pwinters3@bloomberg.net
To contact the editors responsible for this story: Dale Crofts at dcrofts@bloomberg.net, Helen Robertson, Tony Czuczka
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