Memo to the Novartis CEO: when in doubt, give the FDA a heads-up

Stat News

13 August 2019 - For someone who has made a point of trying to steer Novartis away from scandal, Vas Narasimhan has committed a puzzling blunder.

Last week, the FDA took the highly unusual step of publicly upbraiding the company, which he has run for the past 18 months, for failing to disclose that certain data from animal testing for a gene therapy was manipulated. The drug maker apparently became aware in mid-March, but did not notify the agency until the end of June. Unaware of the problem, the FDA approved the drug in May.

Despite their anger, agency officials believe the drug would have been approved anyway. Just the same, the company may face civil and criminal penalties after an investigation plays out.

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Michael Wonder

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Michael Wonder

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US , Regulation , Gene therapy