6 August 2019 - The failure to report the issue has not put patients at risk, the F.D.A. said, but the drugmaker could face criminal and civil penalties.

The drug maker Novartis concealed manipulated data from the Food and Drug Administration while applying for approval of an extremely expensive gene therapy treatment and then delayed reporting the issue, the agency said on Tuesday.

Officials said the inaccurate data, which involved testing in mice of two different strengths of the treatment, did not affect the safety or efficacy of the therapy, Zolgensma, used to treat a rare, often fatal genetic disease called spinal muscular atrophy.

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