An embarrassing scandal that Novartis (NVS) endured over data integrity has quietly come to a close, with the Food and Drug Administration instructing the drug maker to correct the problem at its AveXis unit, but without imposing any penalties.
At issue was a delay in the disclosing to the agency that manipulated data existed for its Zolgensma gene therapy. Novartis became aware of the problem in March 2019, but did not inform the FDA until after the drug was approved last May. Zolgensma, which costs $2.1 million, is used to treat a type of spinal muscular atrophy and was developed by AveXis, which Novartis bought in April 2018.
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Cut through the fat, and this is a case of greedy malfeasance that will go unpunished by the federal agency charged with preventing it (and penalizing it when necessary). When FDA decided to refer to Big Pharma as “customers” rather than “regulated entities,” the role-flipping was clear. And when PDUFA appeared, the transfer of ownership to Big Pharma was complete. Now we have these FDA surrenders and approvals for drugs that FDA knows do not work.