AveXis, the gene therapy subsidiary of Swiss pharma giant Novartis, was aware of “data manipulation” involving its Zolgensma gene therapy for spinal muscular atrophy before it was approved in May, but did not inform the Food and Drug Administration until later, the agency said Tuesday.
Zolgensma should remain on the market, Peter Marks, the director of the agency’s Center for Biologics Evaluation and Research, said in a statement. But the FDA continues to review the data issue to see if further action is required, which may lead to “civil or criminal penalties,” according to the statement.
“We rely on truthful scientific data to make regulatory decisions, and we take the issue of data integrity very seriously,” added acting FDA Commissioner Ned Sharpless.
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In other businesses, data manipulation gets people fired, and opens the can of worms for very stiff fines / lawsuits / jail-terms / de-licensing, etc. This should thus also apply to AveXis (or its new owner Novartis). And yet even more urgently so as this business effects human lives.