Novartis made headlines earlier this year with the debut of Zolgensma, the most-expensive drug to receive FDA approval to date.

Now, the drugmaker and its $2.1 million treatment are back in the headlines–this time facing potential criminal charges after the FDA said that Novartis withheld information about an error in testing data until after the drug was approved.

The drug was approved on May 24, and it was about another month before the company notified the FDA of the problem with the data.

Zolgensma is a gene therapy used to treat the childhood disease spinal muscular atrophy. According to a statement, the FDA “remains confident that Zolgensma should remain on the market,” even though Peter Marks, an FDA official, adds that “[t]he agency will use its full authorities to take action, if appropriate, which may include civil or criminal penalties.”

As reported by the Associated Press, AveXis Inc., the Novartis subsidiary that manufactures Zolgensma, brought a “data manipulation issue” related to testing performed on animals to the FDA’s attention five weeks after the drug’s approval. Although Novartis says the animal test is not to be used in making the therapy for patients, the company did not address the issue of why the inaccuracy was not immediately reported to the FDA.

The FDA staff also found several deficiencies, including a failure to completely follow quality control procedures, in a recent inspection of the company’s Irvine, California, manufacturing plant.

“The totality of the evidence demonstrating the product’s effectiveness and its safety profile continues to provide compelling evidence supporting an overall favorable benefit-risk profile,” Marks says. ”However, the integrity of the product testing data used in the development of the product’s manufacturing process is still a matter that we are continuing to evaluate and take very seriously.”

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Novartis's $2.1 million life-saving drug facing FDA scrutiny

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