AveXis, a subsidiary of Novartis AG (NYSE: NVS), has been accused of submitting manipulated data to the U.S. Food and Drug Administration (FDA) ahead of the approval of its gene-therapy drug Zolgensma. The FDA revealed the data-manipulation issue earlier this week. The agency is now considering imposing either civil or criminal penalties on the company.
Zolgensma, which was approved in May to treat spinal muscular atrophy, is currently the most expensive drug in the world at $2.1 million for a course of treatment. Novartis reportedly first learned about the data problem in March, but didn’t disclose it to the FDA until a month after the approval, on June 28. Novartis CEO Vas Narasimhan said the company had been investigating the allegations itself and denied any of the company’s actions on the matter were influenced by the timing of Zolgensma’s approval.
The FDA has said that the manipulated data affected only a small portion of product-testing data. Novartis claims that the data manipulation was carried out by only a few people, and that they would be “exited” from the company. The agency has expressed confidence that Zolgensma is still safe to be sold.
Five senators wrote a letter to Ned Sharpless, the acting head of the FDA encouraging him to “use your full authorities to hold AveXis accountable for its malfeasance.” The senators wrote: “This scandal smacks of the pharmaceutical industry’s privilege and greed, and Americans are sick of it.” The letter continued on to say that “anything short of a forceful response would signal a green light to future pharmaceutical misbehavior.” In addition to Elizabeth Warren and Bernie Sanders, both 2020 presidential hopefuls, the letter was also signed by Sens. Richard Durbin, Tammy Baldwin and Richard Blumenthal, who are all Democrats.