Why the FDA came down hard on Novartis

The FDA departed from protocol this month when it publicly blasted Novartis over submitting doctored data. The reason, according to a high-ranking agency official, is that the stakes were too high to let the issue pass quietly.

Dr. Peter Marks, who wrote the memo castigating Novartis, said the company’s data issue threatened to undermine the entire field of gene therapy. It so happened that the manipulated data didn’t imperil the safety of Zolgensma, Novartis’s one-time treatment for spinal muscular atrophy, but that doesn’t change the imperative that companies ensure data submitted to the FDA are accurate, Marks said.

“It may sound like we’re kind of bureaucratic paper pushers, but it’s more than that,” Marks told STAT’s Matthew Herper. “It’s making sure that the whole ecosystem understands that when people are working on these things that are highly technically complex, that they have to work truthfully and accurately. Because that’s the foundation upon which the trust that patients put in these products is built.”

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