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Elizabeth Warren and Bernie Sanders just slammed the Swiss drug giant Novartis over a new controversy swirling around the world’s most expensive drug

Lottie Casas August 9, 2019
  • Elizabeth Warren and Bernie Sanders are among a group of five senators who slammed Novartis’s AveXis for submitting manipulated data to the FDA ahead of the approval of its gene-therapy drug.
  • The FDArevealed the data manipulation issue earlier this week, saying that it affected only a small portion of product testing data and that the regulator was confident the drug, Zolgensma, should keep being sold.
  • “This scandal smacks of the pharmaceutical industry’s privilege and greed, and Americans are sick of it,” the senators wrote in aletter to the acting head of the FDA, Ned Sharpless.
  • Novartis said it first learned about the data problem in March. But the Swiss drug giant only informed the FDA months later, after the gene therapy, called Zolgensma, was approved,the FDA said.
  • The five senators encouraged the FDA to “use your full authorities to hold AveXis accountable for its malfeasance,” adding that “anything short of a forceful response would signal a green light to future pharmaceutical misbehavior.”
  • Visit Business Insider’s homepage for more stories.

Five senators, including Elizabeth Warren and Bernie Sanders, are slamming the Swiss drug giantNovartis for submitting manipulated data to the US FDA — which was part of a package that led to its $2.1 million drug getting approved.

The Food and Drug Administration made the data problem publicearlier this week. It appears to only affect a small amount of data and the FDA said it “remains confident” the drug, Zolgensma, should still be sold.

In the pharmaceutical industry, where data is the basis for approvals of life-or-death drugs, data manipulation is serious business. The controversy has bubbled up this week, magnified by the visibility of Zolgensma, which at $2.1 million isthe most expensive drug in the world, as well as thehigh profile of Novartis, whose new, young, and charismatic CEO has sought totransform the company.

“This scandal smacks of the pharmaceutical industry’s privilege and greed, and Americans are sick of it,” the senators wrote in the letter, which was addressed to the FDA’s acting head, Ned Sharpless. In addition to Warren and Sanders, both 2020 presidential hopefuls, the letter was also signed by Sens. Richard Durbin, Tammy Baldwin and Richard Blumenthal, who are all Democrats.

Novartis declined to comment on the letter from the Senators.

Data manipulation timeline provokes outrage from senators

The timeline of Novartis’s disclosure to the FDA also inspired ire from the senators. Novartis heard allegations of data manipulation in March of this year, before Zolgensmawas approved in late May. But the drugmaker only disclosed it to the FDA a month after the approval, on June 28, the FDAsaid.

Read more: A top executive at Swiss drug giant Novartis told us the inside story of the $2.1 million price tag for the most expensive drug in the world

In a conference call with investors this week, Novartis CEO Vas Narasimhan said that the company had been investigating the allegations itself and denied that it had been influenced by the timing of Zolgensma’s approval. The data manipulation was carried out by only a few people and Novartis would “exit” them, he said.

The drugmaker “tried to do all of the right things,” Narasimhan said. “There will be bumps on the road, we’ll never be perfect, but we will be relentless in trying to keep improving and being the most highly respected company in our industry.”

But the senators disagreed, calling Novartis’s actions “unconscionable” and urging the FDA to take action. The regulator has previously said that it could impose either civil or criminal penalties.

“We urge you to use your full authorities to hold AveXis accountable for its malfeasance,” they said. “Anything short of a forceful response would signal a green light to future pharmaceutical misbehavior.”

The senators also asked the FDA why it had scrapped a regulation proposed last fall, which would have required healthcare companies toquickly report falsified data, and asked whether that regulation would be re-issued because of the AveXis news.

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