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Senators call on FDA to use "forceful response" against Novartis over faulty data scandal

Published on 12/08/19 at 10:46am

Five senators, including presidential candidates Bernie Sanders and Elizabeth Warren, have condemned Novartis for using “falsified data… to obtain approval of its gene therapy, Zolgensma… the most expensive medication in American history.”

In a letter to acting FDA commissioner Ned Sharpless, the senators said that the scandal surrounding Novartis subsidiary AveXis’ use of faulty data in the approval process for the $2.1 million gene therapy Zolgensma “smacks of the pharmaceutical industry’s privilege and greed, and American’s are sick of it.”

The Senators condemned Novartis for "knowingly misleading the FDA in a rush to make a profit" as they described the firm's "greed-driven behaviour" as an "outrage."

The senators thus called on the FDA to “use your full authorities to hold AveXis accountable for its malfeasance, including through all appropriate criminal, civil and regulatory actions against the company.”

“Anything short of a forceful response would signal a green light to future pharmaceutical behaviour,” the senators said.

Louis Goss

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