Senate Finance Committee Chairman Chuck Grassley (R-Iowa) is demanding records and answers from Novartis relating to its internal inquiry over the inclusion of manipulated data in a regulatory filing that led to the approval of its gene therapy Zolgensma.
Zolgensma is a gene therapy for the rare and progressive neuromuscular disease spinal muscular atrophy. Novartis’ subsidiary AveXis failed to notify the agency until a month after winning approval, even though it was aware of the problem prior to approval.
In an August 9 letter to Novartis CEO Vasant Narasimhan, Grassley noted that according to the company’s own statement, AveXis notified the FDA on June 28, 2019 that its application included manipulated data that “impacts the accuracy of certain data from product testing performed in animals submitted in the biologics license application.” Grassley noted that AveXis waited more than a month after it won approval to notify regulators.
“Such conduct is reprehensible and could have an adverse effect on patients,” wrote Grassley. “Accordingly, the conduct ought to be investigated and, as appropriate, punished to the fullest extent of the law.”
In addition to all records relating to the withholding of Zolgensma data, Grassley wants records relating to Novartis’ internal inquiry into the matter, the timing of it, how many employees have been terminated as a result, and what steps the company is taking to ensure such occurrences do not happen in the future.
On the same day, several Democratic senators co-signed a letter to acting FDA Commissioner Norman Sharpless, saying that the “scandal smacks of the pharmaceutical industry’s privilege and greed, and Americans are sick of it.”
In the strongly worded letter, Senators Bernie Sanders (D-Vermont), Tammy Baldwin (D-Wisconsin), Elizabeth Warren (D-Massachusetts), and Richard Blumenthal (D-Connecticut) want the FDA to provide a written submission explaining why it withdrew a proposed regulation in October 2018 that would have required sponsors of certain clinical trials to promptly report suspected data falsification to FDA and whether, in light of AveXis’ actions, it plans to re-issue such regulation.
“It is unconscionable that a drug company would provide manipulated data to federal regulators in order to rush its product to market, reap federal perks, and charge the highest amount in American history for its medication. Such greed cannot be condoned by the FDA,” the senators wrote. “We urge you 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 misbehavior.”
Photo: Senator Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee
Author: Rare Daily Staff
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