WASHINGTON — A group of senators, including presidential hopefuls Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.), blasted Novartis on Friday for failing to promptly disclose that falsified data were used to win approval for the company’s $2.1 million gene therapy, Zolgensma.
The Food and Drug Administration earlier this week said AveXis, a subsidiary of Novartis, was aware of “data manipulation” involving Zolgensma, which was approved in May to treat spinal muscular atrophy, but failed to disclose it to the agency until months later.
“Such greed cannot be condoned by the FDA,” the group of senators, led by Sen. Dick Durbin (D-Ill.), wrote in a letter to the agency’s acting commissioner, Ned Sharpless. “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.”
About the Author Reprints
I read the investigator’s FDA 483 report. This does not seem like a concerted effort to fabricate favorable data. I see plenty of that in FDA Warning Letters where certain manufacturers have discarded unfavorable data, changed computer clocks and recollected data until passing results are obtained. No, in this case it seems more like sloppy data recording practices and unacceptable procedures to fix documentation errors. The evidence presented does not seem to indicate that, “…falsified data were used to win approval…” If there is more evidence behind the scenes to drive this level of outrage, it has not yet been presented.
Nail the unscrupulous utterly selfish profiteers at hyper-expensive drug makers AveXis / Novartis – as would occur in any other business !! This is NOT a game in political arenas – but the right-inclined can sure capitalize on this drug ploy.
This happens a lot for psychiatric drugs – check out the following newly published study:
Munkholm, K., Paludan-Miller, A. S., & Boesen K. (2019). Considering the methodological limitations in the evidence base of antidepressants for depression: A reanalysis of a network meta-analysis. BMJ Open, 9(e024886).
I like to debate Bernie and Elizabeth on how the US drug supply chain works and why it not all manufactures They are clueless.
Re your statements and or report here today , Friday , August , 09. 2019 reflecting The .F.D. A that they The F.D.A . is considering charging Novartis .one of the Pharmaceutical Empires of drugs deaths , Some how i am not surprised , Thanks . Trevor Merchant . 4. 21 p.m daylight savings time . N.Y.C
Gee, it must be election season. Why else are the politicos meddling in FDA business? Could it be a play to the public??
Gee at least they are calling them on it! where’s the Republican Senators why aren’t they concerned that these Medications are over Priced, most People couldn’t begin to afford them to begin with , they are pushing the price of Drugs that are too high already, Drugs that Taxpayers are already paying these greedy Drug Companies over the top Prices! every one should be concerned that our Government allows them to gouge Taxpayers that Paid for their research, so why wouldn’t they be concerned, why wouldn’t you be?
“What makes this unscrupulous action even more appalling is the fact that AveXis was the beneficiary of numerous federal taxpayer-funded benefits and incentives, including obtaining Fast Track, Breakthrough Therapy, and Priority Review designations — ensuring that Zolgensma would be sped through the regulatory approval process,” the senators wrote. “All the while, AveXis breaks records, and budgets, with its staggering $2.1 million price.”