US FDA’s Rush Following Novartis’ Delay Suggests Strong Displeasure With Handling Of Zolgensma Data Manipulation
US FDA’s Rush Following Novartis’ Delay Suggests Strong Displeasure With Handling Of Zolgensma Data Manipulation
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The FDA’s early release of inspection findings of a testing lab’s possible involvement in data falsification in the testing (and subsequent FDA approval) of Zolgensma is unusual, signaling the likelihood that Novartis will face tough scrutiny of its actions – and perhaps stiff fines because of the fraud. Learn why one analyst is alluding to the possibility of a government investigation on the call Novartis held for the investment community, and why he’s calling for corporate officers to be held liable for statue violations, regardless of whether they knew of any wrongdoing.
Author: Informa Pharma Intelligence
Publisher: Pinksheet
- Description
The FDA’s early release of inspection findings regarding a testing lab’s possible involvement in data falsification leading to the subsequent FDA approval of Zolgensma is unusual, pointing to the likelihood that Novartis will face tough scrutiny of its actions – and even stiff fines because of the fraud. Novartis says it hopes to learn from the experience and will work with the FDA to improve, but one analyst alluded to the possibility of a government investigation on the call Novartis held for the investment community. Can Novartis’ corporate officers be held liable for statue violations, regardless of whether they knew of any wrongdoing or participated in any misconduct?
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