Novartis continues to blame AveXis executives in Zolgensama data scandal


Novartis has given the FDA a plan of actions it will implement to prevent an event like the Zolgensama data scandal from happening again, but the big pharma company continues to be adamant that the blame lies squarely on the two AveXis executives.

Novartis states that AveXis co-founders, Brian and Allen Kaspar, either directly manipulated the data themselves or pressured employees to do so. As well as alleging that they held up the internal investigation that Novartis submitted when it found out about the case.

Novartis has decided to shift AveXis’s quality control function in-house with a new senior executive appointed to oversee the process and future compliance. Also part of the remediation plans is a whistleblower scheme across AveXis, to encourage reporting of misconduct and fraud as well as a programme to retrain AveXis’s quality unit employees and Novartis stated that they will let the FDA know within five days if it receives credible allegations.

This move by Novartis effectively shifts the light that garnered attention from the FDA and the public simultaneously. Primarily that Novartis was aware of the manipulation of the animal testing data included in its submission before Zolgensama was approved but only told the agency after receiving marketing authorization in the US. It was this element of the scandal that brought Novartis the attention of US lawmakers.

No comments:

Post a Comment

Coranavirus and its relationship with IP exclusivity

With the global shutdown that has occurred due to COVID-19, its presence has caused long-lasting effects in all aspects of our lives and t...