Has Novartis changed its practices?

Novartis points to a number of reforms. It accepted a new corporate integrity agreement with the HHS Inspector General as part of the 2020 speaker-programme settlement, including reductions in how much it may spend on speaker programmes, and committed to shift medical education to digital formats. After the Zolgensma episode, the CEO pledged greater transparency on data integrity and described the problem as isolated. The FCPA resolution required three years of self-reporting on compliance.

Sceptics note that a 2019 FDA inspection report showed AveXis personnel had been aware of potential data manipulation dating back to January 2018, and that the state fraudulent-transfer allegations over Sandoz arose after these pledges. Whether reforms have taken hold is ultimately a judgement readers must make from the evidence.