Novartis inspection puts into question who knew what—and when—about Zolgensma data manipulation

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FDA Establishment Inspection Teams are doing their job on the ground - why no action from FDA Leadership?

This is by Eric Palmer, written in FiercePharma, as recently (in pharmaceutical terms) as Aug 13, 2019, reproduced verbatim below:

“Novartis, which last week was publicly shamed by the FDA for manipulating data tied to the application of its gene therapy Zolgensma, has said that it launched an investigation in March, as soon as it learned of the issue [Zolgensma is c. $2 million per treatment]

But records from the lab where the manipulation arose suggest that the company’s investigation may not have been as deep or wide as the Swiss drugmaker has proclaimed.

Documents referenced in a Form 483 by the FDA, which inspected the lab a month after it learned of the falsified records, also suggest the data-fudging began at least in early 2018 and could have been uncovered by managers at AveXis during several steps in the clinic…