FDA primed to crack down on Novartis, as data manipulation scandal revealed


Zolgensama, Novartis’s spinal muscular atrophy gene therapy, was making all kinds of positive headlines leading up to its approval after posting stellar clinical trial results. Now these results are coming back to haunt Novartis, as it has been revealed that Novartis submitted the Zolgensama approval with manipulated data and did not inform FDA regulators until one month after FDA had approved of the treatment.

What is even more an insult to the FDA, is that Novartis was aware two months before Zolgensama was approved about the data manipulation that had taken place. If the FDA had been made away of this scandal it would have severely effected the approval process and they would have been forced into delaying their decision and opening up an investigation.

Acting FDA chief, Ned Sharpless, announced that the agency “will use its full authorities to take action, if appropriate, which may include civil or criminal penalties.” Luckily for Novartis, the FDA still wants to keep Zolgensama on the market, as the manipulation only applies ‘to a small portion of the product testing data’ in relation to the animal subjects and not the humans. With the assays ( activity tests) under scrutiny only being used for product testing and not currently used for commercial product release. Novartis has further supported this by stating ‘ the data in question were a small portion of our overall submission and are limited to older processes no longer in use.’

The issue lies in the fact that the unit where Zolgensama was produced, AveXis, was aware of its data manipulation before approval and did not make any moves to resolve the issue until one month after the FDA had approved it.

This is only the recent headline in a long line of regulatory errors by Novartis, which has been involved in a variety of scandals, such as bribery accusations and most notably from 2013-2015 in
Japan, where authorities discovered Novartis manipulated data and failed to report side effects.  

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