FDA decides not to penalize Novartis for Zolgensma data manipulation

The FDA decided not to impose any penalties on Novartis for a data manipulation scandal involving the world's most expensive drug, Zolgensma, Stat reported. 

Zolgensma, a gene therapy drug that costs $2.1 million per dose, was approved by the FDA last May. At the time of its approval, Novartis knew it had submitted inaccurate data in the drug application but didn't tell the FDA about it until after it received approval. 

The data error hindered the accuracy of some of the data from animal trials, but didn't affect human clinical trials, according to Stat

In September, Novartis pledged to more quickly notify the FDA about data manipulation concerns that could affect drug applications. 

The FDA had threatened civil or criminal action against Novartis, but ended up classifying the review of the incident as "voluntary action indicated," meaning the agency found significant and objectionable conditions, but decided they didn't warrant further regulator action, according to Stat. The decision was disclosed at a March 30 investor presentation. 

Read the full article here.

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