FDA May Take Legal Action Against Novartis Due to Inaccurate Data use for Gene Therapy

Major drug maker, Novartis may be sued by the FDA for deliberately using inaccurate data for its $2.1 million gene therapy project. The gene therapy, which was approved in May, will remain in the market while the matter is under investigation. The federal drug administration had initially approved the product on the 28 of June. However, a notice was released by AveXis.inc, a subsidiary of Novartis, stating that there was an issue with data manipulation that may have impacted the results of the testing.  

Novartis May Face Legal Action By The FDA

According to AveXis Inc, the product testing was performed on animals but the data that was submitted to the FDA for biologics licensing was inaccurate. The director of the Federal Drug Administration’s Center for Biologics Evaluation and Research, Peter Marks, said that the FDA will make sure that it utilizes every legal authority at its disposal. Novartis will face civil and criminal penalties for deliberately using inaccurate information for its spinal muscular atrophy drug.

Just after the announcement was made by the FDA, the shares of the company fell by 3.6%. At the same time, another producer of spinal muscular atrophy treatment recorded gains. It is important to note that the gene therapy treatment by Novartis, Zolgensma, is currently the most expensive drug in the world. It is a one-time treatment.

Zolgensma is used to treat muscular atrophy, a common muscle wasting illness that is responsible for the deaths of 1 in every 11,000 infants born in the United States. In response to the warning by the FDA, Novartis released a statement that muscular gene therapy is certainly safe to use. The company admitted that there is a possibility that some of the data was inaccurate but insisted that it was just a small portion.

Greg Slabodkin
About Greg Slabodkin 3587 Articles
Senior writer and editor with extensive experience covering pharma and medtech industries and international regulation. Greg has written about health information technology for several tech trade publications, with a brief stint in corporate communications for a large medical device manufacturer. Greg has also written for numerous healthcare publications read more

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