FDA accuses Novartis of Hiding Problematic Data before Drug Approval

Food and Drug Administration (FDA) said in a statement on Tuesday that pharmaceutical giant, Novartis hid manipulated data fo a gene therapy drug before getting its drug approval. Novartis withheld a problem with some testing data until after the gene therapy, which costs around 2.1 million USD was approved.

In an official statement, the FDA of the US said that the swiss drugmaker hid problematic data regarding animal testing and not patient testing. But, Novartis is confident that the revolutionary drug, known as Zolgensma, would remain open on the market regardless of the allegations. The FDA stated that it started the investigation and it will consider criminal penalties if any. This problem came into the light when AveXis Inc, a Novartis subsidiary which manufactures Zolgensma reported to the agency five weeks after its drug approval. AveXis Inc told the agency about the data manipulation problem about animal testing to the agency as soon as it found about the error. FDA said that Novartis knew about the error before the approval and yet did not mention it. The data that was withheld was a small subset of animal testing, which resulted in inaccurate results. Ned Sharpless, who is the acting commissioner of FDA, said that the agency would do everything in its power to take appropriate actions.

Novartis, in an official statement, said that as soon as its subsidiary learned of the alleged manipulation in one of the animal testing procedures, the company began investigating. According to the company, they shared it with the FDA when they had an interim conclusion about the problem. It did not disclose why the data was withheld before the approval of Zolgenmsa by the FDA. They said that the manipulated subset is not used in manufacturing the therapy, and Zolgensma is effective and safe to use. Zolgensma is the most expensive one time use drug to be manufactured for infants for spinal muscular atrophy. Around 400 babies suffer from it in the US annually causing infant deaths.