Novartis Pharmaceuticals Used Manipulated Data to Gain FDA Approval of Gene Therapy Drug
Novartis Pharmaceuticals, a global drug company, recently revealed that the company submitted an application to the United States Food and Drug Administration (FDA) for approval of Zolgensma, a gene therapy drug, with manipulated data. The FDA is aggressively investigating the situation but claims Zolgensma is still safe to be on the market. Novartis has a history of committing acts that are potentially illegal and wrongful, conduct which poses a risk of harm to patients.
What is Zolgensma?
Zolgensma is a gene therapy drug carrying a price tag of $2.1 million for one dose – the most expensive drug on the planet. Zolgensma is used to treat children under the age of 2 who have been diagnosed with spinal muscular atrophy (SMA), a rare genetic disorder involving mutations of a gene that is necessary for proper muscle control and movement. To be diagnosed with SMA, a child must inherit mutated genes from both parents.
Novartis’ Application for Approval of Zolgensma
Novartis submitted its application for FDA approval of Zolgensma in early 2019. As of March 14, 2019, AveXis, a subdivision of Novartis dedicated to gene therapy, was aware of the data manipulation. Zolgensma gained FDA approval on May 24, 2019, and according to the FDA, Novartis “did not inform FDA of the issue until over a month” after Zolgensma was approved. As such, Novartis, or at least its subdivision, AveXis, knew about the manipulated data two months before Zolgensma hit the market. AveXis was acquired by Novartis last year after the company decided to enter the gene therapy industry.
The approval of Zolgensma would likely have been delayed had the FDA been informed about the manipulated data before May 24, 2019. It is unclear whether any person beyond those working within AveXis knew about the data manipulation. However, Novartis is still responsible for the conduct of its subsidiaries.
FDA Investigation Under Way – Novartis May Face Potential Civil and Criminal Penalties
The FDA is investigating to determine how and why Novartis submitted a drug application with manipulated data. While the FDA asserts that the manipulated data pertains to animal, and not human, studies, and such data has no effect on the current use of Zolgensma, submitting a drug application with manipulated data is concerning, and a punishable act. The FDA indicates that “civil or criminal penalties” may be warranted pending results of the agency’s investigation.
Novartis Has a History of Data Manipulation and Criminal Conduct
Manipulating data on a drug application is not the only unlawful act Novartis has been linked to. Between 2013 and 2015, Novartis allegedly manipulated data and failed to report side effects for some of its drugs in Japan, prompting numerous scandals as Japanese authorities discovered the unlawful conduct.
Additionally, Novartis has faced bribery allegations in recent years in other countries, painting the drug company as corrupt. Moreover, just last year, Novartis was linked to Michael Cohen, President Trump’s former personal attorney, when it was revealed in congressional testimony that the drug company paid Michael Cohen 1.2 million to act as a consultant on matters about President Trump. Michael Cohen allegedly met with representatives from Novartis on 6 occasions, information that was never supposed to become public knowledge.
While the new CEO of Novartis has pledged to clean up the drug company’s act, the recent discovery that the company submitted a drug application to the FDA with manipulated data only furthers the company’s reputation as unlawful and corrupt.
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