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# FDA Explains Novartis Data Manipulation Stance
- URL: https://www.fdaweb.com/fda-explains-novartis-data-manipulation-stance/
- Published: 2019-08-21T12:00:00.000Z
- Updated: 2026-09-15T01:45:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144821

CBER director **Peter Marks** tells *Stat News* he issued a public statement addressing Novartis’ data manipulation in the application for its Zolgensma to be sure the episode did not set back development of other gene therapies. Any case in which data are mishandled and patients are harmed could set the field of gene therapy back, Marks [said](https://www.statnews.com/2019/08/21/fda-on-novartis-data-manipulation-controversy-we-happened-to-be-lucky/?ref=fdaweb.com) in a *Stat* interview. “We just so happened to be lucky in this case when we looked at everything, at the end of the day, there’s no concern about this particular product. But we don’t want anyone to think that it isn’t important to do the right thing and to make sure that the information that we get is correct.”

Marks said that while the incident could make FDA staff sound like bureaucratic paper-pushers, there is more involved. “It’s making sure that the whole ecosystem understands that when people are working on these things that are highly technically complex, that they have to work truthfully and accurately. Because that’s the foundation upon which the trust that patients put in these products is built.”