The FDA came down hard on Novartis, subjecting the company to a public flogging over the data manipulation that, at the end of the day, didn’t effect patients’ safety. But the issue is too important to give anyone a pass, officials say. “It may sound like we’re kind of bureaucratic paper-pushers, but it’s more than that,” said FDA’s Dr. Peter Marks. “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.”
Stat: FDA On Novartis Data Manipulation Controversy: ‘We Happened To Be Lucky’
Since the Food and Drug Administration blasted Novartis (NVS) earlier this month over data manipulation, one of the major questions looming over the matter has been why the agency came down so publicly on the drug maker. The answer, according to a top FDA official, is because the stakes were too high to do otherwise. Dr. Peter Marks, who wrote the memo that created a storm of controversy around Novartis and data used to support approval of the drug Zolgensma, said in an interview that any case in which data are mishandled and patients are harmed could set the whole field of gene therapy back, just as the death of a patient, Jesse Gelsinger, froze research two decades ago. (Herper, 8/21)
Stat: Scientist Denies Wrongdoing In Novartis Data Manipulation Scandal
The Novartis (NVS) scientist who was ousted by the drug maker in connection with a scandal over data manipulation broke his silence late Monday, saying through a lawyer that he categorically denied any wrongdoing and was “prepared to assert his rights and defend his conduct accordingly.” The researcher, Brian Kaspar, was dismissed from the company, along with his brother, Allan. Both were leading scientists at AveXis, which developed the gene therapy Zolgensma and which was later acquired by Novartis. The Food and Drug Administration earlier this month accused the drug maker of falsifying preclinical data related to its application for approval of the treatment. (Herper, 8/19)
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Source : Kaiser Health