FDA on Novartis data manipulation controversy: 'We happened to be lucky'
A top agency official suggested that the FDA was so distressed by the matter in part because the stakes in gene therapy research are so high.
News: FDA official weighs in with
on Novartis data manipulation controversy: ‘We happened to be lucky’
Great piece by
about the bewildering incident of data problems at Novartis. Dr. Peter Marks is right: FDA's entire approval process depends on trust. If that goes, we're cooked. So lies of any kind must be dealt with firmly
An important lesson from the Novartis data manipulation scandal, a top FDA official said: Providing accurate data is paramount, even if "it may take a little more time to get there.”
I spoke to FDA's Peter Marks about $NVS Zolgensma. "We just so happened to be lucky in this case..." he said. But submitting flawed data endangers "the foundation upon which the trust that patients put in these products is built.”
FDA on Novartis data manipulation controversy: ‘We happened to be lucky’