FDA on Novartis data manipulation controversy: ‘we happened to be lucky’

Stat News

21 August 2019 - Since the FDA blasted Novartis 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.

Read Stat News article

Michael Wonder

Posted by:

Michael Wonder

Posted in:

US , Regulation , Gene therapy , Data