What do you do when you have the the most expensive drug in the world and need to get it approved? Correct. You manipulate the data behind it.
The Food and Drug Administration said Tuesday that Novartis submitted manipulated data as part of its application for a new gene therapy, and didn’t tell the agency until after the treatment was approved.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the inaccurate information involved mouse data and was a “small amount of the totality” that was submitted. The faulty data didn’t raise concerns about the safety and effectiveness of the treatment, he said, adding that the therapy will remain on the market.
But he stressed that the agency takes data integrity issues seriously and is continuing to investigate the situation. He said the FDA “will use its full authorities to take action, if appropriate, which may include civil or criminal penalties” against the manufacturer, AveXis Inc., a subsidiary of Novartis.
Isn’t that awesome? They had the balls to play with numbers to get Zolgensma cleared, a drug which only costs $2.1 million a treatment for spinal muscular atrophy.
I will give the FDA credit for catching them. And maybe it doesn’t change the effectiveness but it is still disgusting. Makes you wonder how many times this has happened for drugs over the years.