Novartis’ CEO is trying to reassure investors that the Swiss company didn’t intentionally deceive the FDA while seeking its approval for a gene therapy that costs patients $2.1 million, reports the NY Times.
Novaris delayed telling the FDA about manipulated data involving its $2.1 million gene therapy treatment—the most expensive drug in history. It stated that it “thoroughly, aggressively” investigated the issue and made the call because patient safety wasn’t threatened. Apparently, a small number of investigators were involved with the manipulation of data.
The FDA issued an appropriate public rebuke for this behavior. Novartis’ position that the falsified data posed no risk misses the point. It demonstrates the values and ethics of the CEO. Quality is as much about integrity and transparency as it is safety.
TrialSite News will drill down into the scientists involved and a deeper review of the decision logic.
In the meantime, Novartis goes under our PharmaWatch Challenged category.