Novartis, one of the world’s largest pharmaceutical firms, is under FDA investigation. Novartis stock is taking a tumble because the company withheld data from the FDA in its application for approval of a gene therapy treatment for spinal muscular atrophy. The FDA investigation is a setback for the company that, as of 2018, was trying to put behind it a generic price-fixing scandal, improper marketing techniques, and a previous allegation of data manipulation.
The $2.1 million gene therapy treatment was given expedited approval by the FDA. Then Novartis revealed that it was conducting an internal investigation into possible data manipulation in the testing of the drug, Zolgensma. Novartis has fired two scientists and maintains that the conduct was isolated. However, there was a two-month delay in announcing the internal investigation, a delay that permitted the drug approval process to end successfully. Novartis has defended the delay by explaining that it did not want to tip AveXis executives on the existence of the internal probe. AveXis produces the drug, and Novartis said that it feared the executives there would interfere with the investigation. Somehow a defense that is based on the fact that you do not trust the executives of your contractor seems slightly off kilter.
Novartis assures that there is no concern for safety of the patients. An FDA commissioner tweeted that he expected there would be a finding of wrongdoing and that there would be consequences. Novartis also assures that the issue was isolated to a couple of rogue scientists. If the Barometer had a nickel for every time the phrase, “These were just a couple of rogues that we have now fired,” well, this blog would not be free.
There is no such thing as isolated-rogue responsibility when it comes to events this big. Given the company’s culture as of 2018, something more than firing a couple of scientists is probably in order.