For someone who has made a point of trying to steer Novartis (NVS) away from scandal, Vas Narasimhan has committed a puzzling blunder.

Last week, the Food and Drug Administration took the highly unusual step of publicly upbraiding the company, which he has run for the past 18 months, for failing to disclose that certain data from animal testing for a gene therapy was manipulated. The drug maker apparently became aware in mid-March, but did not notify the agency until the end of June. Unaware of the problem, the FDA approved the drug in May.

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  • Indeed it is amazing—-for an issue with a product in the US there is FAR-a reporting system which means you must let the FDA know within 3 days. The FDA understands that you will investigate and nothing will happen until you complete the investigation but you must tell them. What is so different in this case…..only the fact that the drug was in the middle of the approval process. Which means it is all about the money!

  • It appears that somebody at AveXis falsified data, i.e. committed scientific fraud, which normally would get you fired. And yet, missing from this story is any report that either AveXis or Novartis has taken disciplinary action of any kind. I refrain from commenting on the irony of a government headed by the Great Prevaricator, Donald Trump–which daily commits scientific fraud–upbraiding anybody for data manipulation.

    • Hi James
      Thanks for the note.
      Two quick things. First, this is an opinion column, as opposed to a story.
      Also, I’m waiting for specifics on any disciplinary actions. But those will be reported once more is known.
      As for Trump, well, you make a good point. Let’s see how this plays out.
      Regards
      ed at pharmalot

  • Just how many times have i talked .preached and wrote the essay of The Doctrine of Normal Way Of Life that i do not go to doctor , hospital nor take any drug or medication . . in reality. which is the near to perfection that most human beings would acquire .retain with satisfaction . This only one more example as to the Power ,The Glory and Loss of Care and or Concern for any patient whom may be taking medications as such . based on what i read on either Friday or Saturday , August 08 .09. 2019 on your web site that The C.E.O Of Novartis said or stated about this whole and or dangerous Threat to humans . I made sure to write in my comments on Saturday , August 09.2019 about the similar actions .behaviours and conducts .that another Pharmaceutical Empire did the same namely Merck .with the Drug so Named Named Vioxx That killed over Five Hundred Thousands Humanbeings whom were taking Vioxx . more to come Trevor ..Merchant ,Bronx , New York City ., Tuesday . August . 13, 2019 at 5.11 p.m day light savings time .

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