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Since the Food and Drug Administration 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 statement 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.

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  • Z is not approved in Europe, and now will take longer to do so, because of this appalling lack of seriousness? frankness? candor? honesty? from Novartis. If the drug works, Europeans will not have access until much longer than anticipated. If it doesn’t work, good job FDA, for spotting inconsistencies! With 800 (?) other gene therapies in line, let’s get our pharmaceutical act – I wanted to say something else – together! This is unacceptable from an end-user (patient) point of view.

  • Most surely i have written and or stated sufficient responses to this one more of the Health Care .System or Industry . with This Nation , The United States Of America , that which most of not all are predicated with the intent for blood money profits Primarily . rather than the health and safety of humans by The Pharmaceutical Empires , The Chain Hospitals . The Bribed Drug Dealers Doctors In White Coats and The Pharmacies . The Novartis Current Issue is only one more example . I thank you Trevor Merchant . Bronx . New York City . Thursday . August . 22, 2019 at 3. 12 p.m . daylight savings time . N.Y.C

  • “why the agency came down so publicly on the drug maker. ” — Really? Instead of applauding some semblance of integrity (minor mind you, after all, Novartis simply gamed the FDA) we question why the FDA wagged the finger at the culprit? The entirety of the drug approval system is a farce where companies play the tune and the FDA dances.

  • Once again, it shows how out of control the regulations of fda have become. Marks admits that something which has no relevance to or impact on risk/benefit of a medication (“we got lucky” that this error does not really matter), WOULD have caused a delay to the approval of this medicine, had they known about it sooner. It is noteworthy that he doesn’t mention how much of a delay. A CRL could have delayed it by a year+. And how many would have lost the ability to walk and gone onto ventilators over the length of that delay?
    It only shows the review process (which takes the FDA 8 months or 12 months to do, and 2 of those months are just to confirm that all the required sections are within the application) has morphed into a bureaucratic mess.

    “We can’t make sure they do the experiments right” – such arrogance. Of course they can’t – they are too busy taking their sweet time over 12 months to review all that paperwork for each new drug application.
    The FDA employees responsible for reviewing the irrelevant portions of the applications (like whatever one is being referenced in this article and incident) have too much power to derail life saving medications.
    Until it is made clear what exactly happened with this particular bit of data, all we know is that something was “manipulated” and all we can say is that Novartis has to take responsibility (and they did, considering they fired those who did it). Beyond that we have no idea what actually happened and it could have been an honest mistake until proven otherwise.

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