5 responses

  1. CS
    December 9, 2010

    Have you contemplated the level of complexity that the setting up of a facility that would be qualified to produce Fabrazyme? What it takes to even begin the process of being able to produce a specialty drug like Fabrazyme? In the time that it would take to replicate conditions, equipment and skill level of the workers needed to produce this drug, Genzyme will have rectified the cause of the issue. It is not practical to grant a patent exception. If you do the research easily available to the public on their plan to correct their issue and catch up, you will see that Genzyme will easily be back on track before another facility could even have approvals to move ahead on a first run of the drug. The required levels of testing to get a drug approved for market make it prohibitive. One of the keys here, in my opinion, is the knowledge of the process by the manufacturing teams actually making the drug. It’s not a cookie recipe that can be sent off to another manufacturer easily.
    Before making a charge against a ‘drug giant’ or using the patients that are in need to get a crowd pop from followers by guessing at numbers, I would encourage a deeper read into the findings from the Health Institutes in the EU and US that delve into real numbers and real adverse events that patients are experiencing. And don’t think for a minute that it doesn’t weigh on the minds of those who have a hand in production, each patient means something.
    (Disclaimer – I do not work at Genzyme or have inside information but the topic is important to me.)

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  2. James Love
    December 12, 2010

    The petitioners appreciate that it is difficult to obtain an alternative supply, but they want the opportunity to try. Allen Black, the lawyer for the patients, works in the field. This is his faculty web page: http://www.law.pitt.edu/faculty/c-allen-black-jr. I would add that there is the current shortage, which has been going on for some time, and there is the possibility of this happening again. Even if the NIH believes the march-in license won’t help, they don’t have to deny the petitioners a chance to make their case in a hearing, or at least invite them to respond to their questions, for the record.

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