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Spectrum Pharmaceuticals, Inc. Message Board

  • pkarnett pkarnett Apr 30, 2012 10:14 PM Flag

    NRC peition from 2006-2007 time frame

     

    A petition was made to the NRC in 2006 to reduce the number of hours needed to administer Zevalin from 700 hours to 80 hours. Here is the petition:

    http://pbadupws.nrc.gov/docs/ML0615/ML061570302.pdf

    The petition was DENIED in 2007. See here:

    http://www.gpo.gov/fdsys/pkg/FR-2007-10-24/html/E7-20918.htm

    They denied it because they felt the 700 hours was appropriate. You can read through the entire petition and the NRC's response as to why it was denied. I haven't read through it all, just skimmed it a little.

    So yeah, Raj says "give him another year" and he is going to change it? Uh...highly unlikely given this reading.

    Man, what it fees like to suddenly be blindsided by all of this after being told the bioscan was the last hurdle (outside of dr ignorance). Zevalin is even more of a disaster than I had envisioned.

    This topic is deleted.
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    • Wow, excellent find!

      Reading the NRC decision, it appears that the 25 letters of support were generally form letters, and that the petition was very weak. On the other hand, the opposition included ACRO, ACR, and ASTRO, all influential groups of Radiologists that certainly must have been interested in keeping the administration of what was at the time, an exciting new class of drugs, entirely within their control.
      In the summary, the NRC finds that "the training and experience requirements for the parenteral administration of Zevalin (I.e. 700 hours), do not present a significant regulatory impediment to the safe and beneficial use of these radioactive materials.."
      It would likely be quite easy to prove after 6 years of experience, that on the contrary, the 700 hours of training present an enormous impediment, and essentially preclude the use Zevalin. There is also a huge body of evidence in studies that have become available over the past 6 years that would lend support to making Zevalin more readily available.
      Finally, the opposition group that fought to maintain a monopoly over the administration of Zevalin and Bexxar 6 years ago may be less interested this time around: it is clear that they have nothing to gain by maintaining their stranglehold on the regulation and administration of this class of drugs.
      I imagine that a good lawyer may be able to reopen this, present convincing new evidence in support of lifting the onerous restrictions, and avoid any serious opposition.
      Thoughts?

    • You too, enjoy yourself sherry

    • Thanks PK for your outstanding work. i feel like i'm being cheated on.

    • And how many negative threads do you "envision" starting tomorrow?

 
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