According to this story in Boston.com, Genzyme has met all the milestones so far that the FDA has set for them in relation to its consent decree over failings at the Allston manufacturing facility. Under the final terms of the consent decree announced in May, Genzyme agreed to stop the "filling and finishing" step at Allston for all of its drugs that are distributed in the United States. The deadline for meeting this provision is the end of November 2010.
Genzyme transferred the fill & finish steps for Thyrogen (thyroid cancer) and Fabrazyme (Fabry's disease) from Allston to its plant in Ireland or outsourced to third parties. Allston still makes Cerezyme and Fabrazyme but not doing fill & finish work on them. Allston can do fill & finish work on drugs NOT distributed in the US. Ed. Note - I guess we can export bad work but don't want to see it here - the deadline for ceasing distribution to rest of planet is August 31st according to this article.
Posted by Bruce Lehr November 24th 2010.
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