For almost two years, patients with Fabry's disease have been dealing with severe shortages of the medicine they need — Genzyme's Fabrazyme — as Genzyme deals with manufacturing problems and contamination. A year ago, the patients asked NIH to step in and demand that Genzyme allow other drug companies to make Fabrazyme, a provision known as "march-in" rights that NIH can exercise under certain circumstances according to the Bayh-Dole Act. NIH refused, saying Genzyme had promised to have the problems fixed by early 2011. Genzyme has since reported additional problems at its manufacturing plant, and now says it won't be manufacturing Fabrazyme again before late 2011 and that it will have to allocate the remaining stocks of the drug away from American patients to overseas markets, reports Patent Docs' James DeGiulio. And so Fabry patients are asking NIH to reconsider its refusal to exercise the march-in rights. "The NIH kept the request for march-in open upon receiving information that 'progress toward restoring the supply of Fabrazyme to meet patient demand was not proceeding as represented,' and that it would revisit the petition upon receiving such information," DeGiulio says. The petitioners are asking that another manufacturer be given license to make Fabrazyme even though Genzyme still has a patent on it, he adds.
Fabry Patients Ask for Help
Apr 11, 2011