From the Pharmalot blog, 3 patients are foiled in their attempt to obtain a new license from the NIH via a march-in petition to allow them to produce (seek another supplier) a competitive product to Genzyme's Fabrazyme to treat Fabry's disease. This after Genzyme has suffered manufacturing woes with the product for more than 1 year.
The Department of HHS denied the request saying this proposed solution would not redress the problem in the short-run. Also, no manufacturer has ever asked for a license besides Genzyme so HHS declined to grant one to the patients under these circumstances. HHS says it will seriously consider petitions by other qualified manufacturers.
Posted by Bruce Lehr December 7th 2010.