Genzyme says it has met FDA milestones
Genzyme Corp. said today it has met milestones under its consent decree with the Food and Drug Administration by moving a production step for some of its drugs out of its troubled Allston plant.
During the summer of 2009, Cambridge-based Genzyme shut the Allston facility for several weeks to sanitize the facility's equipment, where a virus had been detected. Full operations later resumed.
But under a the final terms of consent decree with the FDA, announced in May, Genzyme agreed to stop the "filling and finishing" step of the production process at Allston for all of its drugs that are distributed in the United States, the company said in a press release.
The deadline for meeting that goal is the end of November. (Filling and finishing is essentially bottling a drug in vials for distribution. It is deemed a separate step from manufacturing a drug.)
Today Genzyme said it has met some of the goals spelled out in the FDA decree by ending filling and finishing work at Allston for all drugs that are distributed within the United States. The deadline for meeting this goal is Nov. 30.
In today's release, Genzyme said it has transferred the filling and finishing process for Thyrogen, a drug used to help in the diagnosis of thyroid cancer, and Fabrazyme, a drug for Fabry disease, from Allston to a Genzyme plant in Ireland and to other locations operated by third-party contractors. Earlier, Genzyme had taken some similar steps for other drugs that had been filled and finished in Allston.
The Allston facility is currently making Cerezyme and Fabrazyme, drugs that treat enzyme deficiencies. The facility is also doing filling and finishing work for other drugs that are distributed outside the United States.
Under the FDA consent decree, the Allston facility must end all filling and finishing work, including work for drugs distributed outside the US, by Aug. 31.