Genzyme manufacturing plant consent decree

Genzyme and the FDA are getting closer to agreement on the pharmaceutical manufacturing deficiencies at the Allston plant. ...

... "Genzyme received a draft consent decree from the FDA regarding its Allston manufacturing plant. The draft provides for an up-front disgorgement of past profits of $175 million. Because this is a likely outcome, Genzyme booked this expense in the first quarter. In addition, if the Allston fill/finish facility is still operating after deadlines for domestic and exported products, the draft provides for disgorgement of 18.5 percent of revenues from sales of products manufactured and distributed from Allston after those deadlines. Genzyme and the FDA are having discussions regarding appropriate deadlines for moving fill/finish operations, as well as the details of the disgorgement provisions.

Finally, if fill/finish operations are moved from Allston but certain remediation actions relating to overall cGMP compliance are not met by deadlines over the coming years in a remediation plan to be approved by the FDA, the draft provides for a payment of $15,000 per day per violation until the compliance milestones are met. Genzyme is actively negotiating with the FDA the terms of the consent decree and expects that the negotiations will be completed during the second quarter. After finalization of the consent decree, Genzyme will provide an update, including revised 2010 financial guidance. " ...

Via Genzyme: Financial Results for the First Quarter of 2010