Genzyme Pays FDA $175 Million in Consent Decree Settlement

Drug maker Genzyme Corp. will pay the Food and Drug Administration $175 million to settle a consent decree, a serious enforcement action.  The FDA issued the consent decree against Genzyme after a series of manufacturing problems led to shortages of two of its drugs, Fabrazyme and Cerezyme. 

In addition to the $175 million payment, the consent decree calls for Genzyme to change the operations site for the end stages of drug production.  It will also develop a remediation plan for the plant in Allston, Mass., subject to approval by the FDA.

According to a statement issued by Genzyme, the company will continue to negotiate with the FDA to finalize the terms of the settlement.

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