Genzyme Meets Consent Decree Deadline - Pharmaceutical Technology

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Genzyme Meets Consent Decree Deadline


ePT--the Electronic Newsletter of Pharmaceutical Technology

On Nov. 24, 2010, Genzyme (Cambridge, MA) officially ended fill–finish operations at its Allston Landing, Massachusetts, plant for products sold in the United States, thereby fulfilling a requirement of a US Food and Drug Administration consent decree. Genzyme has transferred all fill–finish activities for its Cerezyme (imiglucerase for injection), Myozyme (alglucosidase alfa), Fabrazyme (agalsidase beta), and Thyrogen (thyrotropin alfa for injection) products for the US market to its Waterford, Ireland, plant and to a third-party contract manufacturer. This change effectively lifts all previous restrictions on the company’s marketing and distribution of Thyrogen within the United States.

The consent decree requires Genzyme to end all remaining fill–finish activities in Allston Landing for products sold outside of the United States by August 31, 2011. Genzyme is cooperating with regulatory authorities to achieve this goal.

During an inspection of the Allston Landing plant from Oct. 8, 2009 to Nov. 13, 2009, FDA inspectors concluded that Genzyme’s systems for ensuring manufacturing quality were inadequate, thus causing production delays, critical shortages of medically necessary products, and contamination. The plant’s manufacturing problems violated FDA’s regulations for good manufacturing practice, according to the agency. The consent decree, which Genzyme signed in May 2010, requires the company to correct manufacturing-quality violations at the plant.

FDA required Genzyme to draft a remediation plan that includes ongoing oversight from Quantic, the company’s third-party consultant. If remediation actions are not complete by certain milestones, Genzyme must pay FDA $15,000 per day per affected drug until the compliance milestones are met. After the remediation plan has been completed, Quantic will oversee Genzyme for five years and submit annual reports to the agency. Genzyme expects that the remediation plan will require approximately two to three years to complete.

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