Enforcement action likely to result in review of operations by third party
The US FDA has notified Genzyme that, while it recognises the company’s efforts, it intends to take enforcement action to ensure that products manufactured at the Allston plant are made in compliance with GMP regulations.
The enforcement action is likely to result in a consent decree, under which a third party would inspect and review the plant’s operation for an extended period and certify compliance with FDA regulations. Under a consent decree, Genzyme also would be required to make payments to the government and could incur other costs.
Genzyme expects that shipments of Cerezyme (imiglucerase for injection) and Fabrazyme (agalsidase beta), which are manufactured in Allston, will continue uninterrupted during the period of the enforcement action. It also expects that shipments of Myozyme (alglucosidase alfa) produced at the 160-L scale, which is filled and finished in Allston, will continue uninterrupted.
Genzyme also fills and finishes Thyrogen (thyrotropin alfa for injection) at the Allston plant and in the next few weeks intends to put to the agency the company’s view that there is also a patient need for uninterrupted supply of this product.
Genzyme says it will work co-operatively with the FDA to restore confidence in its ability to operate the Allston plant at the highest standards, building on the progress it has made over the past year to address the manufacturing deficiencies. This progress includes:
• Retaining a leading quality assurance advisory firm to help develop a comprehensive strategy and risk mitigation plan.
• Naming a new site head and reorganising and strengthening the management team at the facility.
• Hiring two highly regarded industry veterans to serve as president of global manufacturing and corporate operations and senior vice president of global product quality.