Genzyme Corporation announced on Mar. 24 that the FDA notified the company yesterday afternoon that, while the agency recognizes Genzyme’s efforts, it intends to take enforcement action to ensure that products manufactured at the plant are made in compliance with good manufacturing practice regulations. The FDA enforcement action will likely 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.
Based on its initial communication with the agency and the medical need for patients, 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. In addition, Genzyme 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 intends to discuss with the agency the company’s view that there is also a patient need for uninterrupted supply of this product. The discussions with the FDA are expected to occur over the next several weeks.
Genzyme will work cooperatively with the FDA to restore the agency’s 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 at the Allston plant. This progress includes:
Retaining a leading quality assurance advisory firm to help develop a comprehensive strategy and risk mitigation plan. More than 30 expert consultants from this firm are currently working at the Allston plant or at other Genzyme manufacturing facilities. Naming a new site head and reorganizing 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.