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.
Genzyme said that based on its initial communication with the agency and the medical need for patients, it 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 said that it 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.
The 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.