FDA To Take Enforcement Action Against Genzyme for GMP Violations

ePT--the Electronic Newsletter of Pharmaceutical Technology

Biotechnology company Genzyme reported that FDA notified the company that it intends to take enforcement action to ensure that products are made in compliance with good manufacturing practice (GMP) regulations.

The biotechnology company Genzyme (Cambridge, MA) reported last week that the US Food and Drug Administration notified the company that the agency intends to take enforcement action to ensure that products manufactured at the company’s plant in Allston Landing, Massachusetts, are made in compliance with good manufacturing practice (GMP) regulations. Genzyme said that 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.

FDA issued a warning letter to Genzyme in February 2009 following inspection of the facility in Allston Landing for GMP violations in the manufacture of drug products, bulk drug substances, and drug components for Fabrazyme (agalsidase beta), Cerezyme (imiglucerase for injection), and Myozyme (alglucosidase alfa). Since then, the company has been working to resolve these issues.

In a press statement on Mar. 24, 2010, Genzyme said that based on its initial communication with FDA and the medical need for patients, it expects that shipments of Cerezyme, and Fabrazyme, which are manufactured in the Allston facility, will continue uninterrupted during the period of the enforcement action. In addition, Genzyme expects that shipments of Myozyme 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 during the next several weeks.

Genzyme says it will work cooperatively with 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,” said the company in its statement. According to the company, this progress includes retaining a quality-assurance advisory firm to help develop a comprehensive strategy and risk-mitigation plan. More than 30 consultants from this firm are working at the Allston plant or at other Genzyme manufacturing facilities. Genzyme also named a new site head and is reorganizing its management team at the facility, which includes hiring a new president of global manufacturing and corporate operations and a new senior vice-president of global product quality.