Friday the 13th was an unlucky day for Genzyme (Cambridge, MA). On that day, the company and the US Food and Drug Administration alerted healthcare providers that stainless steel fragments, nonlatex rubber, and fiberlike material had been found in products filled at Genzyme’s Allston Landing manufacturing facility. The enzyme-replacement products Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen were affected. FDA advised that visual inspection and filtration of the products should reduce the risk of administering contaminated medicines to patients.
Considered as a single event, the discovery of particulates in a small percentage of therapies produced at the Allston Landing facility might be seen as a normal occurrence. But this episode continues a troubling trend. During the fall of 2008, FDA inspectors found “significant deviations from current good manufacturing practice” at the plant, including the “failure to establish and follow written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.”
The consequences of this failure were illustrated in June 2009, when Genzyme discovered a virus in the plant’s production equipment. Although the virus strain was not shown to cause human infection, Genzyme temporarily halted production at Allston Landing to sanitize the facility.
In this context, Friday’s announcements raise legitimate questions about whether Genzyme is taking sufficient measures to ensure the sterility of products filled at Allston Landing. I think that FDA and the company should begin investigating whether systemic problems are affecting the plant’s operations.
The new contamination also highlights the need for FDA-approved alternatives to the medicines produced at the facility. As things stand now, a prolonged halt in production at Allston Landing could seriously affect the quality of life of thousands of people. Branded or generic competition for Cerezyme and Fabrazyme, for example, would benefit patients.