FDA Weighs Action On Genzyme Plant

Following repeated problems at Genzyme’s Allston, Mass., site, FDA appears ready to take legal action to force the biotech firm to comply with current Good Manufacturing Practices. Genzyme said FDA is likely to propose a consent decree, which calls for a third party to inspect operations over time and is usually accompanied by a hefty fine. Manufacturing deficiencies at Allston have already cost Genzyme hundreds of millions of dollars in sales of the Gaucher disease treatment Cerezyme and the Fabry disease drug Fabrazyme. Meanwhile, patients with the rare diseases have had to restrict doses of the drugs because of the manufacturing woes.