Genzyme Plant Faces FDA Action

Genzyme said its Allston, Massachusetts plant will be the subject of Food & Drug Administration (FDA) enforcement action following several <"">manufacturing problems. The facility was temporarily shut down in June because of a viral contamination.

The Allston plant is the only one that makes the Gaucher’s disease treatment Cerezyme and the Fabry disease drug Fabrazyme. Last June’s shutdown resulted in a shortage of the two drugs. Globally, about 5,500 people depend on Cerezyme and about 2,500 use Fabrazyme. While production was restarted, the shortage of the two drugs is ongoing.

According to The Wall Street Journal, the Genzyme Allston plant has failed multiple regulatory inspections dating back to 2008. The FDA enforcement action is meant to insure that products manufactured at the plant are made in compliance with good manufacturing practice regulations. While the plant will be allowed to remain open, Genzyme will likely have to enter into a consent decree with the FDA.

According to the Journal, Genzyme said in a statement that the likely consent decree would have a third party inspect and review the plant’s operations for “an extended period” to ensure compliance. The move would require Genzyme to “make payments to the government and could incur other costs.”

In a press release, Genzyme said it expects that shipments of Cerezyme and Fabrazyme which are manufactured in Allston 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 at the Allston plant and intends to discuss with the FDA 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.

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