FDA Fines Genzyme For Issues With Manufacturing

WASHINGTON (AP) — Biotech drugmaker Genzyme Corp. has agreed to pay a $175 million penalty to federal regulators in connection with long-standing manufacturing problems that have already cost the company millions. The Food and Drug Administration said Monday the company signed a legal agreement to fix problems at an Allston, Mass.

WASHINGTON (AP) — Biotech drugmaker Genzyme Corp. has agreed to pay a $175 million penalty to federal regulators in connection with long-standing manufacturing problems that have already cost the company millions.

The Food and Drug Administration said Monday the company signed a legal agreement to fix problems at an Allston, Mass., facility that makes injectable biotech drugs.

Under terms of the consent decree, Genzyme must map out a plan for overhauling the plant and stick to a preset timetable or face additional fines. The decree also sets a deadline for transferring Genzyme's operation for filling drug vials to a new manufacturing site.

"It is critical for the safety of the drug supply that companies comply with basic manufacturing standards," said FDA principal deputy commissioner Joshua Sharfstein. "FDA takes these obligations very seriously and expects manufacturers to do the same."

In June, the Cambridge, Mass.-based company shut down the plant for about three months to clean up viral contamination that had been slowing production of the drugs Cerezyme and Fabrazyme. The virus was not harmful to people, but the shutdown was costly. During the fourth quarter, profit plunged 73 percent to $23.2 million on lower sales.

In November, the FDA says it found tiny particles of trash in drugs made by Genzyme, including steel, rubber and fiber. The agency recommended that doctors closely inspect vials of four drugs made at the plant: Cerezyme, Fabrazyme, Myozyme and Thyrogen.

Since January, Genzyme has restructured its manufacturing operations, naming a new president of global manufacturing and corporate operations, along with a senior vice president of global product quality. It also contracted manufacturing for some of its key products to Hospira Inc.

Prior to the problems with its Allston plant Genzyme was considered a leading light within the biotech industry, building a multibillion dollar business around treatments for rare diseases.

Cerezyme treats Gaucher disease, an enzyme disorder that can result in liver and neurological problems, while Fabrazyme treats an inherited disorder known as Fabry disease, which is caused by the buildup of a particular type of fat in the body's cells. Myozyme treats Pompe disease, which interferes with muscle development and Thyrogen is used to diagnose thyroid cancer.

Shares of Genzyme fell 52 cents, or 1 percent, to $48.90 in afternoon trading.

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