WASHINGTON — 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
The Food and Drug Administration
said 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
“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.
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.