For months now, Genzyme has been cleaning up its act. It's been working on problems at its Boston-area plant, first ridding the place of viral contamination and then ramping up production under the FDA's watchful eye. Executives were crossing their fingers, hoping that the agency would finally give it the all-clear.
That's not going to happen, at least not right now. In fact, the government is effectively going to move in on Genzyme. The agency says it plans to put the company's manufacturing operations under FDA control via a consent decree. A "third party" would inspect and oversee the troubled plant's operations to make sure it's up to standard. The decree also would require Genzyme to make payments to the government and perhaps foot the bill for other costs.
It's not as if the company hasn't been trying: It brought a new manager in to overhaul the Boston plant, appointed an ex-Schering-Plough executive to its board for extra guidance, and scrambled to conform to FDA standards. But there were clues that those efforts might not be enough: The company had to warn patients and doctors when it found shards of steel and rubber in some vials of its drugs. And just last week, the company announced that it had found chemical contamination in one vial of Cerezyme produced at its Irish plant.
"While the agency recognizes Genzyme's efforts," the company says in a statement, "it intends to take enforcement action to ensure that products manufactured at the plant are made in compliance with good manufacturing practice regulations." While the decree is in force, Genzyme expects to ship its rare-disease drugs as usual.