Genzyme announced today that it expects several weeks of negotiations with the FDA following a consent decree that it anticipates regarding its troubled Allston Landing facility, outside Boston. A spokesperson added that, in a phone conversation with the FDA yesterday, the regulator said further action is forthcoming.
According to a Genzyme announcement, the FDA yesterday acknowledged the drugmaker's efforts to bring the facility back up to snuff. But it is nonetheless likely to impose the consent decree to ensure drugs coming from the facility are made in compliance with Good Manufacturing Practice standards. The decree will require the drugmaker to hire consultants for third-party inspection and review of the fixes.
Genzyme is unaware of any current trigger for the enforcement action, but sees it as part of the unfolding regulatory process at the troubled plant.
"This was always a possibility," CEO Henri Termer says during the call. "We are very well prepared; our new leadership has the relevant experience."
Still, the ongoing incident has irked investors, including Carl Icahn, who has lobbied for Termeer's ouster.
Leadership changes that have followed the plant's troubles include the addition of Robert Bertolini to the Genzyme board. As CFO at Schering-Plough in 2002, he helped the drug company navigate out from under a consent decree for manufacturing shortcomings. The company also made several additional executive-level hires in the manufacturing, quality, and regulatory areas.
Genzyme has struggled with facility fixes that stretch back to GMP violations cited following a fall 2008 FDA inspection. Matters got worse when the company discovered a bioreactor contaminated with Vesivirus 2117, leading to the plant's shutdown last summer for decontamination, a process that lingered into the fall.
Allston Landing is the manufacturing site for Genzyme product leaders Cerezyme, Fabrazyme and Myozyme. The company says it expects production to continue during the operations makeover, given supply limitations that followed the facility shutdown last summer.
- here's Genzyme's release