Start Date: 2010
Financial penalties: $175 million, plus fines for missed deadlines
End Date: still pending
This high-visibility consent decree started with manufacturing quality problems at the biopharma's Allston Landing plant, just outside Boston. GMP violations discovered during a fall 2008 inspection led to a warning letter in February 2009. But the big trouble started when a virus contaminated a bioreactor, leading to a plant shutdown for decontamination. The shutdown seemed to roll into a consent decree remediation effort, which ultimately involved an operations restructuring.
Genzyme can trace its current takeover bullying by Sanofi to the consent decree issued this past May. The French drugmaker's offer is pinned to the company's post-consent-decree valuation, rather than the higher pre-decree valuation that Genzyme prefers. The biopharma also can trace to the decree its past bullying by investor Carl Icahn, who cited the manufacturing problems in his successful attempts to make changes to the company's board.
The FDA deemed $175 million of the company's earnings as unlawful profits from the products made at the plant, chiefly Cerezyme and Fabrazyme. Genzyme was forced to make a "disgorgement" of those profits, in consent decree lingo. A subsequent shortage of one of the drugs led the FDA to ask a Genzyme competitor to offer its experimental treatment under an expanded access program.