Genzyme Expects Consent Decree With FDA May Cost $175 Million

Genzyme expects to finish negotiations in the next quarter with the FDA on a consent decree, which may cost the company $175 million and set up a time frame to move fill-finish operations out of its Allston, Mass., facility, which has been offline due to contamination. Draft provisions in the settlement include an additional 18.5 percent disgorgement of sales from products manufactured and distributed from Allston if the company does not meet deadlines for moving fill-finish processes out of the facility to two other plants.
Washington Drug Letter