Genzyme Could Pay $175 Million as Part of FDA Sanction

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 had been offline due to contamination.

The company expects to pay $175 million in past profits upfront as part of the decree, Genzyme said last month. 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 to two other plants.

Another provision in the draft decree would levy a $15,000-per-day fine if deadlines in a compliance remediation plan, to be approved by the agency, are not met, Genzyme said.
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