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Genzyme Details Consent Decree

FDA sends Genzyme first draft of consent.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

During its quarterly earnings announcement, Genzyme provided details of the draft consent decree it received from FDA about the problems at its Allston site. Genzyme will pay $175 million from past profits. Also, if the fill/finish site continues operating after certain deadlines for products, the company will pay 18.5% of the revenues from sales of those products that were processed by the facility. If products are moved from the site but Allston’s problems are not remediated, Genzyme faces fines of $15,000 per day per violation until it is in compliance. The company reported that it is “actively negotiating” with the FDA on those terms.

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