Genzyme signs consent decree with US FDA to correct violations at manufacturing plant and give up $175 million in profits

Troubled US biotechnology firm Genzyme has signed a consent decree agreeing to correct manufacturing quality violations at its Allston, Massachusetts, manufacturing facility and will turn over to the federal government $175 million in 'unlawful profits' from the sale of products that were made at the plant, the Food and Drug Administration announced yesterday.

'It is critical for the safety of the drug supply that companies comply with basic manufacturing standards. FDA takes these obligations very seriously and expects manufacturers to do the same,' said Joshua Sharfstein, FDA Principal Deputy Commissioner.

The news of the fine came as no surprise, because Genzyme has already warned that it was expected along with announcing first-quarter financial results (The Pharma Letter April 22), but it still saw the shares of the maker of drugs for rare diseases fall 1.9% to $48.48 yesterday. The manufacturing, and resultant supply problems have already cost the company dearly in lost sales of its leading drugs.