WASHINGTON, May 24 (UPI) — U.S. officials announced Monday the Genzyme Corp. has agreed to correct drug manufacturing violations and will give up $175 million in profits.
The U.S. Food and Drug Administration said the company agreed to correct manufacturing quality violations at its Allston, Mass., 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 FDA said the payment is known as a disgorgement, by which a company must give up profits obtained through improper or illegal acts.
The decree was signed by Genzyme Chief Executive Officer Henri Termeer, Senior Vice President for Manufacturing Sciences and Technical Operations W. Blair Okita and Senior Vice President for Global Product Quality Ronald Branning.
The consent decree, filed Monday in federal court in Boston, is subject to court approval.
Genzyme is a sole supplier of several enzyme replacement drugs used to treat rare genetic disorders. During an inspection of the Allston plant late last year, FDA inspectors found the company’s systems for ensuring manufacturing quality were inadequate resulting in production delays, critical shortages of medically necessary products and drugs contaminated with metal, fiber, rubber and glass particles.
The plant manufactures the drugs Cerezyme, Fabrazyme, Myozyme and Thyrogen.
Copyright 2010 United Press International, Inc. (UPI). Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI’s prior written consent.