Navigation Links
Genzyme Corp. Signs Consent Decree to Correct Violations at Allston, Mass., Manufacturing Plant and Give up $175 Million in Profits

SILVER SPRING, Md., May 24 /PRNewswire-USNewswire/ -- Genzyme Corp. has signed a consent decree agreeing 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 U.S. Food and Drug Administration announced today.


Under the consent decree of permanent injunction, the Cambridge, Mass.-based company agreed to adhere to a strict timetable to bring the plant in line with the regulatory requirements of the FDA.

The payment is known as a disgorgement in which a company must give up profits obtained by improper or illegal acts.

The decree was agreed to by Genzyme, its Chief Executive Officer Henri A. Termeer; its Senior Vice President for Manufacturing Sciences and Technical Operations, W. Blair Okita; and its Senior Vice President for Global Product Quality, Ronald Branning. It was filed in the U.S. District Court for the District of Massachusetts on May 24, 2010, and is subject to court approval.

Genzyme is a sole supplier of several enzyme replacement drugs for injection that are used to treat rare genetic disorders. During an inspection of the Allston plant from Oct. 8, 2009, until Nov. 13, 2009, FDA inspectors found that the company's systems for ensuring manufacturing quality were inadequate resulting in production delays, critical shortages of medically necessary products to consumers and drugs contaminated with metal, fiber, rubber and glass particles. These manufacturing problems violated the FDA's regulations for manufacturing practice. Genzyme also temporarily suspended manufacturing of some products due to a viral contamination in a bioreactor that makes bulk amounts of its drugs. This resulted in additional drug shortages.

"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, M.D., FDA principal deputy commissioner.

Cerezyme, Fabrazyme, Myozyme, and Thyrogen are drug products that undergo all or some stages of manufacture at the Allston plant. Cerezyme treats Gaucher's disease, which causes fatty substances to accumulate in the liver, spleen and other organs. Fabrazyme treats Fabry disease, which prevents the body from breaking down oils and fats that build up in the eyes and the kidneys. Myozyme treats Pompe disease, a muscular disorder, and Thyrogen is used to diagnose thyroid cancer.

Genzyme has agreed to a work plan for making facility improvements. It begins with selecting, within 10 days of entry of the decree by the court, an independent expert who will inspect the plant and issue recommendations. Genzyme will use the expert's recommendations to create a work plan, subject to FDA approval, that requires specific steps for bringing its Allston plant into compliance within given dates. If Genzyme fails to complete any step specified in the work plan, the company will have to pay a substantial fine. In addition, the consent decree provides a deadline for Genzyme to transfer its operations for filling drug vials from its Allston facility to other manufacturing sites or else it will have to disgorge further profits from the sales of drugs filled at Allston after that specific date.

FDA is working with Genzyme during the company's remediation to ensure availability of the company's medically necessary drugs.  

Media Inquiries: Karen Riley, 301-796-4674;

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Genzyme Announces Second Pivotal Mozobil Trial Meets Primary Endpoint
2. Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis
3. Genzyme Completes Enrollment in Pivotal, Phase 2 Clinical Trial of Clofarabine in Adult AML
4. Genzyme Corporation Selects Diplomat Specialty Pharmacy for 2008 Renagel Medicare Part D Assistance Program
5. Genzyme Announces Presentation of New Positive Data on Carticel(R)
6. Genzyme Genetics Announces Launch of Carrier Testing and Prenatal Diagnosis for Spinal Muscular Atrophy
7. Preliminary Analyses from Phase 2 Genzyme Study Highlight Efficacy and Safety of Clofarabine in Older Adult AML Patients
8. Genzyme and Isis Complete Licensing of Mipomersen
9. Genzyme and Isis Begin Second Phase 3 Trial Of Mipomersen
10. Pain Relief in Just One Visit with Genzymes Synvisc-One
11. Webcast Alert: Isis Pharmaceuticals and Genzyme Corporation to Present Mipomersen Phase 3 Data in HoFH During AHA
Post Your Comments:
(Date:11/26/2015)... -- Research and Markets ( ) has announced the ... to 2019 - Rise in Cardiac Disorders and Growing Awareness ... their offering. Boston scientific ... scientific and others. --> The market is ... Boston scientific and others. ...
(Date:11/26/2015)... ) has ... Future Horizons and Growth Strategies in the ... Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> ) has announced the ... and Growth Strategies in the German Drugs ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 ... of the "Self Administration of High Viscosity ... ) has announced the addition of ... report to their offering. --> ... the addition of the "Self Administration of ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... 26, 2015 , ... Indosoft Inc., developer and distributor of the world-class Asterisk ... system efficiency and reliability. , The new Q-Suite 6 platform is based on the ... locking itself into a specific piece of software for many key components of the ...
(Date:11/25/2015)... ... November 25, 2015 , ... Medical Solutions, one of the ... stellar workplace culture with the company’s Cincinnati office being named a finalist among ... was named a finalist in Cincinnati Business Courier’s 13th annual Greater Cincinnati Best ...
(Date:11/25/2015)... ... ... For the first time, Vitalalert is donating half of its earnings to ... between the two groups began in 2014 with Vitalalert pledging a portion of every ... founded in 1954 and is an international Christian-based health organization whose mission is to ...
(Date:11/25/2015)... ... November 25, 2015 , ... Wimbledon Health Partners, ... new Wimbledon Athletics Facebook page to educate the public, parents and ... abnormalities. About 2,000 people under the age of 25 die from sudden cardiac ...
(Date:11/25/2015)... ... ... Beddit® has launched a new Android app for use with ... more intuitive SleepScore™ that rates sleep quality on a 100-point scale and makes it ... a proprietary algorithm. Beddit analyzes the data to provide an easy to understand scientific ...
Breaking Medicine News(10 mins):