Genzyme Meets Consent Decree Deadline - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Genzyme Meets Consent Decree Deadline


ePT--the Electronic Newsletter of Pharmaceutical Technology

On Nov. 24, 2010, Genzyme (Cambridge, MA) officially ended fill–finish operations at its Allston Landing, Massachusetts, plant for products sold in the United States, thereby fulfilling a requirement of a US Food and Drug Administration consent decree. Genzyme has transferred all fill–finish activities for its Cerezyme (imiglucerase for injection), Myozyme (alglucosidase alfa), Fabrazyme (agalsidase beta), and Thyrogen (thyrotropin alfa for injection) products for the US market to its Waterford, Ireland, plant and to a third-party contract manufacturer. This change effectively lifts all previous restrictions on the company’s marketing and distribution of Thyrogen within the United States.

The consent decree requires Genzyme to end all remaining fill–finish activities in Allston Landing for products sold outside of the United States by August 31, 2011. Genzyme is cooperating with regulatory authorities to achieve this goal.

During an inspection of the Allston Landing plant from Oct. 8, 2009 to Nov. 13, 2009, FDA inspectors concluded that Genzyme’s systems for ensuring manufacturing quality were inadequate, thus causing production delays, critical shortages of medically necessary products, and contamination. The plant’s manufacturing problems violated FDA’s regulations for good manufacturing practice, according to the agency. The consent decree, which Genzyme signed in May 2010, requires the company to correct manufacturing-quality violations at the plant.

FDA required Genzyme to draft a remediation plan that includes ongoing oversight from Quantic, the company’s third-party consultant. If remediation actions are not complete by certain milestones, Genzyme must pay FDA $15,000 per day per affected drug until the compliance milestones are met. After the remediation plan has been completed, Quantic will oversee Genzyme for five years and submit annual reports to the agency. Genzyme expects that the remediation plan will require approximately two to three years to complete.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
26%
Oversee medical treatment of patients in the US.
13%
Provide treatment for patients globally.
11%
All of the above.
39%
No government involvement in patient treatment or drug development.
11%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here