Please login to the form below

Not currently logged in
Email:
Password:

Genzyme pays regulators $175m

Genzyme has agreed to pay $175m to federal regulators in connection with manufacturing problems at its Allston Landing facility in Boston, US

Genzyme has agreed to pay $175m to federal regulators in connection with long-standing manufacturing problems at its Allston Landing facility in Boston, US.

The payment is the return of 'unlawful profits' from the sale of products made at the plant, the US Food and Drug Administration (FDA) said in a statement.

As part of the agreement, Genzyme must transfer the fill/finish process for drugs manufactured at its Allston plant to other manufacturing sites within specified deadlines, or face losing 18.5 per cent of revenue received from selling products made there.

Additionally, if Genzyme fails to comply with manufacturing standards over the next few years, it will have to pay £15,000 per day until it meets federal standards.

The remediation process is expected to take between two and three years to compete. Upon completion, the FDA will require five years of oversight and annual reports submitted by a third-party contractor.

FDA principal deputy commissioner Joshua Sharfstein said: "It is critical for the safety of the drug supply that companies comply with basic manufacturing standards. The FDA takes these obligations very seriously and expects manufacturers to do the same."

The long-standing manufacturing problems have already cost Genzyme millions. In June, the plant was shut down for three months to clean up a viral contamination. Although the virus was not harmful, the shutdown was costly. During the fourth quarter, profits plunged 73 per cent to £23.2m on lower sales.

25th May 2010

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
11 London

The biggest problems facing humanity today are health-related, and the health of people, animals and our planet are inextricably linked. ...

Latest intelligence

JulAug cover image
The Chronicles of Pharma: a creative review of pharma’s journey to omnichannel
Chris Ross conducts a literary-inspired review of pharma’s pursuit of communications excellence...
The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor
Powerful therapies that can improve skin clarity dominate the psoriasis landscape, so why are most patients stuck in a cycle of ineffective topicals? Fishawack Health explores the market and reveals...
Virtual Speaker Program: A Customer Story
Learn how we helped our client develop a virtual speaker program and roll out a series of regional peer-to-peer education sessions....