Sunday, July 18, 2010

CSL ~ vaccine concern

nicola.roxon.mp@aph.gov.au
Dear Ms Roxon,

As Minister for Health and Ageing are you able to advise whether CSL has addressed the issue outlined to them in a letter from Mary A. Malarkey, Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, Food and Drug Administration, United States in June this year, regarding CSL non-compliance with good practice in the production of the 2009/2010 seasonal flu vaccine?
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm217293.htm
Given that CSL is seeking to expand its biotechnology business in Australia over the next five years and will no doubt be involved in providing vaccines, other therapies and medicines in the future, it is vital that consumers of these products be assured of the veracity of reporting and safety surrounding such production.
http://www.csl.com.au/s1/cs/auhq/1187378853299/news/1255924559119/prdetail.htm
Are you able to alleviate my (and others) concerns about possible contamination of the seasonal flu vaccine and whether this contamination affects public health in any way?

I look forward to hearing from you,

Kind regards,
Julie

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