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FDA, U.K. Medicines and Healthcare Products Regulatory Agency Working Collaboratively To Address Flu Vaccine Manufacturing Problems

ROCKVILLE, MD -- October 14, 2004 -- Today, the U.S. Food and Drug Administration (FDA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) announced their intent to continue in a cooperative effort to address the manufacturing quality concerns related to the production of Chiron's influenza vaccine, Fluvirin, at the company's Liverpool facility.

Regarding the ongoing joint effort, FDA Acting Commissioner Lester M. Crawford said, "The decision to work cooperatively to evaluate the scope of contamination and evidence presented in Chiron's investigation report is a significant positive step to understand fully what is at issue with influenza vaccines from Chiron's 2004 production. In addition, this effort will help to successfully address any significant issues before production for 2005 begins."

MHRA officials have been accompanying the FDA inspectors as observers in FDA's ongoing facility inspection of Chiron's plant. The inspection follows MHRA's September 28-30 inspection of the facility and subsequent announcement on October 5 to suspend Chiron's license.

MHRA Chief Executive Officer, Prof. Kent Woods, added "Contrary to some reported statements, MHRA, as the responsible regulatory authority in the United Kingdom, made the decision to suspend Chiron's license after an internal meeting on October 4 and first informed the company and the FDA of this decision on October 5. At the same time, we informed other drug regulatory authorities via an intergovernmental rapid information alert."

Chiron officials confirmed that they were first informed of the license suspension on October 5. A primary objective of the ongoing FDA investigation that commenced on October 10 is to evaluate Chiron's own internal investigation and findings concerning the contamination of some lots and its manufacturing quality systems related to assuring sterility of final vaccine product.

Source: The Food and Drug Administration

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