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Wyeth DT Vaccine Seized By FDA; Manufacturing Upgrades Under Way

Executive Summary

Wyeth-Ayerst has been working on process improvements at its Marietta, Penn. plant for six months, the company said following a June 15 seizure action filed by FDA against products produced at the facility.

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Wyeth compliance program

Bruce Burlington, MD, will oversee the company's global QA/QC for all commercial products as senior VP-regulatory affairs & compliance, a newly created position. Burlington, who was director of FDA's Center for Devices & Radiological Health before joining Wyeth as VP-regulatory affairs in 1999, will now report to Wyeth Pharmaceuticals President Bernard Poussot, in addition to Wyeth Research President Patrick Gage, MD. Senior VP-QA/QC Roy Sturgeon, PhD, will report to Burlington. Sturgeon was directly under Poussot before the organizational change. Wyeth is currently in discussions with FDA to resume production at its Marietta, Penn. facility, after a seizure action by FDA against products manufactured there. Filling of Wyeth's flu vaccine Flushield has also been halted at the plant since December (1"The Pink Sheet" June 19, p. 29)

Wyeth compliance program

Bruce Burlington, MD, will oversee the company's global QA/QC for all commercial products as senior VP-regulatory affairs & compliance, a newly created position. Burlington, who was director of FDA's Center for Devices & Radiological Health before joining Wyeth as VP-regulatory affairs in 1999, will now report to Wyeth Pharmaceuticals President Bernard Poussot, in addition to Wyeth Research President Patrick Gage, MD. Senior VP-QA/QC Roy Sturgeon, PhD, will report to Burlington. Sturgeon was directly under Poussot before the organizational change. Wyeth is currently in discussions with FDA to resume production at its Marietta, Penn. facility, after a seizure action by FDA against products manufactured there. Filling of Wyeth's flu vaccine Flushield has also been halted at the plant since December (1"The Pink Sheet" June 19, p. 29)

Flu Vaccine Immunization Campaigns Should Be Delayed By One Month - ACIP

Health care organizations should delay their general influenza vaccination campaigns by a month for the 2000-2001 flu season due to anticipated delays in availability of vaccine or outright shortages, the Center for Disease Control & Prevention's Advisory Committee on Immunization Practices recommended at its June 21 meeting.

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