Wyeth compliance program

Executive Summary

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)