A Sarbanes-Oxley Act (SOX) action against Wyeth, is currently underway in a North Carolina involving Mark Livingston, a former associate director of training at a Wyeth vaccine manufacturing plant in North Carolina.
Livingstone says he was fired for raising concerns that vaccine production employees were not properly trained, in violation of FDA regulations, and a consent decree previously imposed on Wyeth by the FDA.
Wyeth denies his allegations that employees were not properly trained, but says even if they are true, Livington's reporting of concerns that vaccine production employees were not properly trained, in violation of FDA regulations, is not a protected activity unless the rules relate to a direct fraud against shareholders.
Wyeth hired Livingston in 2000 to help in the introduction of Prevnar, a new vaccine designed to fight pneumoccocal pneumonia and meningitis in infants. The facility where he worked was the vaccine's only production site.
One of Livingston's responsibilities was to assure manufacturing compliance through quality training and he discovered serious deficiencies in training as soon as he arrived.
"When I got to the Wyeth vaccine plant in August 2000," he said, "they had a part-time nurse delivering safety training to new hires."
An occupational health and safety specialist was not hired until February 2001, a full year after Prevnar was approved by the FDA, he says. "And this occurred only after the October 2000 consent decree for ongoing manufacturing violations," he adds.
A consent decree results when a company repeatedly fails to comply with FDA standards.
The FDA announced a consent decree after inspectors determined that Wyeth plants were not meeting manufacturing standards in New York and Pennsylvania. As part of a settlement, Wyeth agreed to pay $30 million, and to hire experts to conduct an all-inclusive inspection of the plants and to certify overall quality efforts.
"This occurred," Livingston said, "after realization by Wyeth executives that they had a blockbuster pediatric vaccine on their hands and no one had bothered to do any planning for staff additions in the next several years."
According to Livingston, once Prevnar was added to the childhood vaccine schedule, Wyeth was caught totally unprepared, and as it attempted to meet the skyrocketing demand for Prevnar, "large numbers of new employees with limited backgrounds in vaccine production were being hired."
"Despite the presence of PhD's and MBA's out the wazoo," he said, "no one in the marketing or research departments at Wyeth ever bothered to call the supply chain folks up and ask if they could produce the vaccine in the amounts they wanted."
Read much more here by investigative journalist Evelyn Pringle
No comments:
Post a Comment