Mar. 31, 2004 –
A lawsuit alleges that pharmaceutical company Wyeth improperly trained employees, failed to comply with Food and Drug Administration standards, and kept lax records when producing the Prevnar vaccine, which protects children from pneumococcal meningitis, reports The Wall Street Journal.
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Before a vaccine was available the pneumococcal virus caused more than 700 cases of meningitis, a potentially fatal brain disease; 13,000 blood infections; and about 5 million ear infections a year, according to the Centers for Disease Control.
While the vaccine in question is still being administered to children, due to supply shortages infants are only able to receive the first two doses of the four-dose inoculation. The suit alleges that Wyeth’s failure to comply with standards was brought about by its rush to increase shipments of the lucrative vaccine.
However, the suit, brought by a former employee, is not concerned with the potential health risks caused by Wyeth’s alleged misconduct. Instead, it claims that Wyeth’s conduct amounted to fraud against shareholders when it concealed material problems with Prevnar production from investors.
An FDA spokeswoman told the Journal that the agency could not comment on ongoing litigation but said it "monitors companies closely for compliance with good manufacturing practices. When we become aware of any problems, we will follow up and take action as necessary."
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The company denies the allegations. "Training of employees at our Sanford site has never been a concern of the company or the FDA," a Wyeth spokesman says. "All employees working at the site have the requisite training, background and experience. In addition, there is no connection between our training obligations and requirements and the supply constraints currently affecting Prevnar."
