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."
This represents about 55% of the total market for childhood vaccines. After the CDC added the chicken pox and Prevnar vaccines to the program, the VFC budget rose from $500 million in 2000, to over $1 billion in 2002.
In 2004, it became the first vaccine to top $1 billion in yearly sales, mainly because it costs more than $220 per 4-shot regimen and the "federal government recommends Prevnar and pays a good price for it -- as do private purchasers," according to the November 9, 2005 Wall Street Journal.
And sales have continued to increase each year. According to Wyeth's first quarter earnings report for 2005, Prevnar achieved net revenues of $391 million, or more than double the first quarter earnings reported in 2004. And the company's first quarter earning report for 2006, show that Prevnar sales rose another 10% to $432 million so far this year.
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."
Which Livingston says amounted to 20 million plus does per year on a consistent basis.
In just 3 years, the plant's employment numbers went from 300 employees to over 1200, he says, and providing proper training to that number of new employees would be impossible. "Because of the complex nature of biological vaccine manufacturing," he explained, "basic training for front-line employees took 12 months."
According to Livingston, "repeated quality audits in 2000, 2001, and 2002 revealed noncompliance with corporate and FDA regulatory standards."
As it turns out, his prediction that vaccines production could be halted came true and was revealed in February 2004, when Wyeth came up short of Prevnar. In less than 4 months, the CDC, had to issue two advisories relating to the rationing of Prevnar.
Publicly, Wyeth claimed that the supply was hampered by unspecified production problems. However, many doctors were upset when they learned about the extent of the manufacturing problems that led the shortage and that Wyeth had been cited by the FDA for manufacturing violations again and again in the years before the shortage occurred.
For instance, Wyeth failed to reveal that in 2003, FDA inspectors found so many quality-control failings at the Prevnar packaging plant in Pearl River, NY, that production was shutdown at the site.
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