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REVIEW & OUTLOOK (Editorial) Pazdur's Revenge
Wall Street Journal, 12-20-04

The Wall Street Journal notes that recent revelations about Vioxx and Celebrex have created a perfect storm where avaricious trial lawyers “have launched a campaign of unprecedented size and scope that threatens the R&D budgets not just of Merck but of the entire pharmaceutical industry.” Says one trial lawyer: “It’s not as big as asbestos and it’s not as big as tobacco but it’s number three.”

Meanwhile, “Congressional opportunists” and some bureaucrats at the FDA are using the controversy to “make it even harder for innovative therapies to get to market.” One of those bureaucrats is Richard Pazdur, “the FDA’s oncology (cancer) drugs chief,” who wants to slow down the fast-track approval process for new cancer drugs. “The faster approval concept was a response to protests from AIDS activists in the 1980s and was later extended to cover therapies for other terminal diseases.” The Journal says that the “Pazdur interpretation of the rule would effectively kill the accelerated approval process, since there are off-label therapies for just about everything.”

Project FDA.
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