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REVIEW & OUTLOOK (Editorial): How About a 'Kianna's Law'?
Wall Street Journal, 3-24-05

The Wall Street Journal captures one side of the drug safety issue that seldom receives attention outside of industry circles: how the FDA’s obsession with amassing reams of redundant data costs lives.

The Journal highlights the predicament of a single kidney-cancer patient who is dying while the FDA denies her access to treatments for her disease.

What makes Mrs. Karnes’s predicament so depressing is that two different developmental drugs have shown great promise for several years now against this once near-untreatable disease. But not only has the Food and Drug Administration not moved with dispatch to approve the drugs, it has begun imposing new testing requirements that make it all but impossible for their developers – Bayer and Pfizer – to provide them to terminal patients on a ‘compassionate use’ basis.”

Project FDA.
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