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Patent Holder Does Not Want to Market Drug in USA

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There is a nice piece in today's WSJ [subscription required] on Omegaven, a new drug approved for use in Europe but (gee, this has never happened before, has it?) not in the USA.

It turns out the drug shows promise in helping children with "short bowel syndrome." These children can't absorb enough nutrients from food, and some need intravenous feedings to survive. For reasons not fully understood, children put on intravenous nutrition may suffer liver damage. Some require liver and small bowel transplants, risky procedures that don't always work. Others die waiting for a transplant.

In July 2006, in a paper in Pediatrics, researchers at Children's Hospital in Boston reported on a potentially promising treatment. They found that by switching from the standard intravenous formula to Omegaven, babies weren't progressing to liver failure. Trouble is, the German company that developed Omegaven, Fresenius Kabi AG, says it isn't interested in bringing the drug to the U.S. market. It has an even better drug in the pipeline, and cannot afford the cost of getting two drugs approved by the FDA.

The drug can be procured in Europe, of course, but not with Fresenius Kabi's help -- for that would be inviting punitive damages if an unapproved drug were to be promoted stateside.

Meanwhile, little children are dying.

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.