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Recombinant Erythropoietin: Orphan Product with a Silver Spoon

Published online by Cambridge University Press:  10 March 2009

John M. Coster
John M. Coster
Affiliation:
U.S. Senate Special Committee on Aging
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Abstract

The U.S. Food and Drug Administration's (FDA) approval of the orphan biological product recombinant erythropoietin (rEPO) in June 1989 resulted both in a breakthrough treatment for the chronic anemia of people who suffer from chronic renal failure and a powerful argument for change in the legislation that spawned its development: the Orphan Drug Act of 1983. At a cost of over $6,000 per patient per year, Congress could not understand how a product that no manufacturer wanted to produce was suddenly costing the federal government hundreds of millions of dollars each year. Congress attempted to change the act in 1990 to preclude a manufacturer from using its provisions to secure lucrative monopolies in certain drug markets. In early 1991, the FDA finally issued regulations to implement the act that addressed some of the very concerns that were caused by rEPO.

Type
Special Section: Orphan Technologies
Information
International Journal of Technology Assessment in Health Care , Volume 8 , Issue 4 , Fall 1992 , pp. 635 - 646
Copyright
Copyright © Cambridge University Press 1992

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References

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