title: Recombinant erythropoietin. Orphan product with a silver spoon.
abstract: The U.S. Food and Drug Administration's (FDA) approval to 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.
authors: J M
authors: JM
authors: Coster
mesh_terms: D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D017277:Drug Approval; D004921:Erythropoietin / Q000191:economics / Q000627:therapeutic use; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications; D009965:Orphan Drug Production / Q000331:legislation & jurisprudence; D010330:Patents as Topic; D011994:Recombinant Proteins / Q000191:economics / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D011994:Recombinant Proteins; D004921:Erythropoietin