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Current status of orphan disease drug development.

Author(s): Thoene JG

Affiliation(s): Department of Pediatrics, University of Michigan Medical Center, Ann Arbor 48109-2029.

Publication date & source: 1994-04, Curr Opin Pediatr., 6(2):209-12.

Publication type: Review

The Orphan Drug Act has successfully stimulated the production of many orphan products for a number of orphan diseases. The success of its exclusive marketing provision in bringing otherwise unprofitable products to market has attracted the attention of manufacturers who use this provision to gain a monopoly for products with much larger annual sales than were contemplated by the original legislation. Corrective legislation to close this loophole is being prepared for introduction to Congress.

Page last updated: 2006-01-31

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