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.
|