Thoene J G
Department of Pediatrics, University of Michigan Medical Center, Ann Arbor 48109-2029.
Curr Opin Pediatr. 1994 Apr;6(2):209-12. doi: 10.1097/00008480-199404000-00015.
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.
《孤儿药法案》成功刺激了许多针对孤儿疾病的孤儿产品的生产。其独家销售条款在将原本无利可图的产品推向市场方面的成功，引起了制造商的关注，他们利用这一条款为年销售额比原立法预期大得多的产品谋取垄断地位。一项旨在填补这一漏洞的修正立法正在准备提交国会审议。
