目的：介绍美国罕见病药物制度。
对赛诺菲来说，这可能预示着麻烦，赛诺菲正要仰仗健赞的经验以获得蛋白治疗药物并进入罕见病药物市场。
This could portend trouble for sanofi, which is relying on Genzyme's expertise to strengthen its presence in protein-based therapies and the rare-diseases market.
方法：根据个人掌握的资料，说明美国罕见病药物制度形成的背景、有关法规、优惠措施及FDA审批程序。
Methods: The historical background formed American Orphan Drug system, regulation of Orphan Drug system, preferential measure, and FDA s approval procedure are stated.
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