title: Orphan Drug Act on congressional agenda.
abstract: In 1983, Congress passed the Orphan Drug Act to encourage development of pharmaceuticals used in the treatment or diagnosis of diseases that occur so rarely that there is no financial incentive for development of these so-called "orphan drugs." The Act established, among other things, exclusive marketing rights on unpatentable orphan drugs for a period of seven years and a tax credit equal to 50 percent of the cost of conducting human clinical trials. It also authorized the Secretary of Health and Human Services (HHS) to make grants and enter into contracts to reduce the costs of clinical testing in orphan drug development.
mesh_terms: D004345:Drug Industry; D007880:Legislation, Drug; D009965:Orphan Drug Production; D012109:Research Support as Topic / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration