US Orphan Drug Program: Global Reference Point

The Orphan Drug Act has become a staple of Food and Drug Law in the USAand acts as a reference point for international initiatives, according to a recent study by the Boston-based Tufts Center For The Study Of Drug Development, which provides an overview of orphan drug activity in the USA since its inception in 1983 to 1995.

The survey notes that the US initiative has been widely applauded both domestically and internationally, where it has served as a prototype for the orphan drug program in Japan, which was initiated in October 1993. It also provides the guidelines for the European Commission's draft Council Regulation on orphan medicinal products, the most recent version of which was distributed for discussion in February this year.

More recently, the Australian government has announced that, following US marketing approval for an orphan drug, Australia will automatically approve the drug for the same indication where the prevalence of the condition among the population is no more than 1 in 5,000.