Amid ongoing scrutiny of rising prescription drug costs, a three decade-old law has become a new flash point in the back-and-forth debate that continues to roil the industry.
The 1983 Orphan Drug Act was designed to encourage drug manufacturers to develop new medicines for smaller, neglected diseases that didn’t offer as much of a financial return. Along with tax credits and other benefits, the law granted drugmakers who secured approval of a rare disease drug seven years of marketing exclusivity — a powerful monopoly.
