WASHINGTON Biotechnology Industry Organization president and chief executive officer Jim Greenwood issued the following statement last week to commemorate the 25th anniversary of the Orphan Drug Act: “This landmark law helped lead to the development of new drugs and biologics for rare and frequently untreated diseases by granting seven years of market exclusivity to the developer of a new therapy for a disease which affects less than 200,000 people in the U.S.”
He added that, “the law has led to a vast increase in the number of therapies available to the more than 25 million Americans living with one of the 7,000 recognized rare diseases and significantly contributed to the growth of the biotechnology industry.
The biotech industry has historically taken financial risks to develop therapies and cures to serve small patient populations suffering from rare, devastating diseases. The Orphan Drug Act established some necessary protection to attract the investment required to research and develop these breakthrough technologies.”
In the ten years before the Orphan Drug Act was signed into law, only ten new drugs were developed for rare diseases. In the past 25 years, the Food and Drug Administration has approved more than 300 drugs to treat orphan diseases.”