ABSTRACT
In January 1983, when the Orphan Drug Act1 was signed into law in the U.S. by President Ronald Reagan, incentives were for the first time provided for the pharmaceutical industry to develop drugs that otherwise have little commercial value but which are necessary, and at times life-saving, for patients with rare diseases. A 1984 amendment defined applicable rare diseases as those affecting fewer than 200,000 patients in the U.S. Products (known as orphan products) to treat these populations include drugs and biologicals which, despite potential usefulness, remain inadequately tested and/or unavailable to patients due to the limited commercial interest.
