plishments:The Orphan Drug Act has been a major success and a model federal program. The FDA has designated Fifteen years ago after its passage, more than 150 orphan drugs have been approved for marketing in the United States, and 800. Additionally, Japan, Singapore, and Australia have enacted orphan drug legislation, and the European Union is expected to enact a similar law in 1999. Approximately 85% of orphan drugs are treatments for diseases affecting fewer than 50,000 people in the United States, But there are about 200,000 people in the united states that are currently taking orphan drugs. The Problems:The major obstacle to development of many new orphan drugs is the lack of research funding available to the academic scientists who are studying orphan diseases. Congressional funding for the orphan drug research grants have hardly been sufficient to fund the number of worthy grant applications submitted by researchers to the FDA (as you will see later on the application is not very easily completed). In an effort to provide “seed money” to academic scientists, NORD is raising funds from the private sector to fund worthy clinical research projects to enhance development of new orphan therapies. At the same time, educational efforts aimed at familiarizing pharmaceutical manufacturers about orphan diseases are underway. Nevertheless, congress has appropriated only $12 million per year to the FDA’s Orphan Drug Grant Program, which is hardly enough to fund research on 5,000 rare disorders. How can the problems be solved?One or multiple combinations of the following items can solve the problems. Most people don’t know anything about orphan drugs. Maybe if the FDA or NORD made themselves more prominent in the eyes of the public about orphan drugs and the diseases that they treat, then NORD would get more money to give to the researchers. Since NORD and the FDA are already spending $12 million per year in 5,000 rare ...
