FDA Promotes Drugs For Rare Diseases

FDA has awarded 15 grants worth a total of $14 million to accelerate the development of drugs for rare diseases. A disease is considered rare in the U.S. if it affects fewer than 200,000 people. The grants will be administered through FDA’s Orphan Products Grants Program, created by the Orphan Drug Act of 1983. To date, the program has provided more than $300 million to fund hundreds of clinical studies related to treatments for rare diseases and has led to the approval of dozens of drugs. “FDA is committed to fostering and encouraging the development of products for rare diseases, most of which have no available or adequate treatments,” says Gayatri R. Rao, director of FDA’s Office of Orphan Products Development. There are about 6,800 rare diseases, and nearly 30 million Americans are afflicted with at least one of them, according to NIH.