Orphan Drug Designation for AT001 in Autism

Professor Eric Hollander was awarded Orphan Drug Designation by the Office of Orphan Products Development of the Food & Drug Administration for the use of fluoxetine in the treatment of autism while at Mount Sinai School of Medicine .

The Orphan Drug Act (ODA) of January 1983, passed in the United States, with lobbying from the National Organization for Rare Disorders and many other organizations, is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market. Under the law, companies that develop such a drug may sell it without competition for seven years, and may get clinical trial tax incentives. Orphan drug designation means that the sponsor qualifies for certain benefits, such as reduced taxes, from the federal government.