August 13, 2003 | The FDA has designated more than 1,000 orphan products and approved more than 200 for marketing. Approval time for orphan products has historically been "considerably shorter" than for other drugs, the FDA says, because many are for treatment of life-threatening diseases. Sponsors of orphan drugs receive certain benefits from the government in exchange for developing them, such as tax credits.
Some of the rare diseases now treated by orphan drugs:
· Cystic fibrosis
· Sickle cell anemia
· Huntington's disease
· T-cell lymphoma
· Hansen's disease
· Juvenile rheumatoid arthritis
For more information
FDA Office of Orphan Products Development
National Organization for Rare Disorders
Office of Rare Diseases, NIH
Back to Orphan Drugs: For Love or Money?