Organizations around the world observed February 29, 2012, as the fifth annual Rare Disease Day. The Food and Drug Administration (FDA) supported Rare Disease Day and the global effort to raise awareness about rare diseases, the importance of research to develop diagnostics and treatments, and the challenges faced by patients with rare diseases and their families on a daily basis.

Held on the last day of February—Feb. 29 in leap years and Feb. 28 in other years—Rare Disease Day 2012 focussed on solidarity and the need for collaboration as well as mutual support in the field of rare diseases, with the theme being “Rare but strong together”.

Rare disease is defined differently around the globe. About 7,000 known rare diseases have been identified around the world. In the United States, a disease is rare if it affects fewer than 200,000 people. 

About 30 million Americans are afflicted with rare diseases. Each disease has unique problems and may have little or no support or treatment. 

It is estimated that about 80 percent of rare diseases are genetic, and about half of all rare diseases affect children. When the Orphan Drug Act (ODA) of 1983 was signed into law, no one could have imagined then that it would become one of the most important pieces of health care legislation today. 

More than 390 orphan products for treatment of rare diseases have been approved by FDA since this groundbreaking legislation went into effect.