Dr. Marlene Haffner was the Director of the Office of Orphan Products Development at the Food and Drug Administration (FDA) for 20+ years. During her tenure in that program, it became THE orphan products program in the world. In addition to assisting in the development of more than 300 products in the US she is credited with assisting in the development of programs in Japan, the European Union, Australia, and beyond. Her extensive speaking and writing brought the term “orphan products” to the mind of many in the pharmaceutical world.