FDA Names Orphan Products Development Head

The U.S. Food and Drug Administration has named Dr. Timothy Cote as director of its Office of Orphan Products Development.

Cote will be responsible for promoting the development of products that demonstrate promise for the diagnosis or treatment of rare diseases or conditions.

A captain in the U.S. Public Health Service Commissioned Corps, Cote most recently served as the Centers for Disease Control’s country director for the African nation of Rwanda. In Rwanda, he directed programs in HIV/AIDS, malaria and avian influenza, and was responsible for scientific and administrative leadership in patient care and research initiatives.

Cote — who succeeds Dr. Debra Lewis, the office’s acting director — previously served as a CDC epidemic intelligence officer at the Maryland Health Department and as chief of the therapeutics and blood safety branch in the FDA’s Center for Biologics Evaluation and Research.

The orphan drug program provides a seven-year exclusive right for a pharmaceutical company to market a drug designed to treat a disease that afflicts fewer than 200,000 people in the United States.