Orphan Drug Program, By Terrell Herring

Market-based health care environments tend to encourage investment in pharmaceutical research and treatment of the most common conditions. With a larger patient base comes the likelihood of larger investment returns. While this advances the treatment of many illnesses, patients with less common conditions face limited treatment options. To correct this inequality, the U.S. Food and Drug Administration’s Office of Orphan Products Development (OOPD) sponsors research targeted to treating these conditions.

To qualify for the Orphan Drug Program, promoted by the OOPD, a medical condition must affect less than 200,000 individuals. In rare cases, when more than the limit of individuals are affected but drug companies do not estimate recouping research expenses, the Food and Drug Administration may waive the maximum patient requirement.

To date, the Office of Orphan Products Development is responsible for the production of 350 rare disorder treatments. The program has seen a 3,500% increase in available rare-disorder treatments since its inception in 1983.

About the Author: Terrell Herring, President of Mission Pharmaceutical, has actively supported the Orphan Drug Program through continued research on rare disease treatment.