Orphan Drug Designation
An orphan drug designation is a specific designation given to a type of drug by the FDA. The FDA grants this destination to certain types of drugs to encourage people to pursue treatment options for diseases that impact a very low number of people, preventing them from being “orphaned,” or overlooked. An orphan drug designation is usually given to a drug that treats a condition that impacts fewer than one out of every 200,000 people in the United States. Drugs that received this designation are eligible for a wide variety of incentives including qualified clinical trials and tax credits. The goal of the program is to spur research into treatment options for diseases that are traditionally overlooked.