What is the name of the 1983 law providing incentives for orphan drug development?

• A. Orphan Drugs
• B. Expedited Approval
• C. Benoxaprofen
• D. Orphan Drug Act

Answer: (D)

The concept here is recognizing a law created to encourage development of treatments for rare diseases by offering substantial incentives. The name of that 1983 law is the Orphan Drug Act. It established programs and benefits like seven-year market exclusivity for approved orphan drugs, tax credits for qualified clinical testing, grants to support development, and fee waivers to help small companies bring these therapies to market. It also set up a formal designation process and created the Office of Orphan Products Development to promote work on rare conditions. The other options aren’t the name of the law: one is just a generic phrase, another refers to a regulatory pathway, and the last is a specific drug rather than legislation.