There are special rules for certain rare diseases ("orphan diseases") in several major drug regulatory territories. For example, diseases involving fewer than 200,000 patients in the United States, or larger populations in certain circumstances are subject to the Orphan Drug Act.  Because medical research and development of drugs to treat such diseases is financially disadvantageous, companies that do so are rewarded with tax reductions, fee waivers, and market exclusivity on that drug for a limited time (seven years), regardless of whether the drug is protected by patents. COUNT 7
QSN1 What is subject to the Orphan Drug Act? ANS1 diseases involving fewer than 200,000 patients in the United States, or larger populations in certain circumstances QSN2 What is given to companies who develop drugs for "orphan diseases"? ANS2 tax reductions, fee waivers, and market exclusivity on that drug for a limited time (seven years), regardless of whether the drug is protected by patents QSN3 Why are these companies rewarded? ANS3 Because medical research and development of drugs to treat such diseases is financially disadvantageous QSN4 What size of disease populations are subject to the Orphan Drug Act? ANS4 fewer than 200,000 patients QSN5 What is one financial benefit to researching orphan drugs? ANS5 tax reductions QSN6 What is the length of time of market exclusivity of an orphan drug? ANS6 seven years QSN7 What is a term for rare diseases in some territories? ANS7 orphan diseases