▁O DA ▁or phan ▁drug ▁spons ors ▁qual ify ▁for ▁seven - year ▁F DA - admin ister ed ▁market ▁Or phan ▁D rug ▁Ex clus ivity ▁( O DE ), ▁" tax ▁cred its ▁of ▁up ▁to ▁ 5 0 % ▁of ▁R & D ▁costs , ▁R & D ▁gr ants , ▁wa ived ▁F DA ▁fe es , ▁protocol ▁assistance ▁and ▁may ▁get ▁clin ical ▁trial ▁tax ▁in cent ives . ▁ ▁In ▁the ▁U . S ., ▁or phan ▁drug ▁design ation ▁means ▁that ▁the ▁spons or ▁qual ifies ▁for ▁certain ▁benefits , ▁but ▁it ▁does ▁not ▁mean ▁the ▁drug ▁is ▁safe , ▁effective ▁or ▁legal . ▁ ▁In ▁ 2 0 0 2 , ▁the ▁R are ▁D ise ases ▁Act ▁was ▁signed ▁into ▁law . ▁It ▁am ended ▁the ▁Public ▁Health ▁Service ▁Act ▁to ▁establish ▁the ▁Office ▁of ▁R are ▁D ise ases . ▁It ▁also ▁increased ▁fund ing ▁for ▁the ▁development ▁of ▁treat ments ▁for ▁people ▁with ▁rare ▁dise ases . ▁ ▁European ▁Union ▁In ▁ 2 0 0 0 , ▁the ▁European ▁Union ▁( E U ) ▁en act ed ▁similar ▁legisl ation , ▁Reg ulation ( EC ) ▁No ▁ 1 4 1 / 2 0 0 0 , ▁which ▁refers ▁to ▁dru gs ▁developed ▁to ▁treat ▁rare ▁dise ases ▁to ▁as ▁" orph an ▁medic inal ▁products ". ▁The ▁EU ' s ▁definition ▁of ▁an ▁or phan ▁condition ▁is ▁bro ader ▁than ▁that ▁of ▁the ▁USA , ▁in ▁that ▁it ▁also ▁covers ▁some