PINL:GRPOF - Post by User
Post by
ScienceGirlon Mar 26, 2018 2:17pm
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Post# 27783074
Orphan drug status - what it means
Orphan drug status - what it means
It means that the drug has been deemed "SAFE" by the FDA for a rare disease. However, drugs can also be prescribed off label (AS IN FOR ANY PAIN AS AN EXAMPLE), which sometimes also gets covered by insurance. Bottom line, DOCTORS CAN PRESCRIBE RX PRINCEPS IN THE USA. Never mind it is for a rare disease, they can prescribe for anything they wish based on their professional opinion. TBP management executed brilliantly, getting that expedited approval via orphan drug status to get doctors used to prescribing this ASAP and get the word out to doctors. They entered the market through the back door and jumped the line to be the first.