Who decide? FDA approved medicine based on the clinical trial result. If the drug has good potency and has lesser side effect seen in clinical trial then FDA based on that approved the molecule for certain indication. If medical practitioner fined a new indication for that medicine then it has to be reported to the FDA with clinical data and for the safety and efficacy of that particular medicine. But the problem is health insurance company doesn’t paid to the off label indication except cancer medication. In chemotherapy, the treatment should be combination of the multiple drug for that they provide the insurance. Not all the off label drug for the other indication are come under health insurance. Types of off label drugs There are mainly two types of off label drugs: 1. Drug approved for one disorder and now it is used for completely different disorder. For example, if approved drug indication is for seizure but it’s off label indication is nerve pain. 2. Drug approved for one disorder and now it is used in the same disorder but for the different specification. Ethical side: There are some drugs which are approved for the one indication but that may also helpful in the …show more content…
The national comprehensive cancer network (NCCN) data shows that in US around 50% to 75% cancer drugs are off label. In simple way lung cancer are not like breast, leukaemia, kidney and colon cancer but they are physiologically same at the level of cell growth in the tumors. So the lung cancer drugs are may be useful in the other cancer. Other thing is sometimes the drug has broad activity for the several cancers but it might be approved for only one cancer so it is off label. So, due to this cancer drugs are come under the health insurance and it is widely accepted by the healthcare professionals. But there are some controversy regarding off label cancer drug. Controversy is because sometimes patient may also serve as guinea pig for unapproved of label indication for chemotherapy