의약품의 허가사항 외 사용으로 발생한 사고에 대한 의사와 제약회사의 책임

Off-label use is the practice of prescribing pharmaceuticals for a purpose outside the scope of a drug’s approved label-an unproven, untested use - most often concerning the drug’s indication. In Korea, The pharmaceutical affairs law permit physician and other healthcare practitioners to prescribe approved medications for other than their intended indications. Marketing information for the drug will list one or more indications, that is, illnesses or medical conditions for which the drug has been shown to be both safe and effective. Pharmaceutical companies are not allowed to promote a drug for any other purpose without formal KFDA approval. However, once a drug has been approved for sale for one purpose, physicians are free to prescribe it for any other purpose that on their professional judgment is both safe and effective, and are not limited to official, KFDA approved indications. Off-label use dose not have a discussion in korea but Off-label use of medication is very common. Some drugs are used more frequently off-label than for their original KFDA-approved indications. And, there is usually extensive medical literature to support the off-label use. This paper have a think about a background of a difference between the perception in medical and law. And this paper is studying liability of a doctor and pharmaceutical company.