Review of the legal issues of off-label drug usage / 中华医院管理杂志

ABSTRACT

This paper identified misunderstandings of the measures taken in China to overcome the problems incurred by off-label uses (namely reliance on drug makers to modify their medicine specifications,on medical institutions to enhance their regulation and management of off-label uses,and on informed consent to avoid risks).Based on such findings,the paper named defects found with such measures,and puts forward feasible ideas and methods to make such off-label uses legitimate and reasonable.These include clarification of the legal status of the medicine specifications,encouraging authoritative guidance for off-label uses,and determining the subject of evaluation to approve the off-label uses as reasonable.Such efforts aim at helping off-label uses out of the legal difficulties.