Study On The Right To Try Act On Drugs In Clinical Trials In The United States

On May 31,2018,the United States passed a new bill on drugs in clinical trials,which is known as the "Right to Try" Act.The gist of this act is to allow eligible patients to use new drugs under research that have passed the first phase of clinical trials without the approval of the U.S.Food and Drug Administration(FDA).The "Right to Try" Act circumvents the prior approval of FDA,and therefore has caused great controversy in the United States as well as many discussions in the American society and medical and pharmaceutical industry.However,the information of the Right to Try is very limited in China and therefore the research on the Right to Try Act is of certain significance to China’s drug regulation.This paper reviews the development history of drug regulation in the United States by summarizing the relevant legislative documents,domestic and foreign literature and relevant cases of the Right to Try.It focuses on two measures of FDA to adjust and change in response to regulatory challenges under the new situation,and summarizes the relationship between drug regulation and drug crisis and patients’ health needs in the United States.Based on the review of the history and changes of drug regulation in the United States,this paper introduces the legislative process and background of Right to Try,analyzes its content clause by clause,and compares the Right to Try with two similar types of drug use,i.e.,the Expanded Access and the Off-label Uses to discover their differences,so as to better understand the features of the Right to Try.Finally,through the relevant case analysis,this paper further generalizes experiences drawn from the Right to Try and point outs challenges currently confronting the U.S,in order to give the relevant enlightenment and suggestions of drug regulation in China.The Right to Try Act of the United States is a phased result of the game balance between the protection of patients’ rights and interests and drug regulation.To some extent,the Right to Try is a continuation of the existing channels of Expanded Access.It is a new breakthrough and challenge for drug regulation that the Right to Try Act bypasses the approval of FDA to obtain new drugs for clinical trials.As the Right to Try Act has not been implemented for a long time,pharmaceutical companies have not disclosed annual reports as required by this act,and the actual effect and consequence of the Right to Try Act still needs further study.