| 英文摘要 |
“Expanded access”, also known as “compassionate use”, refers to a patient suffering from a serious or threatening life disease or a terminal patient would access to a promising investigational new drug (IND) which has not yet been approved to market, to treat or cure his/her disease when there is no comparable or alternative option of treatment. The legislation on drug regulation established by the United States in 1962, requires the applicant should submit the substantial evidence to demonstrate the safety and effectiveness of the drug before the approval of drug marketing. The FDA has established a strict standard of the clinical trial, conducted adequate and well-controlled investigations, in a maner of randomized, double-blinded, placebo-controlled trial, and by scientific and medical judgment to verify and evaluate the safety and effectiveness of IND and to ensure the safety and health of the public. However, it takes 10 to 15 years for a new drug from development to being approved to market, to make hundreds of thousands or even millions of patient suffering from serious, life-threatening and terminal patient without any medicine to save their plight, and died in despair. In response to the special needs of said patients, the Congress and FDA had to create exceptionally the legislation of expanded access to use the IND to mitigate the strict relugatory system of drugs. Even the Patient Alliance was still further litigation to the federal court, and the states then engaged in the Right to Try legislation to protect the patients to obtain a right of access to experimental drugs that have passed the first phase of clinical trials. The legislation of expanded access to the unapproved IND explored by this article is to discuss the legal system of United States as a core, including the history of legislation on drug regulation in the United States, the overview of the process of application for the IND, to elaborate the evolution, standard, category of the legislation of expanded access to the IND, and to analyze the interests of the involved parties and the lacks of operation in the practical aspects, and the patients and the states try to challenge the legislation of expanded access to the IND. This article is limited by space, only “drugs” for the scope of discussion, medical devices and biological products would be omitted temporarily. |
