Page:United States Statutes at Large Volume 111 Part 3.djvu/278

 Ill STAT. 2366 PUBLIC LAW 105-115 —NOV. 21, 1997 "(4) the sponsor, or clinical investigator, of the investigational drug or investigational device submits to the Secretary a clinical protocol consistent with the provisions of section 505(i) or 520(g), including any regulations promulgated under section 505(i) or 520(g), describing the use of the investigational drug or investigational device in a single patient or a small group of patients. "(c) TREATMENT INVESTIGATIONAL NEW DRUG APPLICATIONS AND TREATMENT INVESTIGATIONAL DEVICE EXEMPTIONS. —Upon submission by a sponsor or a physician of a protocol intended to provide widespread access to an investigational drug or investigational device for eligible patients (referred to in this subsection as an 'expanded access protocol'), the Secretary shall permit such investigational drug or investigational device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if the Secretary determines that— "(1) under the treatment investigational new drug application or treatment investigational device exemption, the investigational drug or investigational device is intended for use in the diagnosis, monitoring, or treatment of a serious or immediately life-threatening disease or condition; "(2) there is no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat that stage of disease or condition in the population of patients to which the investigational drug or investigational device is intended to be administered; "(3)(A) the investigational drug or investigational device is under investigation in a controlled cUnical trial for the use described in paragraph (1) under an investigational drug application in effect under section 505(i) or investigational device exemption in effect under section 520(g); or "(B) all clinical trials necessary for approval of that use of the investigational drug or investigational device have been completed; "(4) the sponsor of the controlled clinical trials is actively pursuing marketing approval of the investigational drug or investigational device for the use described in paragraph (1) with due diligence; "(5) in the case of an investigational drug or investigational device described in paragraph (3)(A), the provision of the investigational drug or investigational device will not interfere with the enrollment of patients in ongoing clinical investigations under section 505(i) or 520(g); "(6) in the case of serious diseases, there is sufficient evidence of safety and effectiveness to support the use described in paragraph (1); and "(7) in the case of immediately life-threatening diseases, the available scientific evidence, taken as a whole, provides a reasonable basis to conclude that the investigational drug or investigational device may be effective for its intended use and would not expose patients to an unreasonable and significant risk of illness or injury. A protocol submitted under this subsection shall be subject to the provisions of section 505(i) or 520(g), including regulations promulgated under section 505(i) or 520(g). The Secretary may inform national, State, and local medical associations and societies,

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