Page:United States Statutes at Large Volume 111 Part 3.djvu/277

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2365 (A) IN GENERAL. —The Secretary shall request the Institute of Medicine of the National Academy of Sciences to conduct the study required by paragraph (2), and to prepare and submit the report required by subparagraph (B), under an arrangement by which the actual expenses incurred by the Institute of Medicine in conducting the study and preparing the report will be paid by the Secretary. If the Institute of Medicine is unwilling to conduct the study under such an arrangement, the Comptroller General of the United States shall conduct such study. (B) REPORT.— Not later than September 30, 2005, the Institute of Medicine or the Comptroller General of the United States, as appropriate, shall prepare and submit to the Committee on Labor and Human Resources of the Senate, the Committee on Commerce of the House of Representatives, and the Secretary a report of the results of the study required by paragraph (2). The Secretary, after the receipt of the report, shall make the report available to the public. SEC. 402. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES AND DIAGNOSTICS. Chapter V (21 U.S.C. 351 et seq.), as amended in section 401, is further amended by adding at the end the following: "SUBCHAPTER E—GENERAL PROVISIONS RELATING TO DRUGS AND DEVICES "SEC. 561. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND 21 USC 360BBB. DIAGNOSTICS. "(a) EMERGENCY SITUATIONS.— The Secretary may, under appropriate conditions determined by the Secretary, authorize the shipment of investigational drugs or investigational devices for the diagnosis, monitoring, or treatment of a serious disease or condition in emergency situations. " (b) INDIVIDUAL PATIENT ACCESS TO INVESTIGATIONAL PROD- UCTS INTENDED FOR SERIOUS DISEASES.— Any person, acting through a physician licensed in accordance with State law, may request from a manufacturer or distributor, and any manufacturer or distributor may, after complying with the provisions of this subsection, provide to such physician an investigational drug or investigational device for the diagnosis, monitoring, or treatment of a serious disease or condition if— "(1) the licensed physician determines that the person has no comparable or satisfactory alternative therapy available to diagnose, monitor, or treat the disease or condition involved, and that the probable risk to the person from the investigational drug or investigational device is not greater than the probable risk from the disease or condition; "(2) the Secretary determines that there is sufficient evidence of safety and effectiveness to support the use of the investigational drug or investigational device in the case described in paragraph (1); "(3) the Secretary determines that provision of the investigational drug or investigational device will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval; and

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