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Executive Summary

TROPICAL DISEASE ORPHAN DRUG DESIGNATION COULD BOOST INCENTIVES for drug and vaccine development, an Office of Technology Assessment (OTA) Oct. 1 report concludes. The report, entitled "Status of Biomedical Research and Related Technology for Tropical Diseases," suggests that Congress might consider "explicitly" including drugs and vaccines for tropical diseases in the definition of "orphan drugs" under the Orphan Drug Act. The recommendation is one of several "options" offered by OTA to enhance medical technology development and research funding for tropical illnesses. The Orphan Drug Act is currently administered by FDA under interim guidelines. According to an FDA official, proposed regulations may be issued for public comment by March. "The regulations, when final, could encourage research and development in drugs for tropical diseases," OTA observes. The report notes that in 1979, according to a Pharmaceutical Manufacturers Association estimate, 5%, or approximately $65 mil., of PMA member company R&D efforts were devoted to tropical diseases. Citing examples of pharmaceutical research, OTA notes that Roche has been investigating schistosomiasis for more than 20 years and has now focused attention on two compounds, one of which has been selected for clinical trials. In the area of leishmaniasis research, OTA says Squibb is reportedly supplying a compound to be tested in Africa and Burroughs-Wellcome is currently testing allopurinol. Seven PMA members companies have reported research projects in filariasis, OTA notes, including Parke-Davis, which was under contract to the World Health Organization for the synthesis of antifilarial drugs. Roche, Bayer, Ciba-Geigy, and Janssen have also been active in this research, the report states. According to OTA, Lederle, Sterling and Merck are reported to be conducting research in tuberculosis. Congress also might consider creating a "quasi-governmental nonprofit corporation" to support medical technology R&D for tropical illnesses until such technologies become "economically attractive" to private industry, OTA suggests. OTA says Congress could simply increase federal funding for all aspects of tropical disease research. However, the report does not identify specific funding programs or institutional bases for such increases. Under an alternative approach, Congress could amend the HHS "international health mandate" in order to remove "limitations on research" on tropical diseases which the agency may support, the report advises. The authority to undertake international research currently rests with the President, but Congress could transfer this authority to HHS, OTA explains. To aid its decisionmaking process, Congress might consider holding a "special-appropriations hearing" on tropical diseases with representatives from NIH, CUC, the Agriculture Department and other agencies and organizations, OTA continues. Each agency could be required to submit a report summarizing its activities on tropical disease research, it adds. The report was requested by the Senate Appropriations Committee. Copies are $11 each and may be obtained from the U.S. Government Printing Office, Superintendent of Documents, Washington, D.C. 20402. Request GPO stock number 052-003-00987-1.

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