WASHINGTON _ The Office of Science and Technology Policy(OSTP) has proposed establishing a National Bioethics AdvisoryCommission (NBAC) to consider issues surrounding the use of geneticinformation and protection of the rights and welfare of researchsubjects.The commission would make recommendations directly to the NationalScience and Technology Council (NSTC), a cabinet-level body chairedby President Clinton."The Commission would be asked to identify and develop broadoverarching principles to govern the ethical conduct of biological andbehavioral research and the application of that research," stated anotice in the Federal Register. The commission would not review orapprove individual projects.Other issues to be considered by the NBAC would include geneticprivacy, screening for genetic disorders, intellectual property rights,access to research data or materials developed with public funding,current views on informed consent documents used in clinical trials andthe adequacy and implementation of Federal human subject researchguidelines.In addition, the proposed NBAC could make recommendations onrequirements to maintain research data and "the ethical aspects ofaccess to costly health care technology."The NBAC will be composed of 15 members appointed by thepresident with at least one member from each of the following areas ofexpertise: bioethics/theology; social/behavioral science; law;medicine/allied health professions; and biological research. In addition,at least three members of the general public with relevant expertise inother areas will serve on the commission. The NBAC could hold publicmeetings up to 10 times a year and will issue an annual report to theNSTC and appropriate committees of Congress.The NBAC would expand work currently being done by the NationalCommission for the Protection of Human Subjects of Biomedical andBehavioral Research, the Department of Health, Education andWelfare's Ethics Advisory Board, and the President's Commission forthe Study of Ethics Problems in Medicine and Biomedical andBehavioral Research.The OSTP is currently seeking public comments on the draft charterfor the NBAC that appeared in the Aug. 12 Federal Register (pp.41584-41586). For further information, contact Rachel Levinson,assistant director for Life Sciences, OSTP, at (202) 456-6137.Draft ICH Guideline For Investigator's BrochureThe International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human Use(ICH) has produced a draft guideline for investigator brochures.Investigator Brochures are critical to helping clinicians understand andcomply with clinical research protocols.The draft guideline, crafted by the ICH's Efficacy Expert WorkingGroup, is available for a 60-day period of public comment. It will beincorporated into a larger ICH document on good clinical practices at alater date.The ICH is attempting to harmonize technical requirements for drugmanufacturers among the European Union, Japan, and the U.S. The sixsponsors of ICH are the European Commission on Medicinal Products,the European Federation of Pharmaceutical Industry Associations, theJapanese Ministry of Health and Welfare, the Japanese PharmaceuticalManufacturers Association, the FDA and the Pharmaceutical andResearch Manufacturers of America.Ultimately, the FDA intends to adopt the ICH Steering Committee'sfinal guidelines and recommendations.The draft "Guideline for the Investigator's Brochure" was printed inthe Aug. 9 Federal Register (pp. 40772-40787). For furtherinformation, contact Bette Barton at FDA's Center for Drug Evaluationand Research, (301) 594-1032.$5.8M In FDA Orphan Product Grants AvailableThe FDA's Orphan Products Development (OPD) grant program hasbudgeted $5.8 million in 1995 to help fund clinical trials of drugs,biologics, devices and medicinal foods for rare diseases. An orphandisease or condition is defined as one that affects fewer than 200,000people in the U.S.The total 1995 OPD grant budget is anticipated to be $12 million, but$6.2 million will fund ongoing grants from previous years. That leaves$5.8 million to be divided among competing grant applications.Of that $5.8 million, half ($2.9 million) is reserved to fund 20 grants(for Phase I, II or III trials) up to $100,000 per year each in direct costs,plus indirect costs for up to 3 years. Another $2.9 million is reserved tofund 10 grants (for Phase II and III trials only) up to $200,000 per yeareach in direct costs, plus indirect costs for up to 2 years.A notice in the Aug. 15 Federal Register noted that Public HealthService policy requires that clinical research grants should includeminorities and women in study populations so that research findingsare relevant to all persons at risk of the disease or condition understudy. For further information, contact Carol Wetmore or PatriciaRobuck at the FDA's Office of Orphan Products Development, (301)443-4903.PTC Document For Manufacture,Testing Of Monoclonal AntibodiesThe FDA announced that a draft points to consider (PTC) document,"Points to Consider in the Manufacture and Testing of MonoclonalAntibodies Products for Human Use," is available for review. The draftPTC is an update to a PTC document on the same topic published in1987 and contains general guidance from the FDA's Center forBiologics Evaluation and Research (CBER).The updated monoclonal antibody PTC draft specifies information tobe included in investigational new drug applications and productlicense applications. The document may be obtained by calling theCBER Fax Information System at (301) 594-1939 from a fax machinewith a touch tone phone attached or built in. n
-- Lisa Piercey Washington Editor
(c) 1997 American Health Consultants. All rights reserved.