Orphan Drug Amendments of 1985

(Senate agreed to House amendment with an amendment) Orphan Drug Amendments of 1985 - Amends the Federal Food, Drug, and Cosmetic Act to repeal the requirement that exclusive marketing rights may only be granted to an orphan drug (a drug used in the treatment of a rare disease or condition) if the drug is not patentable. Authorizes the sponsor of an antibiotic drug for a rare disease to request the Secretary of Health and Human Services to provide written recommendations for the investigations which must be conducted before such drug will be certified for use. Establishes a National Commission on Orphan Diseases (Commission). Requires the Commission to assess the activities of the National Institutes of Health, the Alcohol, Drug Abuse, and Mental Health Administration, the Food and Drug Administration, other public agencies, and private entities in connection with: (1) basic research relating to rare diseases; (2) the use in research on rare diseases of knowledge developed in other research; (3) applied and clinical research relating to the prevention, diagnosis, and treatment of rare diseases; and (4) the dissemination of knowledge developed in research relating to rare diseases. Requires the Commission to submit a report, by the end of FY 1987, to the Secretary and to the Congress containing the Commission's findings, conclusions, and recommendations. Makes funds available to the Commission. Terminates the Commission 90 days after the date of such report. Amends the Orphan Drug Act to allow Federal grants and contracts for animal and human clinical testing of orphan drugs. Authorizes appropriations for such grants and contracts for FY 1986 through 1988. Amends the Developmental Disabilities Assistance and Bill of Rights Act to permit a State with an optional services waiver under the program of providing priority services to the disabled to continue such waiver on a limited basis through FY 1987. Amends the Public Health Service Act to require the Secretary to carry out projects to encourage the regionalization of educational responsibilities of health professions schools through qualified area health education centers which are no longer eligible to receive assistance.

(Measure passed House, amended, in lieu of H.R. 2290) Orphan Drug Amendments of 1985 - Amends the Federal Food, Drug, and Cosmetic Act to repeal the requirement that exclusive marketing rights may only be granted to an orphan drug (a drug used in the treatment of a rare disease or condition) if the drug is not patentable. Authorizes the sponsor of an antibiotic drug for a rare disease to request the Secretary of Health and Human Services to provide written recommendations for the investigations which must be conducted before such drug will be certified for use. Establishes a National Commission on Orphan Diseases (Commission). Requires the Commission to assess the activities of the National Institutes of Health, the Alcohol, Drug Abuse, and Mental Health Administration, the Food and Drug Administration, other public agencies, and private entities in connection with: (1) basic research relating to rare diseases; (2) the use in research on rare diseases of knowledge developed in other research; (3) applied and clinical research relating to the prevention, diagnosis, and treatment of rare diseases; and (4) the dissemination of knowledge developed in research relating to rare diseases. Requires the Commission to submit a report by the end of FY 1987 to the Secretary and to the Congress containing the Commission's findings, conclusions, and recommendations. Makes funds available to the Commission. Terminates the Commission 90 days after the date of such report. Amends the Orphan Drug Act to allow Federal grants and contracts for animal and human clinical testing of orphan drugs. Authorizes appropriations for such grants and contracts for FY 1986 through 1988. Amends the Developmental Disabilities Assistance and Bill of Rights Act to permit a State with an optional services waiver under the program of providing priority services to the disabled to continue such waiver on a limited basis.

Orphan Drug Amendments of 1985 - Amends the Federal Food, Drug, and Cosmetic Act to repeal the requirement that exclusive marketing rights may only be granted to an orphan drug (a drug used in the treatment of a rare disease or condition) if the drug is not patentable. Establishes a National Commission on Orphan Diseases. Requires the Commission to assess the activities of the National Institutes of Health, the Alcohol, Drug Abuse, and Mental Health Administration, the Food and Drug Administration, other public agencies, and private entities in connection with: (1) basic research relating to rare diseases; (2) the use in research on rare diseases of knowledge developed in other research; (3) applied and clinical research relating to the prevention, diagnosis, and treatment of rare diseases; and (4) the dissemination of knowledge developed in research relating to rare diseases. Requires the Commission to submit a report by September 30, 1987, to the Secretary of Health and Human Services and to each House of the Congress containing the Commission's findings, conclusions, and recommendations. Makes funds available to the Commission. Terminates the Commission 90 days after the date of such report. Amends the Orphan Drug Act to allow Federal grants and contracts for preclinical and human clinical testing of orphan drugs. Authorizes appropriations for such grants and contracts for FY 1986 through 1988. Makes technical corrections to the Departments of Labor, Health and Human Services, Education and Related Appropriation Act, 1985 in order to allow the expenditure of funds for personnel training under the Education of the Handicapped Act until September 30, 1985.