Orphan Drug Amendments of 1985

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…

Congressional Research Service · 1985-05-15