42 U.S.C. § 236 — Orphan Products Board

(a) Establishment; composition; chairman: The Orphan Products Board is created inside the Department of Health and Human Services, to work on developing drugs (including biologics) and devices (including diagnostic products) for rare diseases or conditions. Its members are the Assistant Secretary for Health, plus representatives the Secretary picks from the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and any other federal agency the Secretary decides is relevant. The Assistant Secretary for Health chairs the Board. (b) Function: The Board's job is to promote development of drugs and devices for rare diseases, and to coordinate the federal, other public, and private agencies working on them. (c) Duties with respect to drugs for rare diseases or conditions: For rare-disease drugs, the Board must: (1) evaluate the effect of the relevant part of the Federal Food, Drug, and Cosmetic Act on drug development, and how that law is being carried out; (2) evaluate NIH's activities developing these drugs; (3) make sure the FDA, NIH, and CDC coordinate so their efforts complement each other; (4) coordinate among all interested federal agencies, manufacturers, and groups representing patients; (5) with the drug sponsor's consent, inform physicians and the public about the availability of exempt or approved rare-disease drugs; (6) look for businesses to sponsor these drugs, investigators to help develop them, and businesses to help distribute them; and (7) recognize public and private efforts to develop drugs for rare diseases. (d) Consultation: The Board must consult with interested people about its activities, including giving them a chance to give oral views. (e) Annual report; contents: The Board must send Congress a yearly report that identifies drugs designated for a rare disease, describes the Board's activities, and gives the results of its evaluations. The Director of NIH must contribute a report on rare-disease research; the Secretary of the Treasury must contribute a report on the use of a specific tax credit; and the Secretary of Health and Human Services must contribute a report on a drug-development assistance program. Each annual report is due by June 1 for the preceding calendar year.