Document 0464
 DOCN  M9590464
 TI    Rare diseases, drug development, and AIDS: the impact of the Orphan Drug
       Act.
 DT    9509
 AU    Arno PS; Bonuck K; Davis M; Department of Epidemiology and Social
       Medicine, Montefiore; Medical Center/Albert Einstein College of
       Medicine, Bronx, NY; 10467-2490, USA.
 SO    Milbank Q. 1995;73(2):231-52. Unique Identifier : AIDSLINE MED/95295637
 AB    The Orphan Drug Act provides public subsidies and incentives to spur the
       development of drugs for rare diseases--drugs that the private sector
       might otherwise consider unprofitable to produce. Although the act has
       achieved numerous successes, the high prices and extraordinary sales
       generated by some orphan drugs lead to a pivotal policy question: how
       can the act be used to meet the legislative goal of stimulating drug
       development for small patient populations without resulting in prices
       that make drugs inaccessible? This question is explored using the
       example of AIDS drugs, many of which received subsidies under the act,
       to illustrate central points. The history of the act, its weaknesses,
       and strategies for reform are described as well.
 DE    Acquired Immunodeficiency Syndrome/*DRUG THERAPY  Antiviral
       Agents/CHEMICAL SYNTHESIS  AIDS-Related Opportunistic Infections/DRUG
       THERAPY  Drug Costs  Drug Industry  Financing, Government  Human  Orphan
       Drug Production/ECONOMICS/*LEGISLATION & JURISPRUD  Patents/LEGISLATION
       & JURISPRUD  Support, Non-U.S. Gov't  United States  United States Food
       and Drug Administration  JOURNAL ARTICLE  REVIEW  REVIEW, TUTORIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).