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10 Am. J.L. & Med. 491 (1984-1985)
Orphan Drugs: The Question of Products Liability

handle is hein.journals/amlmed10 and id is 501 raw text is: Orphan Drugs: The Question of Products Lability ABSTRACT Orphan drugs, essential for the treatment of persons with rare diseases, generally are unprofitable for manufacturers to develop and market. While congressional and administrative efforts to promote the develop- ment of orphan drugs have met with modest success, application of products liability doctrine to orphan drug sponsors could subvert those efforts. This Note describes the provisions of the Orphan Drug Act and analyzes products liability law with respect to orphan drug litigation. It argues that the goals of tort law support the imposition of liability for design defect, failure to warn and negligence in testing. Finally, the Note acknowledges that liability costs create disincentives for orphan drug development and suggests mechanisms for reducing manufacturers' lia- bility concerns. I. INTRODUCTION Orphan drugs are medically important but unprofitable' drugs used for the treatment of rare diseases and conditions.2 As compared to drugs for common diseases, they command relatively small markets. Typically, large revenues generated by ordinary drug sales allow manufacturers to recoup the costs incurred in meeting Food and Drug Administration (FDA) testing requirements.3 The diminished potential for profit from the sale of I C. ASBURY, ORPHAN DRUGS: MEDICAL VS. MARKET VALUE (1985). Asbury recognizes several categories of orphan drugs, including: drugs tor rare diseases; drugs for chronic diseases; drugs for single administration (vaccines and diagnostic aids); drugs for women of childbearing age and for children; drugs that are not patentable; drugs for treating drug abuse; and drugs needed in developing nations. Id. at 4. Although similarities exist among these categories in terms of liability risk, market factors and testing limitations, this Note addresses only drugs for rare diseases and conditions. 2 Rare diseases include Huntington's disease, myoclonus, ALS (Lou Gehrig's disease), Tourette syndrome and muscular dystrophy. Orphan Drug Act § l(b), 21 U.S.C. § 360aa (1982). ' In 1984, research and development expenditures for the ten largest U.S. pharmaceuti- cal companies ranged from 3.8 to 11.5 percent of revenues. N.Y. Times, Feb. 24, 1985, § 3 at

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