Subject: Congress Clears Legislation Altering Orphan Drug Act
Date: Published: 10/25/90 (40 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology:
    Congress Clears Legislation
    Altering Orphan Drug Act

    WASHINGTON -- Congress cleared legislation to limit the
 circumstances in which companies can obtain exclusive rights
 to market certain drugs for rare diseases.  President Bush is
 expected to sign the bill into law.
    The House passed the bill on a voice vote, accepting a
 Senate amendment to delay the effective date.  The bill
 revises the 1983 Orphan Drug Act.  But the amendment
 effectively exempts from many of the bill's requirements
 drugs for which companies submit applications before the
 bill's final enactment.
    Sens. Orrin Hatch (R., Utah), Christopher Dodd (D., Conn.)  
 and Frank Lautenberg (D., N.J.) pushed the amendment after
 lobbying by Johnson & Johnson of New Brunswick, N.J.;
 American Cyanamid Co. of Wayne, N.J.; and Glaxo
 Pharmaceuticals of Research Triangle Park, N.C., which is a
 unit of London-based Glaxo Holdings PLC.  All three companies
 have pending orphan drug applications that will benefit from
 the delay.
    Among other things, the bill would provide that a company
 can retain exclusive rights for an orphan drug only as long
 as the drug's patient population remains below 200,000.  This
 provision is likely to affect Lyphomed, which manufactures
 the drug pentamadine, an antipneumonia drug for AIDS
 patients.  The number of HIV-positive patients who may require
 pentamadine is believed to be approaching 200,000.  Lyphomed
 is a unit of Japan-based Fujisawa Pharmaceutical Co., whose
 U. S. headquarters are in Deerfield, Ill.

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