Subject: Import Curbs Said To Stall Research On Abortion Pill 
Date: Published: 11/20/90 (78 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Import Curbs Said
    To Stall Research
    On Abortion Pill
    ----
    By Timothy Noah
    Staff Reporter of The Wall Street Journal

    WASHINGTON -- An import restriction against an abortion
 pill manufactured in France is impeding U. S. research into
 the drug's effectiveness in treating breast cancer, AIDS and
 other fatal diseases, two U. S. scientists charged.
    But Food and Drug Administration officials testified at a
 congressional hearing that the import alert, issued last
 year, was aimed only at individuals seeking to bring in the
 drug for personal use and didn't affect scientific research.
    The pill, RU-486, is marketed in France by Roussel-Uclaf
 as an alternative to surgical abortion.  The drug's approval
 is vigorously opposed by anti-abortion groups, which have
 threatened to boycott any company that seeks FDA approval to
 market the drug here.  Thus far, no company has said it will
 seek such approval.
    In recent years, the pill's role as an inhibitor of
 progesterone has led scientists to examine its value as a
 treatment for a variety of diseases.  To allow this research,
 the FDA has approved about 10 investigational new drug
 applications submitted by medical researchers.  But the FDA
 has received fewer research applications in recent months,
 and two scientists at the hearing charged that the FDA's
 import restriction has made medical research more difficult.
    "I'm absolutely thwarted," said Dr. Kathryn Horowitz, a
 professor of medicine at the University of Colorado in
 Denver.  Dr. Horowitz, who performs basic research on the role
 of sex hormones in breast cancer, said the FDA action has
 made it impossible for her to acquire RU-486.  She said that
 because her work involves lab rather than clinical research,
 she isn't eligible to file an investigational new drug
 application to the FDA.  
    Dr. William Regelson, a professor of medicine at the
 Medical College of Virginia, has sought to study RU-486's use
 as a treatment for AIDS.  He testified that such efforts were
 similarly "whiplashed" by the FDA action, which he suggested
 has made Roussel-Uclaf less willing to provide the drug for
 U. S. -based research projects.
    The FDA generally allows small quantities of drugs that it
 hasn't approved to be brought into the U. S. by individuals
 for personal use, provided the drugs meet certain criteria.
 Among these is that the drug must be used to treat a serious
 illness for which there is no commercially available
 alternative and that it must pose no unreasonable safety
 risks.  The FDA has banned the import of 58 drugs world-wide.
    Ronald G. Chesmore, FDA associate commissioner for
 regulatory affairs, argued at the hearing that RU-486 easily
 meets these criteria, saying the drug can cause excessive
 bleeding in women seeking to abort a fetus.
    But Rep. Ron Wyden (D., Ore.)  , chairman of the regulation
 subcommittee of the House Small Business Committee, argued
 that the import ban had little practical value because
 Roussel-Uclaf doesn't allow individuals to purchase the drug;
 women who want to use the drug to abort a fetus are permitted
 to receive it only at a licensed clinic.  Rep. Wyden charged
 that the FDA's concern was political, noting that the import
 restriction was issued soon after several conservative House
 members wrote to Frank Young, then-commissioner of the FDA,
 to complain about U. S. citizens' possible access to the drug.
    A spokesman for Hoechst-Roussel Pharmaceuticals Inc.,
 Somerville, N. J., of which Roussel-Uclaf is a minority
 stockholder, declined to comment about the drug.  He said,
 "We're not related or involved in that product whatsoever,"
 and declined to name any U. S. spokesperson for Roussel-Uclaf.

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