    [Weekly Compilation of Presidential Documents Volume 29, Number 3 (Monday, January 25, 1993)]
    [Page 89]
    [Online from the Government Publishing Office, www.gpo.gov]

    <R04>
    Memorandum on Importation of RU-486

     January 22, 1993

    Memorandum for the Secretary of Health and Human Services

    Subject: Importation of RU-486

        In Import Alert 66-47, the Food and Drug Administration (``FDA'')
    excluded the drug Mifepristine--commonly known as RU-486--from the list
    of drugs that individuals can import into the United States for their
    ``personal use,'' although the drugs have not yet been approved for
    distribution by the FDA. (See FDA Regulatory Procedures Manual, Chapter
    9-71.) Import Alert 66-47 effectively bans the importation into this
    Nation of a drug that is used in other nations as a nonsurgical means of
    abortion.
        I am informed that in excluding RU-486 from the personal use
    importation exemption, the FDA appears to have based its decision on
    factors other than an assessment of the possible health and safety risks
    of the drug. Accordingly, I hereby direct that you promptly instruct the
    FDA to determine whether there is sufficient evidence to warrant
    exclusion of RU-486 from the list of drugs that qualify for the personal
    use importation exemption. Furthermore, if the FDA concludes that RU-486
    meets the criteria for the personal use importation exemption, I direct
    that you immediately take steps to rescind Import Alert 66-47.
        In addition, I direct that you promptly assess initiatives by which
    the Department of Health and Human Services can promote the testing,
    licensing, and manufacturing in the United States of RU-486 or other
    antiprogestins.
        You are hereby authorized and directed to publish this memorandum in
    the Federal Register.
                                                William J. Clinton