[Public Papers of the Presidents of the United States: William J. Clinton (1993, Book I)]
[January 22, 1993]
[Page 11]
[From the U.S. Government Publishing Office www.gpo.gov]



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

[Filed with the Office of the Federal Register, 1:20 p.m., February 3, 
1993]