Subject: Panel Urges FDA To Approve Sale Of Female Condom 
Date: Published: 2/3/92 (59 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Medicine:
    Panel Urges FDA
    To Approve Sale
    Of Female Condom
    ----
    By Bruce Ingersoll
    Staff Reporter of The Wall Street Journal

    ROCKVILLE, Md.  -- A Food and Drug Administration advisory
 panel recommended that the agency approve the first female
 condom for marketing if it passes certain safety and
 effectiveness tests.
    Wisconsin Pharmacal Co. officials, who plan to sell the
 new contraceptive device under the Reality brand name, said
 they expect to produce the required test results by the
 summer, and expect to have the product on the market by the
 fall.
    "We don't see this as a significant delay," Mary Ann
 Leeper, senior vice president for development, said after the
 panel's unanimous vote Friday for conditional approval.  "We
 see this as a happy outcome."
    Advisory panel recommendations, while not binding, are
 usually heeded by the agency.
    The female condom, invented in Denmark, is essentially a
 seven-inch-long, lubricated pouch made of polyurethane, with
 flexible rings at each end.  The inner ring fits behind the
 pubic bone and the outer ring fits outside the body.
    Clinical trials, according to company officials, show that
 it is as effective as contraceptive sponges and diaphragms in
 preventing pregnancy, and that it has the added advantage of
 being more effective than male condoms in preventing AIDS and
 other sexually transmitted diseases.
    The FDA's Obstetrics and Gynecology Device Panel,
 nonetheless, decided that additional tests were in order.  It
 called for a six-month clinical trial involving 200 women to
 further evaluate the device's safety and effectiveness.  At
 the same time, used condoms are to be inspected for tears and
 other defects.
    The panel said that FDA approval should be contingent on
 the company being able to match or better the condom's
 contraception rate in clinical trials.  The company reported
 15.1 pregnancies per 100 women -- a contraception rate of
 nearly 85% -- after six months.  Contraceptive sponges are 80%
 to 87% effective, while diaphragms with spermicide are 80% to
 98% effective, according to the FDA.  
    Wisconsin Pharmacal, based in Jackson, Wis., owns the
 North American rights to manufacture and market the female
 condom.  It will likely be priced at $2 or $2.25, about three
 times the typical price for male condoms.  Chartex
 International PLC of London holds the rights to sell the
 product in Europe and the rest of the world.

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