Subject: FDA Is Prepared To Allow Sales Of Female Condom 
Date: Published: 4/28/93 (68 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Health:
    FDA Is Prepared
    To Allow Sales
    Of Female Condom
    ----
    By Rose Gutfeld
    Staff Reporter of The Wall Street Journal

    WASHINGTON -- The Food and Drug Administration said it is
 prepared to give marketing approval -- with certain restrictions --
 to the first female condom, a contraceptive designed to help women
 guard against AIDS.  
    Wisconsin Pharmacal Co., which plans to market the condoms under
 the name Reality, said it hopes to begin selling the product by this
 fall.
    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.
    The agency said it has decided to approve the condom because it
 is the only product of its kind ready for marketing.
    "The female condom is not all we would wish for, but it is better
 than no protection at all," FDA Commissioner David Kessler said.  Dr. 
 Kessler stressed, however, that male latex condoms remain the best
 protection against sexually transmitted diseases and that couples
 should continue to use them.
    The FDA said that to gain approval for its female condom,
 Wisconsin Pharmacal must indicate on the product label that male
 latex condoms provide "highly effective protection" against sexually
 transmitted diseases such as acquired immune deficiency syndrome.
    The labels also must compare the pregnancy rate for female condom
 users, about 26% a year in U. S. trials, with rates for other female
 barrier contraceptives, which are lower.
    Jackson, Wis.-based Wisconsin Pharmacal said it plans to
 participate in additional effectiveness studies of the product and
 conduct focus group studies on the label.
    In announcing its intended approval, the FDA noted that it had
 reservations about the limited data available on the protection the
 condom offers against sexually transmitted diseases, the high
 pregnancy rate among users, the short duration of the clinical
 trials on the product, and the limited number of women involved in
 the trials.
    The product had been given an expedited FDA review because the
 agency said women needed a way to protect themselves without
 depending on their partners.
    Separately, the FDA said it is proposing to require manufacturers
 of inflatable penile implants to submit scientific data
 demonstrating that the products are safe and effective.
    The agency said that since 1984 it has received more than 6,500
 reports of problems with the devices, which can provide erection on
 demand and are used to treat impotence.
    The problems include infection, migration of the device into
 other parts of the body and mechanical malfunctions, the agency
 said, adding that the potential for long-term adverse effects isn't
 known.  Comments will be accepted for 60 days on the proposal, which
 is scheduled to appear in today's Federal Register.
    About 250,000 men in the U. S. have these implants, which are made
 of silicone rubber or polyurethane rubber.  About 28,000 are
 implanted annually.

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