NEWS
04/26/1993

<TITLE>Approval -- with restrictive labeling -- the Reality Female Condom</TITLE>
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          STATEMENT BY THE FOOD AND DRUG ADMINISTRATION




     The Food and Drug Administration today announced it is
prepared to approve -- with restrictive labeling -- the Reality
Female Condom, the first barrier contraceptive for women that also
offers limited protection against sexually transmitted diseases
(STDs).  The label will be required to emphasize that for "highly
effective protection" against STDs, including AIDS, it is important
to use latex condoms for men. 
     The female condom consists of a lubricated polyurethane sheath
with a flexible polyurethane ring on each end.  One ring is
inserted into the vagina much like a diaphragm; the other remains
outside partially covering the labia.
     In addition to the required endorsement of the safety offered
by latex condoms for men, the approval for the product will be
granted with these conditions:
     * The label must compare the pregnancy rate for female condom
users -- approximately 26 percent per year -- to rates for other
women's barrier contraceptives, which are lower.
     * The manufacturer must take part in additional effectiveness
studies for the product.
     "The female condom is not all we would wish for, but it is
better than no protection at all," FDA Commissioner David A.
Kessler, M.D., said.  "I have to stress that the male latex condom
remains the best shield against AIDS and other sexually transmitted
diseases. Couples should go on using the male latex condom."  
     FDA's decision to approve the female condom was based on a
review of clinical data submitted by the manufacturer and the
unanimous recommendation of the Obstetrics and Gynecology Devices
Advisory Panel at its meeting on Dec. 10, 1992.
     The agency gave the product an expedited review because it saw
an urgent need for a means whereby women can protect themselves
without depending on the cooperation of their partners. FDA had
reservations about the limited data available on protection the
female condom offered against STDs, as well as about the high
pregnancy rate among users, the small number of women in the
clinical studies and the short duration of the studies, which
lasted less than a year. Eventually, the agency decided to approve
the female condom as the only product of its kind ready for
marketing.  
     The manufacturer -- Wisconsin Pharmacal of Jackson, Wisc. --
studied 200 women who used the device for six months.  In the
study, the six-month pregnancy rate among U.S. women was
approximately 12.5 percent--or an estimated 26 percent per year. 
This high rate is believed to have been the result of improper use
of the device.  It compares to an expected rate of 85 percent among
women not using any contraceptive method.  Women who use the device
correctly each and every time they have intercourse can expect a
much lower pregnancy rate.
       
     Details of the required studies on the product's effectiveness
are being worked out.    
     FDA is one of the eight Public Health Service agencies within
HHS.
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