Answers
01/12/1995

<TITLE>TODAY SPONGE</TITLE>
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T95-1                                       Donald C. McLearn
Jan. 12, 1995                                (301) 827-6242

                          Talk Paper

                          TODAY SPONGE

     FDA has been receiving inquiries regarding the decision of
Whitehall-Robins Healthcare to stop manufacturing Today Sponge, a
contraceptive for women.  The following can be used to answer
questions:
      Today Sponge has been in short supply since the firm
stopped production after FDA's inspection in March 1994 of the
only facility manufacturing the contraceptive.
     The comprehensive inspection of the firm's plant in
Hammonton, N.J., disclosed bacterial contamination of the water
used to make the Today Sponge as well as other products
manufactured in the facility, including nasal sprays, ointments
and suppositories.
     FDA investigators also established that the firm had
neglected to validate its microbiological test methods, thereby
raising questions about their reliability.  Still other problems
were found in the firm's equipment sanitization.
     Recently, after weighing the cost of modifications that
would be necessary to bring the Hammonton plant up to acceptable 
                             -MORE-

                                   Page 2, T95-1, TODAY SPONGE
manufacturing standards, as well as the likely loss of Today
Sponge's market share by the time the upgrading would be
completed, the firm announced its decision to stop making the
contraceptive.
     The agency did not object to continued production of Today
Sponge under appropriate manufacturing and hygienic conditions.
Long-standing public health standards, however, do not allow the
marketing of contaminated products that present a potential risk
of disease transmission.
     Consumers should be aware that Today Sponge is only one of
many OTC contraceptives for women that are on the market,
including a female condom and spermicides.  Available
prescription contraceptives for women include IUD, injection,
implant, diphragm and cervical cap with spermicide, and various
birth control pills.
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