Answers
02/03/1995

<TITLE>RULES PROPOSED FOR SPERMICIDES</TITLE>
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T95-7                                            Susan Cruzan
Feb. 3, l995                                     301-443-3285

                 RULES PROPOSED FOR SPERMICIDES

     FDA today published a proposed rule that would ask
manufacturers of over-the-counter spermicide products to submit
data demonstrating that the final formulations of the products are
effective as contraceptives.  The agency has already concluded that
the active ingredients in marketed spermicides generally are safe,
but their effectiveness in final product formulations is highly
variable.  Therefore, the agency is proposing that manufacturers
submit new drug applications for all individual spermicide
products.
     The following can be used to answer questions.
     Spermicide contraceptives are available in foam, gel, cream,
film and suppository formulations.  They work by forming a physical
and chemical barrier to sperm in the vagina.  The active ingredient
in most products is nonoxynol-9; some products contain octoxynol-9. 
     There is evidence that some formulations of spermicide
products can lose effectiveness during use.  For this reason FDA
believes that clinical data are needed to ensure that over-the-
counter spermicide products remain effective as contraceptives
during actual use.        
     Vaginal contraceptives also are sometimes associated with
vaginal irritation, which may play a role in transmission of 
sexually transmitted diseases.  Therefore the proposal asks 
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                                     Page 2, T95-7, SPERMICIDES
manufacturers to collect information on the occurrence of vaginal
irritation during the clinical trials on their products, and to
present these data as part of the NDA.
     Although the proposal is not intended to cover claims for
prevention of sexually transmitted diseases (STDs) including HIV,
the agency strongly encourages manufacturers to evaluate products
for prevention of infectious diseases.  While none of these
products currently has an approved indication for prevention of
STDs, FDA is aware of literature reports and other data suggesting
they may play a role. Separate clinical trials need to be conducted
before such claims could be made for the products.  Manufacturers
have been asked to consult with the agency on the data
requirements.       
     Marketing status of over-the-counter spermicide products would
not be immediately affected by the proposed rule.  To assure
continued availability of affected products after a final rule is
published, FDA is encouraging manufacturers to contact the agency
as soon as possible so that clinical studies can be conducted and
applications approved as quickly as feasible.  
     Products that fail to meet the requirements of the final rule
would be considered unapproved new drugs and subject to regulatory
action.  
     Comments on the proposal may be sent within 120 days to
Dockets Management Branch (HFA-305), Food and Drug Administration, 
Rm. 1-23, 12420 Parklawn Drive, Rockville, Md. 20857.  
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