From: Toni Belfield [tonib@fpa.org.uk]
Sent: Wednesday, April 16, 2003 4:57 AM
To: fdadockets@oc.fda.gov
Subject: FDA Proposed Labelling Changes for OTC Vaginal

FDA Proposed Labelling Changes for the Spermicide – Nonoxynol 9



Comments from UK fpa (Family Planning Association), 

Toni Belfield – Director of Information

14th April 2003



Document Reference -  Docket Number  – 80N-0280



fpa (Family Planning Association) in the UK welcomes moves to address the new global recommendations from the World Health Organisation (WHO) about the use of the spermicide, Nonoxynol 9.

fpa supports the 2002 recommendations from WHO that state;



Ø       Women at high risk of infection should not use Nonoxynol 9 for contraception.  It remains a contraceptive option for women at low risk, but is not as effective as other contraceptive methods.

Ø       Nonoxynol 9 should not be used rectally.

Ø       Nonoxynol 9 lubricated condoms should no longer be promoted; however, it is better to use a Nonoxynol 9 lubricated condom than no condom.



fpa has concerns about the proposed wording used in the draft FDA consultation document.  It has concerns about the wording used both for the labelling changes for all marketed OTC vaginal contraceptives containing Nonoxynol 9 and for the proposed information to be included in the patient package insert.  Our concerns relate directly to the following wording;



Ø       Proposed labelling direction - ‘Ask a doctor before use if you have a new sex partner, multiple sex partners, or unprotected sex. Frequent use (more than once a day) of this product can increase vaginal irritation, which may increase the risk of becoming infected with the AIDS virus (HIV) or other STDs from infected partners.’

Ø       Proposed information for patient package insert – ‘Studies have raised safety concerns that frequent use (more than once a day) of products containing Nonoxynol 9 can increase vaginal irritation, which may increase the risk of getting the AIDS virus (HIV) or other STDs from infected partners.’



fpa is particularly concerned about how the FDA has interpreted and defined ‘frequent use (more than once a day) of products containing Nonoxynol 9.’  Our concerns lay with how this advice is used and interpreted for women who use spermicide WITH female barrier methods (diaphragms and caps) as against use of spermicide alone.  Current advice for the most effective use of diaphragms and caps recommends the need to use spermicide with diaphragms and caps to improve contraceptive effectiveness.  In addition, advice also indicates the need to insert more spermicide (without removal of the diaphragm or cap) if repeat intercourse occurs, or if more than three hours elapse between insertion of the diaphragm or cap and the commencement of sexual intercourse.  The proposed labelling and product information changes being suggested by FDA would effectively make it impossible to provide clear advice for women at low risk of acquiring infection, but who use the diaphragm or cap for their ongoing contraception.  Sadly, there is little data about the efficacy of diaphragms or caps without additional spermicide.  Small studies have been carried out, but results are not statistically robust enough to recommend discontinuation of spermicide with diaphragm or cap use.  It is interesting to note, however, that introduction of all the new silicone caps (FemCap, Oves Cap and Lea’s Shield) all recommend use of additional spermicide to improve contraceptive effectiveness. fpa is aware that larger studies are now being carried out in the US looking at diaphragm protection (used alone) against, Chlamydia, Gonorrhoea and HIV.  



fpa does not know what data the FDA used to define frequent use as being ‘more than once a day’. The WHO data does show that frequency of epithelial disruption seems to depend on the intensity of use of spermicide – from 18 percent of women using the product every other day to 53 percent using it four times a day.  As such, WHO concluded that ‘women who have multiple acts of intercourse should be advised to choose another method of contraception.’  However, this data addresses spermicide use alone, not concurrent use with female barrier methods, such as diaphragms or caps. 



As such the issues fpa UK raise are;



Ø       can the FDA recommendation use data addressing the use of Nonoxynol 9 alone and extrapolate this to women who wish to use spermicides with barrier methods for contraception?

Ø       what truly constitutes  ‘frequent’ use and again how does this relate to use with barrier methods?

Ø       how does ‘frequency of use’ of Nonoxynol 9 relate to vaginal irritation and how does this in turn relate to the increase of infection with HIV or other STIs (which again will be different in women using spermicides with female barrier methods)?



In summary, the proposed wording raises a number of questions which has potential for confusion when giving advice to women at low risk of acquiring an STI who wish to use female barrier methods, that currently demand the use of additional spermicide to improve contraceptive efficacy.  



Should the proposed wording remain and this guidance become a general recommendation, it is likely to deter promotion, uptake and use of female barrier methods that require additional spermicide for the future.  fpa hopes these points will be considered by FDA.



End.