Docket Management
Docket: 80N-0280 - Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling
Comment Number: EC -136

Accepted - Volume 14

Comment Record
Commentor Mr. Alexander McLaren Date/Time 2003-04-14 08:02:12
Organization Medicines & Healthcare products Regulatory Agency
Category Other

Comments for FDA General
1. General Comments To Whom It May Concern We are the medicines & devices regulatory authority for the UK - please could you comment on the following points... 1) You refer to OTC vaginal contracecptives, does this include CONDOMS? 2) You have only commented on N-9 used for vaginal use - it is apparent that N-9 is regarded as an anti-HIV / STI chemical by many people. It may therefore be used rectally by some people, whether it is recommended or not or whether it is a contraceptinve spermicide - Why have you not included guidance about rectal use? 3) You have qouted more than once a day as frequent use. However the data supporting this appears weak - will you apply this? Women are generally recommended to apply more spermicide to their diaphragms if they engage in sexual intercourse 2 or more hours after the last. Your advice appears to restrict the amount of times a woman may engage in intercourse per day. Once is surely too restrictive? We are shortly about to issue our own advice to the UK. We would appreciate your comments. Thank you Alexander McLaren Medical Device Specialist / Compliance Inspector MHRA

EC -136