Docket Management
Docket: 80N-0280 - Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling
Comment Number: EC -101

Accepted - Volume 14

Comment Record
Commentor Dr. Janet Arrowsmith-Lowe Date/Time 2003-02-15 17:00:40
Organization Arrowsmith-Lowe Consulting, Inc
Category Health Professional

Comments for FDA General
1. General Comments It would be helpful to have simple warnings in English and Spanish, on the packaging as well as a package insert with toll-free numbers and/or internet websites so that additional information may be obtained by persons of organizations desiring additional data or clarification. In addition, the Agency should consider requesting that manufacturers provide patient package information in English, Spanish, and other languages as appropriare for distribution through pharmacies, clinics and physician offices as well as Dear Healthcare provider letters to help reinforce the new labeled warnings. The Centers for Disease Control should rapidly integrate the new warning information into commmunity programs and literature directed towards at-risk populations. I would also recommend that the final printed warning be considered for use in labeling N-9 containing or treated condoms. The studies upon which these labeling changes are based indicate, once again, that more research must be conducted to help develop safe, woman-controlled contraception; contraception which will, at least, be risk-neutral in its activity affecting sexually transmitted diseases, including HIV. I am hopeful that the PHS can offer funding or other support for organizations and manufacturers pursuing safer alternatives to N-9. Thank you for the opportunity to comment on the need for additional warnings for N-9 containing contraceptive products. Sincerely, Janet Arrowsmith-Lowe, MD Arowsmith-Lowe Consulting, Inc. --- Outgoing mail is certified Virus Free. Checked by AVG anti-virus system ( Version: 6.0.427 / Virus Database: 240 - Release Date: 12/07/2002

EC -101