Docket Management
Docket: 80N-0280 - Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling
Comment Number: EC -144

Accepted - Volume 14

Comment Record
Commentor Ms. Heather Boonstra Date/Time 2003-04-16 17:23:09
Organization The Alan Guttmacher Institute
Category Other

Comments for FDA General
Questions
1. General Comments April 16, 2003 Re: [Docket No. 80N-0280] To Whom It May Concern: On behalf of The Alan Guttmacher Institute (AGI), a not-for-profit corporation that conducts research, policy analysis and public education on matters related to sexual and reproductive health, I appreciate the opportunity to submit comments on the planned warning label for over-the-counter (OTC) vaginal products containing nonoxynol-9 (N-9), which the Food and Drug Administration (FDA) proposed on January 16, 2003 in the Federal Register. The Institute shares the FDA’s concern that consumers may be inadvertently putting themselves at risk because they believe that vaginal contraceptives containing N-9 provide protection against transmission of HIV and other sexually transmitted diseases (STDs). We support the FDA in its effort to provide users with a clear and scientifically-based message that N-9 is not protective against HIV and other STDs and that frequent use (more than once a day) may increase the risk of infection. Appropriately, the proposed warning informs consumers of this risk so that they can make responsible and good health care decisions, while preserving access to an important option for non-hormonal contraception. Moreover, we support the FDA’s decision to include messages about the importance of correct condom use for the prevention of HIV/AIDS and other STDs. Indeed, a summary report issued in July 2001 by a panel convened by the National Institutes of Health concludes that consistent and correct condom use has been demonstrated to prevent transmission of HIV between women and men and gonorrhea transmission from women to men, and that there that there is “a strong probability of condom effectiveness” against other STDs. In the words of the report, “Beyond mutual lifelong monogamy among uninfected couples, condom use is the only method for reducing the risk of HIV infection and STDs available to sexually active individuals.” The proposed warning label, nevertheless, falls short by failing to address rectal use of vaginal contraceptives containing N-9. Even recognizing that these products are approved for vaginal use only, as a matter of public health the FDA ought not ignore that contraceptives containing N-9 are being used during anal intercourse for lubrication and (mistakenly) for protection against disease. In many ways, the safety concerns for rectal use far outweigh that for vaginal use. Studies indicate that N-9 used vaginally is safe for infrequent use (less than 1.5 times per day), affecting the majority of women. By comparison, N-9 used rectally is dangerous at any level. Research indicates that products that contain even small amounts of N-9 when used rectally cause massive, short-term sloughing of the rectal epithelium, facilitating the transmission of disease. We urge you to not let these critical safety concerns go unaddressed. Given the high likelihood of harm posed by the misuse of OTC contraceptive products rectally, we recommend that the label include an explicit warning to consumers seeking to protect themselves against HIV and other STDs against rectal use of these products. Sincerely yours, Jacqueline E. Darroch, Ph.D. Senior Vice President and Vice President for Science The Alan Guttmacher Institute




EC -144