| Comment Record|
Dr. Vanessa Cullins ||
2003-04-16 12:09:14 |
Planned Parenthood Federation of America |
| Comments for FDA General |
1. General Comments
Planned Parenthood Federation of America, Inc.
1780 Massachusetts Avenue, NW
Washington, DC 20036
April 16, 2003
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Dear Sir or Madam:
Planned Parenthood Federation of America (“PPFA”), the nation’s oldest and most trusted voluntary reproductive health care organization, is pleased to respond to your request for comments on proposed new labeling warning statements for all over-the-counter (OTC) vaginal contraceptive drug products containing nonoxynol 9 (N-9) [21 CFR part 201]. It is the policy of PPFA to assure that all individuals have the freedom to make reproductive decisions. In order to enable the individual to make and implement a responsible decision, there should be access to information and services related to sexuality, reproduction, methods of contraception, fertility control, and parenthood.
We applaud the Food and Drug Administration (FDA) for their decision to provide clear, accurate, and scientifically supported labeling warnings on OTC vaginal contraceptive drugs containing N-9. Overall, we are pleased with the language proposed by FDA, and offer the following comments as suggestions for strengthening the proposed labeling and better protecting the public’s health.
“Sexually transmitted diseases (STDs) alert: This product does not protect against the AIDS virus (HIV) or other sexually transmitted diseases (STDs).”
Newly available scientific data supports this warning. Given the persistent public misconception that N-9 actually protects against STDs and HIV, we feel that this language should appear on both the product carton/exterior package and package insert. It is unclear from the Federal Notice where, precisely, this warning will appear.
“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. Ask a doctor or other health professional for your best birth control method.”
Although the subject of the proposed labeling warning statements is vaginal contraceptive products containing N-9 that are available over-the-counter, PPFA believes that all women and men can benefit from discussions with their health care providers. Such discussions can help patients better ascertain their risk status and make informed, appropriate decisions regarding contraception and risk reduction. We would suggest, however, that the language included in bold face be rewritten as follows:
“Ask your doctor or other health care provider if you have ....” Many patients see providers other than physicians, as you acknowledge later in the above paragraph.
“Stop use and ask a doctor if you or your partner get burning, itching, a rash, or other irritation of the vagina or penis.”
See comment above regarding “other health care provider.”
“For vaginal use only.”
PPFA recommends that this language be placed on both the product carton/exterior package and package insert. It is unclear from the Federal Notice where, precisely, this warning will appear. We further recommend that this language be strengthened to include a proactive warning against rectal use.
Although the products targeted by the proposed labeling warning statements have been approved only for vaginal use, health care providers and other advocates are well aware of their “off-label” use. In particular, many N-9 containing spermicides (and lubricants) are used during anal intercourse. Because of the preponderance of evidence indicating the substantial risk of epithelial sloughing when N-9 is used rectally, we feel that the FDA’s proposed warning labeling should be expanded. The above statement could and should be strengthened by the addition of language cautioning against any rectal use of N-9 containing products. Despite attempts among health care providers and advocates to dispel the popular myth that N-9 provides protection against STDs and HIV, this erroneous “word on the street” continues to persist. Given the overwhelming data that suggests that rectal use of products containing even small amounts of N-9 can cause massive, short-term sloughing of the rectal epithelium in humans, we believe that it is incumbent upon the FDA to provide this warning.
Last summer, after reviewing available scientific evidence, PPFA ceased production of Planned Parenthood-brand condoms containing N-9. This decision was based upon evidence indicating that not only is N-9 ineffective against STDs, but in circumstances of either single acts of anal intercourse or multiple acts of vaginal intercourse in one day, N-9 can increase susceptibility to HIV. Simultaneous to this decision, we reiterated our clarion call that correct and consistent us of condoms remains the most effective tool against the transmission of STDs and HIV.
Correct use of a latex condom with every sexual act will help reduce the risk of getting the AIDS virus (HIV) and other STDs.”
PPFA applauds FDA for advocating strongly the use of condoms. Correct and consistent use of condoms is the best-known way to protect against STDs, HIV, and unintended pregnancy. This statement is supported by years of scientific research that have yielded consistently affirming results.
Despite recent data indicating the potential harmful effects of N-9 when used rectally or frequently in the vagina, PPFA believes that the decision to use OTC vaginal contraceptive products containing N-9 must be made by women. We believe firmly that when women are provided with complete, accurate, and easy-to-understand information they will make informed and appropriate choices. For those women at low risk for STDs and HIV, these products remain an important contraceptive option. As such, we support wholeheartedly their continued availability. It is the responsibility of FDA to provide the information necessary to make such a decision, and PPFA commends FDA for proposing labeling warning statements that achieve this objective.
Vanessa Cullins, MD, MPH, MBA
Vice President, Medical Affairs