May 21, 2014
Jeffrey Shuren, M.D., J.D.
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Re: Female condom label and information on FDA website
Dear Dr. Shuren,
The 77 undersigned organizations represent a diverse and wide-ranging group of advocates from the sexual and reproductive health, reproductive justice, HIV/AIDS, and LGBTQ communities. We are writing to urge the FDA to update the label of the FC2 female condom to reflect the current state of the evidence regarding the effectiveness and safety of female condoms and to revise the “For Women Consumers: Birth Control” webpage to ensure women are provided with accurate information about the benefits and side effects of female condoms. We would also like to request a meeting with the Center for Devices & Radiologic Health and the Office of Women’s Health to discuss our concerns about the currently available information and our suggestions for appropriate updates.
Millions of women and men have used female condoms since they were first approved by FDA in 1993. They have been distributed and sold mainly in developing countries and sales have been steadily increasing in the United States. The FC2 is distributed in more than 100 countries worldwide. Clinical data show that female condoms have a good safety record and are effective and acceptable to women and men in a variety of countries. It is essential that the FDA ensure women and men in the U.S. have access to comprehensive and accurate information about the sexual and reproductive health technologies available to them.
Update the FC2 label
The current label for the FC2 label is not consistent with the latest research findings on female condoms and puts the U.S. out of step with the broader global health consensus on female condoms. We strongly urge the agency to revise the FC2 label by removing the first two bullets from the “Important Information” box and replacing them with accurate information about the female condom.
The first two bullets in the “important information” box send women and men the message that female condoms are inferior to male condoms and should only be used if male condom use is not possible. These statements do not accurately characterize the safety, efficacy, and benefits of the female condom and should be removed. A number of studies demonstrate that the protection offered by female condoms is comparable to that of male latex condoms at reducing unintended pregnancy and STIs. -10 Further data indicate that female condoms enable some women to initiate safer sex, thus taking greater control of their health.12-14 Such ability is of critical importance to the health of receptive partners, particularly in contexts where male condom use is not possible. With female condoms, receptive partners are not forced to rely on their partner for their own protection. The label for the female condom should offer consumers information about the product contained in the package instead of referencing other products. We urge replacing the first two bullet points with the following language:
- Female condoms reduce a person’s risk of HIV, STIs, and unintended pregnancy when used consistently and correctly. Use an FC2 to protect yourself and your partner.
- Never use a female condom and a male condom at the same time.
Update the website information
First, we greatly appreciate that the Office of Women’s Health made the updates we suggested to the female condom information on the agency’s “For Consumers/For Women” webpage15, which it is responsible for maintaining. The additional revisions we suggest here are to the “Birth Control: Barrier Methods” section of that OWH webpage. These revisions would ensure that women and men seeking information from the FDA about female condoms receive complete and accurate information.
In the “What is it?” section, the FDA website currently states that the female condom “is not made with natural rubber latex.” While this statement is accurate, it is not typical for the FDA to only describe characteristics that a medical device does not have. We recommend that the agency revise this bullet to provide complete information about FC2 materials. This revision will acknowledge that the FC2 is non-latex, thus benefiting individuals with latex allergies. We urge the use of the following bullet:
- A thin, flexible, lubricated pouch that is put into the vagina. It consists of a nitrile (non-latex) sheath and outer ring, and a polyurethane inner ring.
In the “How do I get it?” section, we recommend the agency include more information about sources of female condoms. This would provide women with additional options for places to get female condoms, particularly no or low-cost options, making them more accessible to low-income women. We urge the agency to include a bullet stating:
- You can receive it from some health departments and community-based organizations.
In the “Some Risks” section, the website states that irritation and allergic reactions are risks of the female condom. However, neither irritation nor allergic reaction are listed as side effects or risks on the FC2 label. In fact, the “Family Planning: Global Handbook for Providers,” which was written by the U.S. Agency for International Development, World Health Organization and Johns Hopkins University, states that there are no side effects and no known health risks associated with using female condoms16. We strongly urge the FDA to revise this section to ensure that the agency is providing timely and accurate information. To be consistent with current research and FC2 labeling, which includes side effects experienced in the clinical trials, we recommend that the FDA immediately remove the two bullets that provide incorrect information and replace them with the following statement:
- The vast majority of women who use female condoms experience no side effects. In research studies, rare side effects included discomfort during insertion or sex; pain after insertion, before sex; and burning sensation, rash or itching.
In the “Does it protect me from sexually transmitted infections (STIs)?” section, the website states that “natural rubber latex condoms for men are highly effective at preventing sexually transmitted infections, including HIV/AIDS, if used correctly” and “if you are not going to use a male condom, you can use the female condom to help protect yourself and your partner.” As noted earlier in the letter, this does not reflect the current state of knowledge regarding the safety and efficacy of female condoms. We urge the FDA remove the second bullet from that section and revise the first bullet to state:
- Yes. Except for abstinence, male and female condoms are the best protection against HIV/AIDS and other STIs.
We urge the FDA to update information about the female condom in accordance with our recommendations. We also ask the agency to ensure that information about the FC2 is consistent across various sources, such as the label, patient package insert, leaflet, and FDA website.
We would like to request a meeting with you and the Director of the Office of Women’s Health to discuss the concerns and suggestions outlined here. Please contact Jessica Terlikowski of the National Female Condom Coalition at firstname.lastname@example.org or (312) 334-0931 to schedule a meeting.
AIDS Community Research Initiative of America
AIDS Foundation Houston, Inc.
AIDS Foundation of Chicago
American Medical Student Association
American Medical Women’s Association
American Sexual Health Association
Annie Appleseed Project
Association of Reproductive Health Professionals
Bay Area Perinatal AIDS Center
Care Alliance Health Center
Cascade AIDS Project
Cervical Barrier Advancement Society
Center for Health and Gender Equity
Champaign-Urbana Public Health District
Chicago Female Condom Campaign
Chicago House and Social Service Agency
Chicago Women’s AIDS Project
Chicago Women’s Health Center
CT Center for Patient Safety
Founders Metropolitan Community Church
Gay Men’s Health Crisis (GMHC)
Harlem United Community AIDS Center
Harm Reduction Coalition
HIV Law Project
HIV Prevention Justice Alliance
Houston Area Female Condom Coalition
Illinois Caucus for Adolescent Health
International AIDS Empowerment
International Rectal Microbicide Advocates
ISA Associates, Inc.
JWCH Institute Inc.
Keep the Change
Latino Commission on AIDS
Lifelong AIDS Alliance
Lurie Children’s Hospital of Chicago
Midwest AIDS Training and Education Center
Minnesota AIDS Project
Mujeres Latinas En Accion
National Alliance of State and Territorial AIDS Directors
National Coalition of STD Directors
National Female Condom Coalition
National Minority AIDS Council
National Women’s Health Network
Northern Manhattan Perinatal Partnership
Pediatric AIDS Chicago Prevention Initiative
People of Color Against AIDS Network
Planned Parenthood Greater Memphis Region
Planned Parenthood Gulf Coast
Planned Parenthood Illinois
Planned Parenthood of the Rocky Mountains
Positive Women’s Network – USA
Positive Women’s Network Philadelphia
Reproductive Health Technologies Project
San Antonio AIDS Foundation
San Francisco AIDS Foundation
Test Positive Aware Network
The Afiya Center
The Red Pump Project
The Women’s Collective
Unity Fellowship Church NYC
Universal Light Ministries, Inc.
Women With A Vision
Cc: Marsha Henderson, MCRP, Assistant Commissioner for Women’s Health, Office of Women’s Health, Food and Drug Administration
 The FDA has approved two female condom products, both of which are manufactured by the Female Health Company (FHC). The FC1 female condom was approved in 1993 and the FC2 female condom in 2009. The FC2 female condom is the same design as the FC1, but is made with a different material that allows for lower manufacturing cost. Shortly after the FC2 product was approved, FHC stopped manufacture of the FC1. The FC2 is the only FDA-approved female condom today.
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