Second generation of female condom receives FDA committee approval
Second generation of female condom receives FDA committee approval
Next for FDA review: Package label and package insert language
When the female condom first gained Food and Drug Administration (FDA) approval in 1993, women's health advocates hailed it as a form of female-controlled protection; however, use of the method has been underwhelming among American women since its introduction.
One roadblock to use has been the device's high manufacturing cost. The original female condom, known as the Reality or FC1 female condom, is made of polyurethane. Due to the manufacturing process involved in making the FC1, its price, approximately 72 cents per unit, could not be affected by bulk purchasing. The new generation, known as the FC2, is made of nitrile, carries a less expensive manufacturing cost, and can be made available for as little as 22 cents per unit in bulk-purchasing programs.1
The FC2 condom, available in 77 countries, has gained backing from a U.S. Food and Drug Administration (FDA) advisory panel. The agency is not bound by the committee's recommendation, but it does take its advice into strong consideration when reviewing potential products.
What is the next step in the FDA regulatory process for the condom, manufactured by the Chicago-based Female Health Company? The company is working with the FDA to finalize an approvable package label and package insert language, says Mary Ann Leeper, PhD, the company's senior strategic adviser. It expects the process to take several months, she adds.
In developing the FC2 condom, the company wanted to find a material that would allow it to switch from a more costly welding process to a dipping process, much like the dipping process used to make male condoms, explains Leeper. The replacement of polyurethane with nitrile, a synthetic rubber, allowed the company to make that switch, she notes. "As a result, the FC2 female condom does not have a welded seam, and its outer ring is rolled, not welded," states Leeper. "The new material and dipping process allow for increased output, and they reduce material and labor expenses."
Will women with a latex allergy be able to use the FC2 condom? Yes, says Leeper. "We are not aware of any allergies to the FC2 nitrile compound," Leeper states. "It is similar to the material used in synthetic latex surgical gloves, used by people allergic to latex."
Will the company continue to make the original FC1 condom available in the United States if the FC2 condom receives FDA approval? "We are transitioning all FC1 purchasers to FC2 as soon as regulatory agency requirements are met around the world, including the U.S.," says Leeper. "We will ultimately stop the manufacture of FC1."
Is it safe and effective?
At a December 2008 meeting of the FDA's Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee, committee members reviewed the Female Health Company's pre-market approval application for the FC2 female condom for prevention of HIV/AIDS and unintended pregnancy. The company filed the pre-market approval request in January 2008.
The pivotal study presented for the FDA review was a multicenter, crossover, randomized trial conducted in South Africa.2 The trial was designed to compare clinical failure modes for the FC1 and FC2 condoms. More than 200 women completed the study, with a total of 1,910 FC1 and 1,881 FC2 condoms used. Total clinical failure was 5.24% in FC1 and 4.3% in FC2.2 The 18th edition of Contraceptive Technology lists the perfect use failure rate for the female condom (FC1) as 5%, and typical use as 21%, with 49% of women continuing use at one year.3
A 2006 review of the second-generation synthetic latex female condom by the World Health Organization's Department of Reproductive Health and Research concluded that the design and physical characteristics of FC2, supported by the clinical data, suggest that the two devices are functionally equivalent, when used correctly.4 The committee's review ruled that the FC2 is acceptable for bulk procurement by United Nations agencies. Since then, more than 22 million FC2 female condoms have been distributed in 77 countries, according to the Female Health Company.
New look boosts use
Mayer Laboratories of Berkeley, CA, is the exclusive retail distributor of the FC1 condom in the United States. It markets the product as the fc female condom. The fc female condom retails from $13.99-$16.99, says Jenice Urcuyo, assistant general manager at Mayer Laboratories. The condom also is available for order through a link on the product's web site, www.fcfemalecondom.com. Click on "fc female condom," then click on "Purchase." A package of three is $10, with a package of five listed at $15.
In 2008, the company redesigned the product's packaging, launched new advertising, and established the product's dedicated web site. What led to the change? Historically, the fc female condom package was similar to many pharmaceutical products and exhibited a strong clinical feel, explains Urcuyo. Its shelf appearance lagged considerably behind male condoms and other consumer products. After considerable thought and market information, Mayer Laboratories elected to take the product package design into the 21st century, says Urcuyo.
The fc female condom advertising campaign reinforces the product message, focusing on three mediums: a new web site, print advertisements, and retailer shelf promotions, states Urcuyo. The web site focuses on "smart-and-sexy" information, which allowed those without prior knowledge of fc female condoms to learn about the product, while being clear that fc female condoms are a part of sex and intimacy, she explains. The print ad goes beyond the public health message to "use as protection against pregnancy and sexually transmitted diseases." It also promotes the sexual satisfaction that will come from using the product, similar to how male condoms are advertised today, says Urcuyo.
"We immediately saw an increase in retail sales coinciding with the launch of the new package and ads," states Urcuyo. "For example, at Rite Aid, sales increased over 10% in the first three months of the new package and the promotion program."
While Mayer Laboratories has been selling the fc female condom on its web site since 2001 for consumers who could not locate the product at their local drugstores, it decided to establish a separate web site for the fc condom as an information resource, says Urcuyo. It has received overwhelming support from customers and consumers, she reports.
"Our unique features, "fc stories" and "fc questions," have especially received positive feedback, and consumers are definitely taking advantage of these forums. We can't keep up with the number of submissions we receive," states Urcuyo.
Female method is needed
The female condom offers numerous benefits: Its use does not rely on the assistance of a health care provider, it is immediately reversible, and it has few to no side effects, says Beth Jordan, MD, medical director of the Association of Reproductive Health Professionals (ARHP).
As with any contraceptive method, with solid education from a health care provider or other trusted source, a female condom can be used very effectively, states Jordan, who testified on behalf of ARHP at the FDA December 2008 committee hearing.
Female condoms are the only existing female-initiated and controlled HIV prevention method, states Jordan. When used consistently and correctly, female condoms offer between 90%-97% risk reduction of HIV infection,5 she notes. In addition to serving as a safe and effective method protecting against HIV, sexually transmitted infections, and pregnancy, studies show that effective promotion and use of the female condom results in a significant increase in the total number of protected sex acts between partners.6 Because it remains the only female-controlled HIV prevention tool, women who can't negotiate condom use with their male partners will especially benefit from the availability of a female condom, says Jordan.
In the absence of an effective HIV vaccine or microbicide, public health officials need to think more seriously about female condoms, says Robert Hatcher, MD, MPH, professor of gynecology and obstetrics at Emory University School of Medicine in Atlanta. Female condoms are available now; they are not a promise on the horizon, he says.
"There needs to be an increase in funding and programs to expand access to this female-initiated method which offers a protection option for women," says Hatcher. "The markedly lower price of the new female condom may facilitate its use more widely in the prevention of HIV and other infections."
References
- Female Health Company. Female Health Company Announces International Availability Of Second-Generation Female Condom At Significantly Lower Price. Press release. Sept. 29, 2005. Accessed at www.femalehealth.com/Investor.
- Beksinska M, Smit J, Mabude Z, et al. Performance of the Reality polyurethane female condom and a synthetic latex prototype: A randomized crossover trial among South African women. Contraception 2006; 73:386-393.
- Trussell J. "Choosing a contraceptive: efficacy, safety, and personal considerations." In: Hatcher RA, Trussell J, Nelson AL, et al. Contraceptive Technology: 19th revised edition. New York City: Ardent Media; 2007, p. 24.
- World Health Organization. Female Condom Technical Review Committee. Summary Report On FC2. Accessed at who.int/reproductive-health/publications/fc2/fc2report.pdf.
- Trussell J, Sturgen K, Strickler J, et al. Comparative contraceptive efficacy of the female condom and other barrier methods. Fam Plann Perspect 1994; 26:66-72.
- Vijayakumar G, Mabude Z, Smit J, et al. A review of female-condom effectiveness: Patterns of use and impact on protected sex acts and STI incidence. Int J STD AIDS 2006; 17:652-659.
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