FDA to Approve Female Condom, Push Male Type

The Food and Drug Administration said Tuesday that it is prepared to approve the first condom-like device for women, but the agency emphasized that there has been no research to show whether it is as effective as the male condom for protection against sexually transmitted diseases such as AIDS.

The agency also said the pregnancy rate for users is higher than the rates for the male condom and for other women’s barrier contraceptives.

Upon approval--which is expected to be announced later this week--the female condom will be required to carry labeling stressing that for “highly effective protection” against sexually transmitted diseases, it is important that the male partner use a latex condom, the agency said.

“The female condom is not all we would wish for, but it is better than no protection at all,” FDA Commissioner David A. Kessler said. “I have to stress that the male latex condom remains the best shield against AIDS and other sexually transmitted diseases. Couples should go on using the male latex condom.”

Nevertheless, a condom for women is considered a significant option for those whose male partners refuse to wear condoms.

Manufactured by Wisconsin Pharmacal Co. of Jackson, Wis., and Chicago, the condom already is being sold in England, Switzerland, Austria, Portugal, the Netherlands and Norway.

The device has the support of numerous international family planning organizations, women’s health organizations, AIDS groups and other bodies, including the Agency for International Development, which has funded clinical trials of the device.

The condom, which will be sold under the name Reality, consists of a loose-fitting, lubricated polyurethane sheath and two flexible polyurethane rings. It can be used with additional lubricant, but does not require a spermicide, the company says.

One of the rings lies inside at the closed end of the sheath and serves as an insertion mechanism and internal anchor. The other ring forms the external edge of the sheath and remains outside the vagina after the sheath is inserted. Once in place, the device covers the labia and the base of the penis during intercourse.

In addition to endorsing the safety of latex male condoms, the FDA said the product’s labeling will also be required to describe the pregnancy rate for female condom users, which is about 26% per year, compared to the rates of other women’s barrier contraceptives, which are lower.

The diaphragm and cervical cap have a failure rate of about 18%, whereas the male condom has a failure rate of about 12%. The cervical cap and diaphragm, however, offer no protection against sexually transmitted diseases.

The company also will be required to conduct additional effectiveness studies of the product.

Dr. Mary Ann Leeper, the company’s senior vice president for development, said the device would be made available first to family planning and AIDS clinics on a priority basis within eight weeks after approval.

General distribution in the United States will depend on how quickly the FDA can inspect the company’s British plant, she said, predicting that it would take several months.

Like the male condom, the female condom will be available in drugstores and will not require a prescription.

“We have worked hard with the FDA to complete the necessary documentation (and) discussions are ongoing to finalize the product labeling,” she said. “Recently, public health agencies have initiated a new campaign to increase awareness that latex male condoms are effective at preventing STDs (sexually transmitted diseases), including AIDS. Once approved, women will be able to use the Reality female condom. This is important when the male condom is not an option.”

She acknowledged that male condoms are effective in preventing sexually transmitted diseases but stressed that the partners of many women fail to use them. Thus, she said, “this is a critical option for women.”

The FDA said its decision to approve the condom for marketing was based on a review of clinical data submitted by the manufacturer and the unanimous recommendation of its Obstetrics and Gynecology Devices advisory panel last December.

But the FDA said that it had reservations about the limited data available on the protection it offered against diseases, as well as about the high pregnancy rate among users, the small number of women studied in the clinical trials and the short duration of the studies.

The company studied 200 women who used the device for six months, the FDA said. In the study, the six-month pregnancy rate among U.S. women would equal 26% for a whole year.

“This high rate is believed to have been the result of improper use of the device,” the FDA said. “It compares to an expected rate of 85% among women not using any contraceptive method. Women who use the device correctly each and every time they have intercourse can expect a much lower pregnancy rate.”

The condom’s price is expected to be another drawback. One female condom, for a one-time use, is expected to cost about $2.50, contrasted with about 70 cents for the male condom.

Company officials have said, however, that they plan to provide bulk sales discounts to U.S. family-planning clinics and to the Agency for International Development for overseas distribution.