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FDA Panel Gives Conditional Approval to Female Condom

December 11, 1992

WASHINGTON (AP) _ Experts advising the Food and Drug Administration said Thursday a condom for women should be allowed onto the U.S. market but only if it carries a label warning that its effectiveness is questionable.

The FDA usually follows the advice of its advisory panels. There is no timetable for its decision, but it might act before the Clinton administration takes office next month.

The committee made a similar recommendation earlier this year but was called back by the FDA to examine new studies done by the company. The FDA said it was having trouble making a decision based on the information supplied by the company.

The committee had doubts, too.

″If I were explaining this to a friend or a colleague, I’d say it’s not very effective,″ said Dr. Herbert Peterson, a member of the panel representing the Centers for Disease Control.

Nevertheless, the panel agreed that the condom should be conditionally allowed onto the U.S. market.

Among the conditions the panel was working on into the night was wording that would convey a clear sense of how well the condom works.

Peterson said that the studies conducted by the company indicated that one- fourth to one-fifth of the women in the United States who might use the device can expect to get pregnant in the first year.

The panel also found that the label for the condom can make no specific claims about its ability to prevent infection with the AIDS virus. But it should not make claims beyond saying that it can help reduce the risk of AIDS and other STDs transmission.

Wisconsin Pharmacal Co., which makes the device and plans to market it under the brand name Reality, has done a number of tests, both on the condom and people who use it.

The company said tests over six months found a failure rate of 12.2 percent among women in the United States, with failure defined as pregnancy. Commenting on the company tests, the FDA pointed out that the failure rate among women studied in Latin America was almost twice that and among certain age groups, over 30 percent.

The agency said the company may have underestimated the failure rate by as much as 10 percent.

However, the company defended its statistics. It claimed its studies were more stringent than those done for other birth control devices. For instance, the people in the female condom study had sex about 14 times a month.

″They had a lot more sex,″ said Mary Ann Leeper, a company spokeswoman. ″They had a lot more possibility of failure.″

If used correctly, the female condom fails just over 5 percent of the time, the company claimed.

The female condom is an adaptation of the one for men. It is a seven-inch tube with flexible rings at both ends. The inner ring fits behind the woman’s pubic bone, and the outer ring remains outside her body.

The condom has been pumped full of helium, filled with water, shot with lasers and tried in rabbits in the laboratory to see if it irritated the animals. Those tests were fine, the FDA said.

But the results in people were mixed. Some used it better than others. And because of the company’s methods, the condom’s failure rate can’t be compared to that of other birth control methods, the FDA said.

Nevertheless, a number of witnesses Thursday pleaded with the panel to approve the condoms because they would be the only method under the control of women for preventing sexually transmitted diseases, including the virus that causes AIDS.

″Best of all a woman does not have to ask the man to please wear a male condom,″ Julia Scott, director of the National Black Women’s Health Project, told the committee. ″Reality may be inserted long before intercourse, therefore, it does not break the flow of lovemaking the way the male condom can.″

The female condom would be sold as a contraceptive and as a barrier to sexually transmitted disease. In the tests, its effectiveness as a contraceptive is taken to be an indication of how well it would work in preventing sexually transmitted diseases.

However, the FDA pointed out that not every act of sexual intercourse, whether protected or unprotected, results in pregnancy. But any act of sex can transmit disease.

FDA researcher Richard Chiacchierini said that based on tested failure rates, a woman’s probability of exposure to sexually transmitted disease while using a female condom was one in five.

Surveys among American women have found widely varied failure rates for various birth control methods, depending on who is using them, said Jacqueline Forrest, a researcher for the Alan Guttmacher Institute.

Characteristics such as age, income, race, ethnic background, and marital status all were related to the methods’ failure rates, she said.

For birth control pills, the failure varied from 2.8 percent to 26.8 percent and for the male condom it ranged from 6.4 percent to 51.3 percent, she said. They are, respectively, the first and second most used birth control methods in the United States.

The advisory panel in January recommended approval of the condoms, provided that the company’s early claims were confirmed by more recent, larger studies.

The condoms, which would cost $2.25 each, already have been approved for use in parts of Europe.

The company says the device is better than latex condoms used by men because it is made of polyurethane and is less likely to break or leak.

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