Female condoms recommended for FDA approval Panel still advises additional tests

WASHINGTON — WASHINGTON -- A federal advisory panel recommended yesterday the approval of a condom designed for women -- a device that for the first time will allow women to protect themselves from sexually transmitted diseases in the deadly age of AIDS.

If the condom gets final approval by the Food and Drug Administration, a woman will no longer "have to negotiate with a man or be dependent on a man . . . for protecting her," said Dr. Mervyn F. Silverman, president of the American Foundation for AIDS Research, who has served as a consultant to the manufacturer.


The recommendation by the Food and Drug Administration's Obstetrics and Gynecology Devices panel was conditional, depending on results of additional studies of the condom's effectiveness in preventing pregnancy. So far, such studies have been conducted only on small groups.

Although the FDA still must approve the condom before it can be sold, advisory panel recommendations typically wield considerable influence in agency decision-making.


The condom, manufactured by Wisconsin PharmacalCo. of Jackson, Wis., and Chicago, already has been approved in Switzerland and is expected to be marketed soon in France and Britain.

It has been enthusiastically endorsed by numerous international family planning organizations, women's health organizations and AIDS groups. The U.S. Agency for International Development contributed an estimated $1.5 million to $2 million to support clinical trials.

"Overseas, AIDS is even more of a heterosexually transmitted diseasethan it is here -- and women are even less empowered there than they are in the United States," said James Shelton, chief of the research division of Agency for International Development's office of population. "So anything at all that will help them in this regard is important."

The condom's biggest drawback is expected to be its price. One female condom, for a one-time use, is expected to cost about $2.25, compared to about 70 cents for a condom used by men.

The company estimates that an average year's supply would cost about $180-$190, compared to about $200 or more for birth control pills.

Mary Ann Leeper, head of the company's development team, predicted the additional research would be finished by June or July. If agency approval came soon after, "we could have the product on the shelves, hopefully, by late fall, and certainly by the end of the year."

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 said.

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.