Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: SATURDAY, February 1, 1992 TAG: 9202010176
SECTION: NATIONAL/INTERNATIONAL PAGE: A-12 EDITION: METRO
SOURCE: Los Angeles Times
DATELINE: WASHINGTON LENGTH: Medium
PANEL WANTS CONDOM FOR WOMEN APPROVED
A federal advisory panel recommended approval Friday of a condom designed for women - a device that for the first time would 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 would 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 panel on obstetrics and gynecology devices was conditional, depending on the 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 Pharmacal Co. 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 of the device.
Mary Ann Leeper, head of the company's development team, said the company already had begun an expanded study and predicted the research would be finished by June or July.
If agency approval came soon after, the product could be sold by the end of the year, she said.