FDA panel gives nod to updated female condom.(NEWS)

GAITHERSBURG, MD. -- In a unanimous decision, the second-generation Reality female condom was recommended for approval by the Obstetrics and Gynecology Devices Panel of the Food and Drug Administration.

After much spirited deliberation, the 14 members of the panel agreed that research from the manufacturer (the Female Health Co.) and from an FDA review team provided enough evidence that the new version (FC2) is comparable with the original (FC1) in the protection of women from sexually transmitted infections (ST1), including HIV, as well as from pregnancy. The panel recommended approval with a condition that packaging reflect that the Female Health Co. did not provide any new research about ST1 and pregnancy rates are based on research from the FC1 but that the FC2 was considered comparable. The FDA generally follows the advice of the panel.

Mary Ann Leeper, Ph.D., the senior strategic adviser for the Female Health Co., addressed those concerns during the meeting and explained that it would take nearly 5 years to gather, prepare, and present the contraceptive and ST1 data that the FDA was originally asking about. She also noted that the condoms are virtually the same. "It looks the same, it acts the same, it has the same rate of failure," she said. Dr. Leeper explained that such a delay would prevent the less-expensive FC2 from being available on the U.S. and international makers to women who most need it.

The FDA approved the first and only female condom, the Reality Female Condom (FC1), in 1993. Since then, 165 million female condoms have been sold in 145 countries. Dr. Leeper said . "This product does perform physically the same way as FC1." She argued that the FC2 should be approved because it is based on the same studies that led to the approval of the first condom. She reported a 30% decrease in manufacturing costs that she said will get passed on to consumers.

Dr. Leeper and other representatives from the Illinois-based Female Health Co. research team explained that the design has remained the same, but the manufacturing process has changed to a more cost-effective and efficient process. Also, the material was changed from polyurethane to nitrile, a less expensive material that withstood the same tests and had similar responses as the FC1, they reported.

A key difference is that there is no longer a seam in the condom where, in the old process, the materials once ...