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Female Condom Redesign Gets FDA Panel Endorsement

This article was originally published in The Gray Sheet

Executive Summary

The Female Health Company's update of its Reality female condom, which uses a different material and manufacturing process to lower costs, should be approved by FDA contingent upon a single labeling change, the agency's Obstetrics and Gynecology Devices Panel recommended Dec. 11

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Female condom approved

The Female Health Company is building manufacturing capacity for its second generation FC2 female condom after receiving PMA approval March 11. The device is cleared to prevent pregnancy, HIV/AIDS and other sexually transmitted infections, and is expected to cost up to 30% less than the firm's original FC female condom. The company hopes that the lower price will boost sales to HIV prevention programs in the U.S. and globally. While the device is currently available overseas and FHC has the capacity to make 30 million units annually, it is aiming to boost production to 75-80 million units a year, the company states. FC2 approval was recommended by FDA's Obstetrics and Gynecology Devices Panel Dec. 11 (1"The Gray Sheet" Dec. 15, 2008, p. 14)

Female condom approved

The Female Health Company is building manufacturing capacity for its second generation FC2 female condom after receiving PMA approval March 11. The device is cleared to prevent pregnancy, HIV/AIDS and other sexually transmitted infections, and is expected to cost up to 30% less than the firm's original FC female condom. The company hopes that the lower price will boost sales to HIV prevention programs in the U.S. and globally. While the device is currently available overseas and FHC has the capacity to make 30 million units annually, it is aiming to boost production to 75-80 million units a year, the company states. FC2 approval was recommended by FDA's Obstetrics and Gynecology Devices Panel Dec. 11 (1"The Gray Sheet" Dec. 15, 2008, p. 14)

WISCONSIN PHARMACAL REALITY FEMALE CONDOM: LIMITED SHIPMENTS WILL BEGIN

WISCONSIN PHARMACAL REALITY FEMALE CONDOM: LIMITED SHIPMENTS WILL BEGIN in the next 8-10 weeks to facilities with patient populations that are at high risk for unintended pregnancy and sexually transmitted diseases, according to the Jackson, Wisconsin- based company. The female condom, which gained FDA approval on May 7, will be shipped "on a priority basis" to clinics, physicians and STD outreach centers, Wisconsin Pharmacal says in a May 10 release. A four-to-five member technical advisory board comprised of clinical investigators and behavioral scientists will determine which facilities have the greatest need for the devices. Full-scale distribution to pharmacies will not begin until after Wisconsin Pharmacal has gained FDA approval to sell Reality condoms made in England by Chartex International, which markets the device overseas and from which Wisconsin Pharmacal licenses U.S., Canadian and Mexican marketing rights. Wisconsin Pharmacal plans to submit an application to FDA for approval of Chartex as a manufacturer "within the next few weeks" and hopes that it can begin national distribution by year-end. The condoms sold during the limited distribution period will be manufactured at a Wisconsin Pharmacal facility. The company plans to initiate "a broad education program to health care professionals working with women at risk [of] unintended pregnancy and STDs." This program will include nationwide distribution of informational kits. The firm also will sponsor a series of symposia and interactive workshops for the targeted health care providers. Reality will be sold at a retail price of $2.50 each in pharmacies and other commercial outlets, according to the company. The condom will be available at reduced cost to public sector clinics and agencies. Reality, which had been granted an "expedited" review by FDA, was cleared for marketing 10 days after the agency told the firm that the device was "approvable" if certain labeling conditions were met. FDA stipulated that the labeling contain information on the efficacy of the female condom compared to other barrier contraceptives. In addition, FDA required Reality labeling to include language promoting the use of male latex condoms, which cannot be used simultaneously with the female condom. Final approved labeling includes the following statements: "Latex condoms for men are highly effective at preventing sexually transmitted diseases, including AIDS (HIV infection), if used properly" ** "If you are not going to use a male latex condom, you can use Reality to help protect yourself and your partner" ** "Reality only works when you use it. Use it every time you have sex" and ** "Before you try Reality be sure to read the directions in the box and learn how to use it properly." Also included in the labeling is a chart citing the six-month and one-year pregnancy rates for Reality and other barrier contraceptives. The chart says that the six-month pregnancy rate for Reality is 13%, compared to 8% for the male latex condom and diaphragm, 10% for the cervical cap, and 12% for the sponge. The one-year pregnancy rate for Reality listed in the chart is 26% versus 15% for the male latex condom and diaphragm, 18% for the cervical cap and 17% for the sponge. Wisconsin Pharmacal had disputed the 26% one-year rate, which FDA determined by doubling the 13% figure derived from a six-month trial. Instead, the firm maintained that the one-year rate is 21%. After discussions, the agency and the company agreed that the 26% rate would appear in the chart but that labeling also would include the statement: "The estimated [one-year] pregnancy rate for Reality ranges from 21% to 26%. This means that about one in four women who use Reality may become pregnant during a year."

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