Saturday, July 11, 2009

New Female Condom Unveiled, Looking for Quick FDA Approval

Chicago-based Female Health Co. (FHC) is the company that manufactures the 2.0 version of the female condom. It is being made with less expensive materials making it more affordable, with estimated prices being up to 30 percent less than their existing model, once it gets FDA approval. Male condoms cost merely quarters in America compared to the female type for a couple of dollars, making the choice between the two nearly obsolete.

In support of a vote, 170 organizations (including many in Chicago where the female condom is made) involved with women’s health, HIV/AIDS, and reproductive health signed a letter last week urging a plan that puts women first by endorsing the use of a “woman-centered response” as well as an affordable option for preventing more than just pregnancy.

The U.S. also sells the female condom at a significantly higher price than in developing countries. The condoms run between $1.15 to $2.75 each in America while overseas they are sold at .80 cents each where they are more popular—nearly 90 percent of the 35 million female condoms sold in 2008 through September were purchased in developing countries.

Birth control pills, the patch, the vaginal ring, cervical cap, sponge, diaphragm, intrauterine device (IUD), or the shot, these are all currently available measures women can take to prevent unplanned pregnancy. But what about those nasty sexually transmitted infections (STIs)? HPV, the human papillomavirus, has been in the news lately because of the risk for cervical cancer in women among other cancers and the only preventative measure for decades has been the male condom. The female condom has also been available since 1993, but is more expensive and is not as popular or widely used as the male version for a variety of reasons. But that may change, as manufacturers have finally unveiled an updated female condom that will hopefully appeal to women and add protection from STIs that they cannot get from any other form of birth control.

A Food and Drug Administration (FDA) advisory panel strongly recommended approval for the condom labeled FC2 (the former version is named FC1) in the United States as early as mid-2009. FC1, which was made of polyurethane and got complaints, including difficulty during insertion, being too noisy or too slippery. FC2 is being made with a cheaper synthetic rubber, which will allow the lower cost and should fix its predecesor's slight glitches. The condom will look the same: two flexible rings (a small one at the closed end to fit over the cervix and a larger one at the open end that rests outside the vagina) connected by a thin sheath of lubricated rubber for infection protection of both partners. The FC2 was approved on the condition that the instructions for use continue to follow that of the FC1 model to ensure the safety and efficiency of the product.

The Pre-Market Approval Application was filed with the FDA in January of this year and after much research, a 15-to-0 vote made the panel’s decision unanimous to recommend the FDA push the product ahead for quick approval. The FDA does take this recommendation into consideration but we are reminded that it is not the only factor that goes into the administration’s decision-making process.

Mary Ann Leeper, Female Health Co.’s Senior Strategic Advisor announces last week in a statement on behalf of the company, “We are very pleased with today's outcome and look forward to working with the FDA as it continues to review our application for the FC2 Female Condom.” Leeper believes that receiving the thumbs up from the panel is still a great accomplishment in taking larger steps towards considerably lowering women’s health risks, “We believe that FHC's second-generation female condom can strengthen the fight against AIDS by expanding affordable access to a woman-initiated HIV prevention method.”

The FDA usually follows the panel’s advice, so Female Health Co. and women everywhere should stay optimistic. The female condom, though previously thought of as unsightly and unpopular in the United States, might just be the saving grace women can use to protect themselves from irritating STI’s as well as more serious conditions such as cancer and the ever-present HIV/AIDS, that affects more women than men on average.

With most developing countries already using a model similar to FC2, the U.S. is the last to follow the crowd and with the FDA’s approval, international approval will be easier to push through. Hopefully by summer 2009, FHC displays will be seen in drugstores, pharmacies, grocery stores, mini-marts, and restroom vending machines everywhere allowing women the chance to protect themselves first.

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