First FDA Decision on Contraception After the Election…Coming Soon!

Female condoms may soon be more available and affordable for women in the United States and around the world, if the Food and Drug Administration (FDA) follows the recommendation made by its advisory committee. On December 11, the FDA convened a group of medical and scientific experts to consider a new version of the female condom (FC2), and the committee voted unanimously to recommend approval.

NWHN Executive Director Cindy Pearson spoke during the public comment section of the meeting, urging the committee to approve the new condom for use in the United States. Many women’s health advocates – including both HIV/AIDS activists and reproductive rights groups, those who work in the United States and people whose focus is global — joined Pearson in speaking in support of approval at the meeting. One speaker presented a letter advocating for FC2 approval that had been signed by more than 100 advocacy organizations. The letter sent a clear message that women around the world want and need FC2 to expand the HIV prevention tools at their disposal: “The feminization of HIV and AIDS requires a woman-centered response and access to a range of safe, effective, and affordable prevention methods for women — including female condoms and effective education on their use – can play a strong role in stemming the number of new HIV infections.[…] Female condoms are tools women can use right now — today — to protect themselves against HIV and other STIs.” During the committee’s deliberations several advisory committee members noted that the urgent concern articulated for the health of women around the world gave vital public health significance to the agency’s decision about this product.

In addition to responding to the questions the FDA raised about the data supporting FC2’s effectiveness, Pearson recounted the regulatory history of the female condom, noting that the NWHN played a key role in the approval process of the original female condom. (You can read the NWHN’s full statement from the meeting on our website.) The NWHN’s female condom advocacy was critical, Pearson explained, in “prodding FDA to require clinical trials in the first place, educating FDA about the usefulness of a barrier device with less than perfect effectiveness and coming to consensus with the contraceptive development community about a new FDA guidance for clinical trials of barrier contraceptives.”

The new female condom has been reviewed by the World Health Organization and found to be similar in safety and effectiveness to the first generation product. Because the new version can be manufactured at a lower cost, public sector health programs expect to be able buy more of them and to supply them more consistently to women who want them. A lower retail price can also make this tool for preventing pregnancy and sexually transmitted infections (STIs) more accessible to women who are looking for an over-the-counter method that they can initiate.

Women and girls are more vulnerable to being infected by HIV and other STIs than men both for biological reasons and because they are sometimes unable to negotiate with male partners who don't want to use condoms. Prevention options that women can initiate, like female condoms, make it possible for a woman or girl to take action to protect herself. The NWHN now urges the FDA to follow its committee’s advice. Approval of a safe, effective, and less expensive female condom is an important step in giving woman another option for protecting their health and preventing unintended pregnancy. To email the FDA to support approval of the new female condom, go to http://www. nwhn.org/alerts/details.cfm?email_message_id=215.