President, Center for Health and Gender Equity
When a woman or man suffers from a form of sexual dysfunction, their ability to have a satisfying sex life is curtailed and personal relations with a partner or spouse also can be damaged. The global community’s response to sexual dysfunction should be equal for women and men, but it is not. This year marks 16 years since the introduction of Viagra. Today, the market includes more than 20 drugs to address male sexual dysfunction — and not a single one for women.
The Food and Drug Administration (FDA) has approved 24 drugs to treat some form of male sexual dysfunction (low testosterone, erectile dysfunction, Peyronie’s disease), yet they continue to hold up the approval of just one drug for women — flibanserin. Flibanserin would treat the most common form of female sexual dysfunction — low sexual desire (Hypoactive Sexual Desire Disorder or HSDD).
In the coming weeks, women’s health advocates are awaiting a decision on a dispute taken to the FDA that objects to delays in approving a first-of-its-kind treatment for low sexual desire with accompanying distress in women.
Twenty years ago, 180 countries gathered in Cairo, Egypt for the groundbreaking International Conference on Population and Development (ICPD) — here nations made commitments to advance the sexual and reproductive health and rights (SRHR) of women, men, and young people throughout the world. The Center for Health and Gender Equity (CHANGE) emerged from this conference as an advocacy group to ensure that U.S. commitments to the SRHR agenda were translated into U.S. policies.
Both the ICPD Programme of Action and the Fourth World Conference on Women and Girls Platform for Action (Beijing, 1995) articulate that individuals should be able to have safe and satisfying sex lives. Sexual health services, according to these two global consensus documents, should be more than just counseling and care related to reproduction and sexually-transmitted diseases. Understanding sexuality to be a critical human need, the international consensus aims higher: sexual health includes the enhancement of life and personal relations.
A drug that addresses HSDD would enhance life and personal relations for women who suffer from low sexual desire. Without a doubt, there is a need for safe and effective treatment for female HSDD, yet none has ever been approved. But now, we have a product before the FDA and the application must be taken seriously.
CHANGE is not endorsing any one product under pending application for female sexual dysfunction. However, we believe that a thorough review and re-consideration of flibanserin is due. Certainly the fact that numerous treatments have been approved by the FDA and made available for men, while none have ever been approved for women, should raise questions.
No single drug will ever be a cure-all for any condition, and will not be the choice for all women. It is only fair that women have choices to address sexual dysfunction as men do.
The FDA should remember the commitment made by the U.S. government to the global community — and to the women of the world — to support the ability of individuals to have a satisfying sexual life. The FDA should closely examine the extensive data package that has been submitted and make a decision that would be in the best interest of women, thereby keeping the door open for women’s sexual health, pleasure and life enhancement.