WASHINGTON, Feb. 11, 2014 /PRNewswire-USNewswire/ -- In response to the U.S. Food and Drug Administration's (FDA) decision to further delay approval of the first-ever drug to treat the most common female sexual disorder, the National Consumers League and the National Organization for Women, joined by women's health and advocacy organizations, are calling on the FDA to move swiftly to end the 16 year wait for women in treatment of sexual dysfunction. The FDA has approved 24 drugs for the treatment of male sexual dysfunctions -but has yet to approve a single treatment for women suffering from distressing low sexual desire.
This decision - which is critically important for women's health and well-being - came as a result of a dispute filed with the FDA to reconsider their two time position that they need more data to support approval of a medication to treat HSDD. This treatment has been studied in clinical trials with 15x the median number of patients for new drug approvals between 2005-2012 at the FDA, according to data from the Journal of the American Medical Association. Over 11,000 women in clinical trials for a medical treatment for HSDD is more than any approved male sexual health drug. In fact, the 24(th) drug approval for male sexual dysfunction came just months ago with only 832 subjects and a serious set of side effects like penile rupture or other serious injury to the penis.
"This FDA decision is an unfortunate setback, requiring the only promising treatment for female sexual dysfunction to jump through more unnecessary hoops. It also suggests that a double standard exists for evaluating drugs to treat women for low sexual desire; that said, we will hope to see an approved medical treatment for HSDD -for women sometime in the coming year," said Sally Greenberg, Executive Director of the National Consumers League.
"The National Organization for Women has a long history of looking at the standards by which FDA approves drugs for women and there is clearly a bias here. When it comes to approving drugs for male sexual dysfunction, the FDA says yes with more limited research and serious side effects, but when it comes to women, their go-slow tactics are preventing us from having access to a treatment option where we make the decision in consultation with our healthcare provider," said Terry O'Neill, President of the National Organization for Women.
This week's decision comes after advocacy organizations such as the National Consumers League, the National Organization for Women and the National Council of Women's Organizations commenced a dialogue with the FDA over women's need for a safe and effective treatment and the far reaching implications their decision would have. A group of advocates met with officials at the FDA in January to discuss their concerns about the lack of safe and effective treatments for women. "This request for even more testing, more time, in short, more hurdles, to bring this treatment to women seems inconsistent with the standards that other drugs are held too, particularly male sexual drugs," Greenberg and O'Neill added.
In January, the International Society for the Study of Women's Sexual Health released a poll revealing that almost two-thirds of American women believe that it's inappropriate that the score is 24-0 when it comes to federal approval of treatments for desire, arousal or orgasm dysfunction in men vs. women. The poll, conducted by Public Policy Polling, also found that 54 percent of respondents say that drug treatments for women should not be held to stricter standards for approval than men's sexual health drugs.
Groups Supporting Treatment for Women's Sexual Disorder:
American Sexual Health Association (ASHA)
Association for Reproductive Health Professionals (ARHP)
Black Women's Health Imperative (BWHI)
Center for Health and Gender Equity (CHANGE)
International Society for the Study of Women's Sexual Health (ISSWSH)
Jewish Women International (JWI)
National Consumers League (NCL)
National Council of Women's Organizations (NCWO)
National Hispanic Medical Association (NHMA)
National Organization for Women (NOW)
Nurse Practitioners in Women's Health (NPWH)
Society for Women's Health Research (SWHR)
Contact: Jessica Borchert
SOURCE National Consumers League