Coalition urges FDA Advisory Committee to make #HERstory by recommending approval of flibanserin
WASHINGTON, June 1, 2015 – As the Food and Drug Administration (FDA) prepares this week to consider what would be the first-ever medical treatment for women’s most common sexual dysfunction, known as Hypoactive Sexual Desire Disorder (HSDD), Even the Score urged the Agency to make #HERstory by recommending approval of flibanserin and opening the pipeline for future treatment options to come.
The coalition of more than two-dozen women’s rights and women’s health groups called Thursday’s upcoming Advisory Committee meeting on flibanserin a “pivotal moment for women’s health,” as the committee’s recommendation will have historic repercussions – not only for the 1-in-10 women who are living with HSDD without a single approved medical treatment for their condition but also on the availability of future options for women’s sexual health.
“Women deserve the safety and peace of mind that comes with access to FDA-approved medical treatments for HSDD. And they’ve spent the past year making their voices heard – telling their stories of struggle with HSDD and of why sexual pleasure matters to them. This week’s FDA Advisory Committee meeting represents a pivotal moment for women’s health,” said Susan Scanlan, Chair of Even the Score and Chair emerita of the National Council of Women’s Organizations. “Even the Score applauds FDA’s recognition of female sexual dysfunction as a key unmet medical need, and urges the Advisory Committee to make HERstory this week. We look forward to standing in support as the FDA acts for women and recommends approval of the first ever treatment option for HSDD.”
While Even the Score does not advocate for the approval of any individual drug, as the first HSDD medical treatment in a pipeline that must be opened, the coalition believes that flibanserin deserves the Agency’s fair consideration. Flibanserin has been tested in more than 11,000 women – making it one of the most studied women’s health products in history; its safety is well characterized, as the most common side effects include dizziness, sleepiness and nausea; and the women in the trials themselves said the effects were “meaningful” using the scientific tool that the FDA required.
The FDA has already recognized the importance of this unmet medical need, hosting a landmark two-day public forum last October on female sexual dysfunction that featured testimony from a packed house of patients, clinicians and advocates. During that meeting, the FDA stated that the Agency “recognizes that this is a condition that can greatly impact the quality of life” and “is committed to supporting the development of drug therapies for FSD (female sexual dysfunction).”
Over the last year, there has been a steady drumbeat of support for female sexual dysfunction treatment options from lawmakers, women’s rights groups, medical experts and consumer organizations. In March, 11 members of Congress sent a letter to then-FDA Commissioner Margaret Hamburg noting the gender disparity in FDA-approved medical treatment options for sexual health, and urging the agency to “continue your focus on providing women with safe and effective treatments they need and deserve.” Last month, U.S. Rep. David Price (D-N.C.) sent a similar letter to the FDA encouraging it to act for women, a follow-up to his 2014 letter on the same issue. And last year, four Congresswomen voiced their concerns about the lack of sexual dysfunction treatment options for women.
Leaders from the National Organization for Women, the National Consumers League, the International Society for the Study of Women’s Sexual Health, the Memorial Sloan-Kettering Cancer Center and the CHANGE: Center for Health and Gender Equity have also penned letters to the FDA raising similar concerns with the Agency’s failure to provide treatment options to women struggling with sexual dysfunction.
Supporters of Even the Score include: American College of Nurse-Midwives; American Sexual Health Association; Association of Reproductive Health Professionals; Black Women’s Health Imperative; CHANGE: Center for Health and Gender Equity; EmpowHER; HealthyWomen; HisAndHerHealth.com; International Society for the Study of Women’s Sexual Health; Jewish Women International; National Council of Women’s Organizations; National Women’s Health Resource Center; Middlesex MD; National Association of Nurse Practitioners in Women’s Health; National Hispanic Medical Association; Sexual Medicine Society of North America; Society for Women’s Health Research; Sprout Pharmaceuticals; Red Hot Mamas; The Blue Thong Society; The Institute for Sexual Medicine; The Women’s Research & Education Institute; and Trimel Pharmaceuticals.
To learn more about the work of Even the Score: www.EvenTheScore.org.