Even The Score Marks 17th Viagra Anniversary with Release of New Letter from Members of Congress to FDA Calling for Equity in Sexual Health

WASHINGTON, March 26, 2015 /PRNewswire-USNewswire/ -- Even the Score today marked this week's 17^th anniversary of the Food and Drug Administration's landmark approval of Viagra with the release of a new letter from 11 members of Congress calling on the Agency to begin restoring gender equity in sexual health by approving a first-ever medical treatment for women's most common sexual dysfunction.

Currently, men have access to 26 FDA-approved medical treatment options for sexual dysfunction – while women have zero biological treatment options for their most common complaint, Hypoactive Sexual Desire Disorder (HSDD), despite the fact that it affects 1-in-10 American couples.

The congressional letter to the FDA, led by U.S. Rep. Jackie Speier (D-Calif.) and signed by U.S. Reps. Don Beyer (D-Va.), Katherine Clark (D-Mass.), Lois Frankel (D-N.Y.), Raúl M. Grijalva (D-Ariz.), Doris Matsui (D-Calif.), Gwen Moore (D-Wis.), Ed Perlmutter (D-Colo.), Lucille Roybal-Allard (D-Calif.), Juan Vargas (D-Calif.) and Frederica Wilson (D-Fla.), noted that over the past year, "The call for gender equity in the approval of treatments for sexual dysfunction has grown louder, with some of the nation's most prestigious women's health and other research groups voicing serious concerns about this disparity."

Congresswoman Speier's letter adds to a growing chorus of members of Congress who have called on the FDA to act for gender equity in sexual health. Last year, Congresswomen Debbie Wasserman Schultz (D-Fla.), Chellie Pingree (D-Maine), Nita Lowey (D-N.Y.), and Louise Slaughter (D-N.Y.) wrote to the FDA that they believe "approval of a drug to treat female sexual dysfunction that women could access can have a beneficial impact on the lives of millions of American women and men." Similarly, Congressman David Price (D-N.C.) wrote his own letter to the FDA on the issue, as did multiple prominent women's health and women's advocacy organizations that later went on to form the Even the Score coalition.

This new letter notes that the FDA gave priority review to Viagra when its drug approval application was before the Agency, despite serious side effects, on the basis that it addressed an unmet need. By comparison, the drug currently being considered by the FDA as a potential first-ever treatment for women's HSDD – called flibanserin – "has not been afforded the same priority despite having much less severe side effects," which most commonly include sleepiness, dizziness and nausea. This denial came despite the FDA itself declaring female sexual dysfunction as a key unmet medical need. Last month, Sprout Pharmaceuticals resubmitted flibanserin to the FDA for potential approval.

"We firmly believe that equitable access to health care should be a fundamental right, regardless of whether you are a man or a woman. But when it comes to sexual health – and, in particular, sexual dysfunction – that's just not the case," the members wrote to the FDA.

Last fall, the FDA – recognizing the real need for medical treatment options for women – hosted a landmark two-day public forum 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)."

"In the 17 years since FDA approval of Viagra for men, options for the treatment of male sexual dysfunction have multiplied. Yet women continue to struggle without a single FDA-approved medical option of their own. This gender disparity has gone on long enough. The FDA has recognized the importance of this unmet medical need. Last fall, they heard firsthand from women living with Hypoactive Sexual Desire Disorder about the negative impact of the condition on relationships and, by extension, on entire families. The Agency now has the opportunity to act positively for women by approving the first-ever medical treatment for HSDD and opening the field of research for a variety of treatment options to come," said Susan Scanlan, Chair of Even the Score and Chair emerita of the National Council of Women's Organizations.  

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; Palatin Technologies; 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.

SOURCE Even the Score

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