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60+ Doctors and Leading Medical Experts Sign an Open Letter Urging the FDA to Approve First-Ever Drug to Treat Women’s Most Common Form of Sexual Dysfunction, notes Even the Score

August 1, 2014

Persistent gender inequity at FDA has led to 26 approved drugs for men, ZERO for women

WASHINGTON, Aug. 1, 2014 /PRNewswire-USNewswire/ — In the latest call for gender equity in the approval of treatments for sexual dysfunction, more than 60 doctors and leading medical experts from across the country have penned an open letter questioning the Food and Drug Administration’s (FDA) decision to approve 26 drugs marketed for the most common form of male sexual dysfunction compared with ZERO for women’s most common complaint, and calling on the agency to act for women by approving the first-ever drug to treat Hypoactive Sexual Desire Disorder (HSDD), or low desire.

The letter, led by Dr. Michael Krychman, a renowned physician and sex therapist who has been a leading champion of FDA action on a treatment for HSDD, includes 62 signees consisting of gynecologists, psychiatrists, psychologists, nurses and others on the front lines of treating women with the condition. The signees represent a multitude of well-known and influential medical and educational institutions – including the University of Virginia, Johns Hopkins University School of Medicine, Stanford University School of Medicine, George Washington University, Weill Medical College of Cornell University, Warren Alpert School of Medicine of Brown University, Northwestern Memorial Hospital, Boston University School of Medicine, Memorial Sloan Kettering Cancer Center, New York University School of Medicine, University Hospitals Case Medical Center, and Drexel University College of Medicine, among others.

While making it clear that they are not advocating for a particular approved therapy for HSDD, the letter signees specifically cited the convoluted path that the FDA has forced one potential HSDD treatment – called flibanserin – to take in its road toward final approval as an example of the FDA holding treatment options for women to a different standard of risk/benefit consideration than the 26 times they’ve turned over that consideration to men and their health care providers. Flibanserin has been studied for 12 years in clinical trials of more than 11,000 women.

According to the letter: “If the FDA cannot approve this therapy that has met its clinical endpoints in study and is worthy of approval by any other comparison of what has sufficed for the male drugs or countless others, you can imagine our significant concern that if we remain silent, further research and development in the field will terminate. Many of us have completed the clinical trials for the product being reviewed by the FDA, flibanserin, as well as the products in development for this condition. … Can you understand our palpable frustration and growing concern?”

In calling on the FDA to make the approval of a medical treatment for HSDD a “priority action,” the letter signees noted that HSDD has been a medically-recognized condition for more than 30 years, and impacts 1-in-10 women – or some 16 million women in the United States today. Sixteen years after the approval of Viagra for men, women are still waiting for a treatment option of their own.

“When a woman’s health is improved so, too, are her partner’s and family’s,” the letter states.

Susan Scanlan, Chair of Even the Score: A Campaign for Women’s Sexual Health Equity – which launched earlier this year by a diverse group of women’s health and other advocacy organizations to lead the fight for safe, FDA-approved treatment options for HSDD – issued the following statement in support of the letter:

Even the Score applauds all of the medical experts who signed this letter in support of an FDA-approved treatment option for women’s most common sexual complaint. This overwhelming support from doctors, clinicians and other sexual health experts, women and men alike, further underscores that it is time for the FDA to act for women by giving them the right to an approved medical option they can discuss and consider with their health care providers, just as men have been able to do for more than 16 years.”

Supporters of the Even the Score campaign include 20 diverse organizations: American Sexual Health Association; Association of Reproductive Health Professionals; 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; Palatin Technologies; Sexual Medicine Society of North America; Society for Women’s Health Research; Sprout Pharmaceuticals; The Blue Thong Society; The Institute for Sexual Medicine; The Women’s Research & Education Institute; and Trimel Pharmaceuticals.

To learn more about the Even the Score campaign, please visit: www.EvenTheScore.org.

Contact: Jaime Horn, 202.827.7859, Jaime@BlueEngineMedia.com

SOURCE Even the Score


Source: PR Newswire



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