THE BUZZ

The Buzz

Women’s Groups Applaud FDA’s Game-Changing Decision for Women’s Sexual Health

Over the last year, there has been a steady drumbeat of support for FDA-approved women’s sexual dysfunction treatment options from lawmakers, women’s rights groups, medical experts and consumer organizations. Here’s what some of our Even the Score members have to say about today’s decision by the FDA to approve flibanserin, a victory for women and a huge step forward in women’s sexual health:

National Organization for Women Welcomes FDA Decision on Women’s HSDD Treatment

“The Food and Drug Administration did the right thing by approving the first- ever medical treatment for women’s most common sexual complaint and we hope that other safe and effective treatments will be approved. Hypoactive Sexual Desire Disorder (HSDD) is a serious condition experienced by about ten percent of pre-menopausal women, yet it has taken seven years for this drug, flibanserin (Addyi), to get the green-light.

“The National Organization for Women (NOW) insists on the right of women with HSDD to be taken seriously and to have treatment options that improve their health and quality of life. Women – no less than men – deserve to have satisfactory sexual experiences and fulfilling intimate relationships.”— Terry O’Neill, President, NOW

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NCL lauds FDA approval of first treatment for low libido in women

Today the National Consumers League (NCL) commends the U.S. Food and Drug Administration (FDA) for its approval of the first-ever treatment for women’s low libido. The drug comes nearly four decades after the condition of HSDD (Hypoactive Sexual Desire Disorder)—which it has been approved to treat—was recognized in scientific journals. NCL has been calling for FDA to consider the treatment option because it would be the first of its kind for women; there are 26 drugs on the marketplace available to treat male sexual dysfunction.

In October 2014 and June 2015, NCL’s Executive Director Sally Greenberg testified in support of treatments for patients suffering from HSDD. The following statement may be attributed to Greenberg:

“This is the biggest breakthrough in women’s sexual health since the advent of ‘the Pill.’ Men have 26 different drugs available to treat sexual dysfunction. Now, with this drug’s approval, women finally have one. That’s a start. We hope to see competitor treatments that will offer women suffering from HSDD the same kinds of options available to men.

“We have been hoping for approval of the first-ever drug to treat HSDD for several critical reasons. Once there’s an FDA treatment available, women are less likely to purchase untested and possibly dangerous products online. The FDA’s rigorous testing ensures that drugs tested in clinical trials that include thousands of women won’t carry harmful and unknown side effects. Secondly, once a treatment is approved by the FDA there will be other companies coming forward with competitor drugs, and that gives women choices, which we strongly support.

“We are pleased that women suffering from HSDD will finally have a safe and effective treatment. We are also validating that there’s a biological cause to this condition and that it’s not—as some have argued—in ‘women’s heads.’ It’s been a long time coming, but this approval is a welcomed and landmark breakthrough in women’s sexual health.

“Approval of this therapy is monumental for so many reasons: because it validates/legitimizes female sexuality as an important component of health; it underscores the FDA’s recognition of female sexual dysfunction as among the top 20 unmet medical needs; and it acknowledges that as a condition, HSDD is not simply a psychological problem or a reflection of cultural pressure on women, but a biological condition that can be treated with an effective medication.”

About the National Consumers League: The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

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ASHA Applauds FDA Approval of the First Drug to Treat Low Sexual Desire in Women

The American Sexual Health Association (ASHA) strongly supports the Food and Drug Administration’s (FDA) decision to empower women and their health care providers by approving flibanserin, the first drug to treat low sexual desire in females.

Hypoactive sexual desire disorder (HSDD, also known as low sexual desire) is the most commonly reported type of sexual dysfunction in women.1 Until today’s FDA decision there were no medical treatments available for the condition, leaving many women and medical professionals frustrated and puzzled at the lack of options. Speaking on the impact HSDD, Deborah Arrindell says “What I’ve heard from women is despair, anxiety, loss of confidence, loss of self worth, troubled relationships, and families in crisis. Women deserve to have desire, arousal, even pleasure. Clearly the FDA heard these women and today’s decision provides long overdue relief.”

That’s not to say that flibanserin is a proverbial magic pill. ASHA CEO Lynn Barclay believes it’s really about choices: “There is seldom a one-size-fits-all answer to the many challenges real people face in achieving and maintaining sexual health and satisfying sex lives. We believe BOTH men and women as well as their healthcare providers should have choices in addressing sexual dysfunction. We also believe that women – and men – can be trusted to decide for themselves about using an FDA-approved and health care provider-prescribed treatment option.”

Barclay adds that sexual health should not be seen as separate from our overall health, as each impacts the other. She says “This is about a woman’s well-being, her quality of life.” She notes that a woman’s sexual health affects her partner, too. “You’ve heard the saying ‘If mama ain’t happy, ain’t nobody happy’? Well, as grammatically imperfect as that may be, it makes a good point. Let’s make sure mamas, aunts, sisters, and women just like me everywhere have a complete menu of choices. We deserve it, we are worth it, and in the end we’ll all be better for it.”

The American Sexual Health Association (ASHA) is a not-for-profit organization founded in 1914 to improve the health of individuals, families, and communities, with a focus on educating about and preventing sexually transmitted infections. ASHA’s educational web sites include: www.ashasexualhealth.org, www.iwannaknow.org (teen site), and www.quierosaber.org (Spanish language site).

1. Kingsburg S, Rezaee R.. Hypoactive sexual desire in women. Menopause, 2013. 12: 1284-1300.

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Clinical Nurse Specialists: Approval of Flibanserin Represents Important Advance in Women’s Sexual Health

“The Food and Drug Administration’s approval of the first medication to help women suffering from sexual dysfunction represents an important advance in women’s sexual health. The FDA has approved 26 drugs to treat sexual dysfunction in men, but until now, none for women. That’s in spite of the fact than one in ten women suffers from hypoactive sexual desire disorder.

From Peggy Barksdale, MSN, RN, OCNS-C, CNS-BC is the President of the 2015-2016 NACNS Board of Directors:

“Now, women will finally have an option for treatment that they can discuss with their health care providers. We would hope that this will help increase the focus on developing ways to help women overcome sexual dysfunction and help end the gender inequality in this important area of health care.

“There has been a lot of concern about the side effects associated with flibanserin, and as an association representing advanced practice registered nurses, we take that seriously. We also know that the majority of FDA-approved drugs have side effects. It is important that women are educated about the side effects associated with this drug and then make their own decisions, in consultation with their health care providers, about whether to use flibanserin.”

Founded in 1995, The National Association of Clinical Nurse Specialists is the only association representing the clinical nurse specialist (CNS). CNSs are advanced practice registered nurses who work in a variety of specialties to ensure high-quality, evidence-based, patient-centered care. As leaders in health care settings, CNSs provide direct patient care and lead initiatives to improve care and clinical outcomes, and reduce costs. NACNS is dedicated to advancing CNS practice and education, removing certification and regulatory barriers, and assuring the public access to quality CNS services.

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WREI: The FDA Made History Today for Women

The Food and Drug Administration (FDA) made history today. They approved the first medical treatment for women’s sexual dysfunction, a breakthrough moment for women that comes 17 years after Viagra was brought to the market for men.

Women’s Research and Education Institute President Susan Scanlan celebrated this victory for the 1-in-10 American women who are suffering the distress of Hypoactive Sexual Desire Disorder (HSDD):

“As Chair of Even the Score, a campaign of patients, medical practitioners, and women’s policy and health advocates, I want to thank the FDA for this momentous decision. It recognizes women as sexual beings with a right to sexual fulfillment. It also enables women to make their own informed health decisions — in conjunction with their health care providers— to seek relief for a condition that’s been medically recognized for more than 30 years but until now has not had a single FDA-approved medical treatment. I want the FDA to know that millions of American women and their families and supporters are standing beside them as they write a new chapter in the story of gender fairness in sexual health.”

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MiddleSexMD: Celebrating the First FDA-Approved Treatment for HSDD

“The FDA’s announcement today that they’ve approved flibanserin is huge for women. This is the first medication approved for treatment of hypoactive sexual desire disorder (HSDD), also called female sexual dysfunction (FSD) and, more recently, female sexual interest/arousal disorder (FSIAD—a new abbreviation!).

“The multiple names for the condition we’re treating tell a story all by themselves. It’s been a long road to get sexual arousal issues for women the same attention as has been paid to erectile dysfunction in men, perhaps because the symptoms are less visible. The media coverage of the process, I’m hopeful, has had some educational effect, endorsing FSIAD as a real medical condition with real potential for treatments. I have new reason to be optimistic that this decision will lead to further developments in the field—because it’s been proven that it is possible to get a medical treatment in this arena through the FDA approval process.

“This approval is great news for women who suffer from this specific medical diagnosis, for whom I, as a menopause care specialist, have had nothing to offer. It’s great news for their partners, who, along with the women, have some hope and optimism that the desire and passion they once shared may be restored to their relationships. I’ve heard from women in my practice about the double-whammy of their loss of desire: Not only do they miss their sexual selves, they regret the unintentional messages they’ve sent their partners.

“I’m hopeful that hearing about this development will encourage more women to be frank with their health care providers. At least half of women will have sexual difficulty at some point, but far fewer of them will bring it up to their doctors. If they know there’s a possible treatment, perhaps women will have more motivation to ask. I haven’t seen a study, but I’d be willing to bet that more men asked doctors about erectile dysfunction when they’d heard Viagra was available.

“Together with my patients facing the FSIAD diagnosis, I can have a conversation about the potential benefits and side effects of this medication. We can make a plan of action. The women I serve aren’t expecting miracles; any possibility of even a modest improvement will be life-changing for them.

“As a doctor, I’ll now have something to say after ‘no, it’s not all in your head’ and ‘I’m sorry.’ I can’t wait.”— Dr. Barb DePree, MD, Founder of MiddlesexMD.

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SWHR Supports FDA Decision to Approve Female Sexual Dysfunction Treatment

The Society for Women’s Health Research (SWHR®) applauds the Food and Drug Administration (FDA) on the approval of flibanserin, the first ever medical treatment option for Hypoactive Sexual Desire Disorder (HSDD). Known as the most common type of female sexual dysfunction, HSDD affects one in ten American women each year.

Sexual health is an important component to a healthy life. For many years, it was a taboo topic and even today, many women are still hesitant to discuss their sexual health with their healthcare providers. Last year, SWHR, along with a number of patients and women’s groups, addressed the need for FDA-approved treatments for female sexual dysfunction. At that meeting, the FDA heard directly from patients on how HSDD, along with other types of female sexual dysfunction negatively impacts their health and well-being. Many patients spoke candidly about their use of products off-label to try to treat their condition and with their frustration about the lack of options available to them.

“The Society for Women’s Health Research is pleased that the FDA has approved the first ever treatment for HSDD, a type of female sexual dysfunction. This condition can severely impact a woman’s quality of life,” said Phyllis Greenberger, MSW, SWHR President and CEO. “We believe this is a good first step in addressing this need and hopefully this approval will generate more research into HSDD and further treatment options for women.”

SWHR applauds the FDA on its leadership in treating HSDD with the same priority as other sexually related disorders. This is an important step toward health equity and will have a positive impact on the lives of millions of women and men.

To learn more about SWHR, the thought leader in transforming women’s health research, visit www.swhr.org.

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HealthyWomen: FDA Approval of Flibanserin will have historic repercussions

The FDA’s approval of flibanserin will have historic repercussions. First, for 1-in-10 women who are living with HSDD without a single approved medical treatment for their condition. And second, it will mean the difference between opening a pipeline of future of options for women’s sexual health and closing it for good. Today, Women deserve the safety and peace of mind that comes with access to FDA-approved medical treatment options for their HSDD.

That’s why HealthyWomen.org, the nation’s leading women’s health online resource, became a member of Even the Score. As the representative of 5 million actively engaged American women who visit our website, we want to be clear – we’re not advocating for approval of a particular drug. But as the first HSDD medical treatment option in a pipeline that must be opened, we are pleased that the FDA gave flibanserin fair consideration.”

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Women’s Health Foundation: FDA has chosen to act for women

“This drug gives women the ability to have healthy, active sex throughout their lives and we are very excited that the FDA has chosen to recognize the power and importance of today’s action.” – Missy Lavender, CEO, Women’s Health Foundation.

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CHANGE Applauds FDA for Listening to Women

The Food and Drug Administration (FDA) this week approved flibanserin, the first-ever medical treatment for hypoactive sexual desire disorder (HSDD) – the most common form of sexual dysfunction reported by women. The decision comes after more than a year of advocacy and outreach – including two public meetings at the FDA – from women who suffer from HSDD. In response to the FDA announcement, Serra Sippel, president of the Center for Health and Gender Equity (CHANGE), issued the following statement:

“Today we celebrate a victory for women’s sexual rights. To pursue a safe and satisfying sexual life is a human right and today marks the first time there is a medical treatment that women can choose, among other options, to address sexual dysfunction.

“Rarely do we have an opportunity to have a public conversation about sexual pleasure and the right to a fulfilling sex life. This year we celebrate the 20th anniversary of the Fourth World Conference on Women held in Beijing, China, where women’s rights advocates and national governments affirmed the rights of women and committed to gender equality. Sexual and reproductive rights – which include the right to satisfying sex – are the cornerstones to achieving gender equality and the empowerment of women and girls.

“While CHANGE does not advocate for one form of treatment over another, we do advocate for listening to women. This week’s FDA decision is about respecting a woman’s right to choose the best path forward in realizing her best sexual self.”

ABOUT CHANGE: The Center for Health and Gender Equity (CHANGE) is a U.S.-based women’s rights organization whose mission is to promote the sexual and reproductive health and human rights of women and girls globally by shaping the development and implementation of U.S. policies. We envision a world where sexual and reproductive health and rights are universally recognized, and where comprehensive, integrated sexual and reproductive health services are accessible and available to all, free from coercion, violence, and discrimination.

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The American College of Nurse-Midwives Commends FDA for Approval of a Drug for HSDD

The American College of Nurse-Midwives (ACNM) is the professional association representing certified nurse-midwives (CNMs®) and certified midwives (CMs®) in the United States. We are committed to upholding the most rigorous clinical practice standards in the midwifery profession.

“ACNM commends the FDA for its approval of a drug for Hypoactive Sexual Desire Disorder (HSDD). As primary care providers and a major stakeholder in the provision of care for woman throughout the life cycle, ACNM knows that 1 in 10 women suffer from HSDD and that it is a complex problem. The FDA has a long history of approving drugs that have the potential to have meaningful benefits for patients, with the understanding that patients will weigh the risks versus the benefits of a possible medical treatment in consultation with their healthcare provider.

Approval of flibanserin, the first drug to treat women’s most common sexual dysfunction, represents a huge step towards helping women with HSDD. Treatment for HSDD can have a substantial impact on an affected woman’s overall health and well-being. On behalf of all the women served by midwives, thank you for your approval of this treatment option.”

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