Why has FDA Approved 26 Sex Improvement Drugs for Men, but None for Women?

Friday, June 06, 2014

No matter the playing field, a score of 26-0 is ridiculously lopsided. That’s why a coalition of women’s organizations has complained about the Food and Drug Administration’s (FDA) scorecard for approving sexual-dysfunction treatments: 26 for men, zero for women.


“We have waited long enough. It’s time for the FDA to act for women by approving the first-ever drug to treat the most common form of women’s sexual dysfunction and open the field of research for a variety of treatment options to come,” Susan Scanlan, chair emerita of the National Council of Women’s Organizations (NCWO), said in a statement. The coalition represents 12 million women belonging to 240 progressive women’s groups.


Under the campaign “Even the Score,” NCWO intends to lobby the FDA to approve the first treatment for hypoactive sexual desire disorder (HSDD), a condition impacting women with weak libido. One in 10 women suffers from HSDD, according to the International Journal of Women’s Health.


The disorder involves more than a reduced sex drive, gynecologist Dr. Lauren Streicher told Good Morning, America (GMA). “[It] is a very specific problem in a woman who doesn’t think about sex, she doesn’t fantasize, she doesn’t desire sex,” she said. “What makes it different is that it’s distressing to her. This has a negative impact on her. She’s worried about it, she’s frustrated.”


Sprout Pharmaceuticals, based in North Carolina, has developed the drug Flibanserin (known as the “little pink pill”) to help those with HSDD. Unlike Viagra, which treats male sexual dysfunction by addressing blood flow, Sprout’s drug alters chemicals in women’s brains to help them achieve sexual desire. But it has yet to get FDA’s approval to market the treatment after three years of trying. Its rejection by the agency triggered a storm of protest from women’s advocacy organizations. “There’s absolutely some sexism at play,” said Streicher of the FDA roadblock.


Some doctors disagree, saying the agency rejected the drug because it’s a cure for a non-existent disease. “It’s not sexist for the FDA not to approve a drug that it doesn’t believe is effective or safe,” Dr. Adriane Fugh-Berman told GMA. “Of course sexual desire varies by person and it varies by phase of life, but that doesn’t make it a disease.”


Last month, Sprout’s founder and COO, Cindy Whitehead, complained there were “25 approved drugs for some form of male sexual dysfunction, but still a great big zero for the most common form of FSD [female sexual dysfunction]. No matter how or why we got here, we're here, and we've got to come up with a solution for it.”


One week after Whitehead’s interview with ABC News, the FDA okayed yet another drug for men’s sexual problems, making it 26 to nothing. The latest male-oriented sexual treatment to receive FDA’s support is Natesto™, the first nasal gel to help men with low testosterone. Manufactured by Trimel Pharmaceuticals Corporation, the drug joins a list of 31 other products sanctioned by the FDA that address testosterone.


The launch of the NCWO’s campaign comes on the heels of a letter that was sent to the FDA by four female Democrats of the U.S. Congress—Reps. Debbie Wasserman Schultz (Florida), Chellie Pingree (Maine), Nita Lowey (New York) and Louise Slaughter (New York)—that requested the agency address the “gross disparity between treatments for men and women” by approving a drug to treat female sexual dysfunction.

-Noel Brinkerhoff, Danny Biederman


To Learn More:

Women's Groups Launch Campaign to 'Even the Score' on FDA-Approved Treatments for Women's Sexual Dysfunction, Provide Voice for the 1-in-10 Women who Experience HSDD (Even the Score)

Fight Over 'Little Pink Pill' Raises Sexism Questions (by Mara Schiavocamp, Jackie Jesko and Lauren Effron, ABC News)

Trimel Receives FDA Approval for Natesto(TM) Nasal Gel to Treat Men with Low Testosterone (Trimel Pharmaceuticals)


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