The NWHN’s Statement on the FDA’s Approval of Vyleesi

The following statement can be attributed to Cynthia A. Pearson, Executive Director of the National Women’s Health Network.

Washington D.C. -- The National Women’s Health Network (the NWHN) is disappointed in the United States Food and Drug Administration’s (FDA) decision to approve the drug bremelanotide (brand name: Vyleesi) and urges women to avoid using the drug until more is known about its safety and effectiveness.   

Women simply do not have enough information to make an informed decision about whether the drug is safe and effective. The FDA did not call on their advisers to review the drug publicly, and the sponsor has not yet published full clinical trial results. The limited data that has been published leaves many important questions unanswered. For example, it appears that hundreds of women enrolled in the pivotal trials were not included in the company’s presentation of the results.  What happened to those women?

Public disclosure and discussion of the underlying safety and effectiveness data is especially important for a drug intended to treat a sexual desire disorder.  Unfortunately, women cannot trust the FDA to say no to a female desire disorder drug that does not meet the legal standards of safety and effectiveness. The FDA approved flibanserin, the first desire disorder drug, because of an effective lobbying campaign, not because of convincing data. Did that happen again?  

AMAG Pharmaceuticals, US sponsor of bremelanotide, is already using misleading tactics in its marketing.  Earlier this year, AMAG launched the “unblush” website and social media campaign. “Unblush” tells women to “transform frustration to strength” while promoting a scientifically unsound screening test that seems designed to give women the message that they have a problem that needs fixing by medicine.  It is offensive to see a drug company use the language of the women’s rights movement to sell a product that could be useless at best and harmful at worst.

Bremelanotide needs more scrutiny. Women need more information. The FDA had it in its power to do both.  We’re frustrated that the FDA has allowed this product on the market without providing women with the assurance they deserve that it is safe and effective. Women deserve better.

The National Women’s Health Network is supported by our members and by choice we do not accept financial support from drug companies or medical device manufacturers. We bring the voices, concerns, and needs of women consumers to policy and regulatory tables.

Cindy Pearson was the NWHN’s Executive Director from 1996 to 2021. One of the nation's leading advocates for women's health, Cindy often testified before Congress,  NIH and the FDA and was frequently featured in the news as a consumer expert on women’s health issues. When she retired, Cindy received a Congressional Resolution in honor of her outstanding contributions to the health of women and girls.

Read more from Cindy Pearson.