Washington, D.C. – The National Women’s Health Network (the Network) is profoundly disappointed with the U.S. Food and Drug Administration’s (FDA) decision to approve flibanserin, a proposed treatment for female sexual dysfunction, despite inadequate proof of effectiveness and questionable assurances of the drug’s safety. The FDA’s recommendation for approval - conditioned with significant risk mitigation strategies - comes after the agency rejected this controversial drug twice before.
The Network believes that the FDA’s approval of flibanserin, which was influenced by an unprecedented and coercive sponsor-initiated marketing and public relations campaign, errodes the integrity and meaningfulness of the FDA’s own standard for approving drugs.
In 2010, following a review of the original new drug application submitted by pharmaceutical company Boehringer-Ingelheim, the FDA advisory panel voted unanimously against approval of flibanserin given the concerning risk-benefit analysis. The FDA listened to the advisory panel’s concerns and rejected flibanserin’s application. Flibanserin was submitted for approval again in 2013, this time by Sprout Pharmaceuticals, and was once again rejected because of the sponsor’s inability to provide evidence of both safety and efficacy. The Network publicly applauded the FDA for both previous decisions and for upholding the stringent drug review process that protects women and consumers.
Flibanserin’s advisory committee meeting earlier this year revealed troubling reports of serious adverse events, a strong placebo effect, and higher dropout rates in the flibanserin arm of all three pivotal trials. The FDA’s own internal investigation demonstrated many unresolved questions about the seriousness, severity, duration, and frequency of flibanserin’s side effects. The extent of these effects, when used concurrently with alcohol, birth control pills, and a host of other drugs, are less known and even more risky and concerning for women. Furthermore, the early animal clinical data demonstrated a potential increased risk of breast cancer, a finding that was largely dismissed by the sponsor.
The FDA also recommended that Sprout Pharmaceuticals provide evidence of flibanserin’s safety, specifically its interaction with alcohol and effect on driving ability. Inexplicably, in their 25-person alcohol study, Sprout included only two women. Many advisory panel members, women’s health organizations, and individuals expressed deep concern that Sprout’s alcohol study was insufficient to understand the effect of this drug in women who use alcohol, and recommended against approval a third time this past June. Disappointingly, instead of insisting that this study be performed and evaluated prior to approval, the FDA is requiring Sprout to conduct post-approval trials. This is a weak and inadequate measure, as historically, a substantial proportion of post-approval trials are never completed, despite being a condition of approval.
In the absence of this crucial information, the FDA is counting on women to abstain from alcohol while using flibanserin, in spite of the fact that there is no known intervention or REMS that can ensure people abstain from alcohol in the long term when consumption significantly increases serious risks from other medications.
The Network recognizes that a lack of sexual desire can be a distressing problem for women. We also believe that it might be possible in the future to develop a drug that is effective for some of women’s sexual problems. However, women must be able to rely on the FDA to ensure that any drugs or devices marketed to and used by them are both safe and effective. Flibanserin’s approval today sets a dangerous precedent that a clever public relations campaign can sway the FDA’s evidence-based, decision-making process.
Despite the FDA’s approval, we still have serious doubts about whether women are able to make informed decisions about the safety and effectiveness of this controversial drug. We will continue to monitor flibanserin and work to ensure that women are able to make informed decisions about treatments for sexual problems.
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.
Christina Cherel, MPH, is a women’s health advocate and former NWHN Policy & Advocacy Manager. Currently, she advocates globally for reproductive health research as Program Officer for the Bill & Melinda Gates Institute and as Communications Chair for the International Conference on Family Planning.