Bioethics Blogs

The FDA, Finances, & Feminism: Why the third time was the charm for so-called “female Viagra”

By: Elizabeth Yuko, Ph.D.

Money can’t buy happiness, but evidently is instrumental in gaining FDA approval for controversial drugs with low efficacy and significant side effects.

On Tuesday, the U.S. Food and Drug Administration (FDA) approved Addyi (Flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, after denying approval in 2010 and 2013 because the risks of the medication did not outweigh the benefits.

The side effects, which include dizziness, sleepiness, nausea, fatigue, insomnia and dry mouth, are not only more prominent than the low levels of efficacy reported in the clinical trials, but are also exacerbated by the consumption of alcohol to such an extent that the FDA granted approval only with a risk evaluation and mitigation strategy (REMS) and a Boxed Warning – the strongest kind.

Why did the FDA decide to approve Addyi this time? The drug did not become any safer or more beneficial; the difference came from a lobbying group largely funded by the pharmaceutical company behind Addyi called Even the Score. Coopting feminism to sell pills under the guise of equality, Even the Score casts Addyi as one small step towards sexual equity, finally giving women a means to medicate what society has deemed to be a low sex drive.

What exactly is Addyi treating? The FDA specifies that HSDD is “characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.