Stephan Rosger Social groups are pushing the US Food and Drug Administration, or FDA to review and finally approve a drug called Flibanserin, or more popularly known, as "Women's Viagra." The advisory committee of the agency is set to have a meeting on June 4, 2015, Thursday to discuss if the said drug, which is said to resolve decreased sexual desires in women, should be made available to the public.
FDA first rejected Flibanserin in 2010 on the grounds that the drug may cause more side effects than therapeutic benefits. The side effects identified nausea, dizziness and sleepiness. The drug, which was originally owned by Boehringer, was later acquired by Sprout Pharmaceuticals, who submitted another set of data to the FDA for review. The agency disapproved the drug once again in October 2013, due to the similar reasons they identified during the drug's first rejection. Sprout pharmaceuticals passed another appeal to the FDA, which now includes evidence that the drug does not affect driving. Flibanserin will be officially labelled as treatment for hypoactive sexual desire disorder if the FDA approves the drug. The said medical disorder is characterized by low libido in women.
Several social groups think that women are not given equal resources to address their sexual problems, as much as men. They argue that Flibanserin is crucial in determining the extent of gender equality present. Among the groups advocating the drug are Even the Score, the Black Women's Health Imperative, National Council of Women's Organizations and Jewish Women International. Medical organizations such as Association of Reproductive Health Professionals also expressed support.
Even the Score made a petition to help Flibanserin get official approval from the FDA. The group was able to collate about 40,000 signatures. "There are 26 FDA approved drugs to treat various sexual dysfunctions for men [41 if you count generics!], but still not a single one for women's most common sexual complaint," the Even the Score petition iterates. "Why do we fast track the approval of drugs like Viagra [1998] for men? ...Sex is a basic human right. If individuals have a medical condition that affects their sexual function, men or women, we believe they deserve access to medical treatment options and the opportunity to make a choice with their healthcare provider on whether or not that treatment is right for them."
The FDA strongly disagrees on the claims pertaining to gender bias surrounding the issue. A spokeswoman backs this by stating that the agency conducted a two-day drug development workshop for the public in 2012. The said initiative is a proof that the FDA prioritizes female sexual dysfunction, she adds.
Photo: Stephan Rosger | Flickr
