WASHINGTON — The Food and Drug Administration on Thursday will once again weigh whether flibanserin, the "Viagra for women," should be approved for sale and use in the U.S.
Flibanserin has been rejected twice by the FDA on grounds that it offers some effectiveness but that it is outweighed by side effects such as sleepiness, dizziness and nausea that could cause problems for women operating machinery or even driving.
Sprout Pharmaceuticals, which owns the drug, has submitted new data, including a study to demonstrate that the pill does not impair women’s abilities during daily life.
The Even the Score campaign, backed by the Sprout Pharmaceuticals and some women’s groups such as the National Council of Women’s Organizations, the Black Women’s Health Imperative and Jewish Women International, has accused the FDA of gender bias for approving Viagra and 25 other drugs to help men stay erect, while no such drugs improving sex lives were given the green light for women.
“A biological lack of desire to have sex negatively impacts the lives and relationships of 1-in-10 American women,” an Even the Score petition reads. “Its official name is hypoactive sexual desire disorder — and it is women’s most common sexual complaint.
"But unfortunately, the millions of women living with this disorder don’t have a single FDA-approved treatment option for HSDD. And that’s while men have 26 FDA-approved treatments marketed for male sexual dysfunction. You read that correctly: 26.”
