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'Women's viagra': FDA panel hears testimony as advocates push for pill 'Women's viagra': FDA panel hears testimony as advocates push for pill
(35 minutes later)
Women testified about their fears of never being able to have sex again at a Food and Drug Administration (FDA) hearing in Washington on Thursday, in an effort to push the agency to approve a drug that is touted as “women’s viagra”.Women testified about their fears of never being able to have sex again at a Food and Drug Administration (FDA) hearing in Washington on Thursday, in an effort to push the agency to approve a drug that is touted as “women’s viagra”.
A coalition of women’s groups and the drug’s manufacturer are advocating for approval of the pill, Flibanserin. Other women’s health advocates are advising that the agency remain cautious.A coalition of women’s groups and the drug’s manufacturer are advocating for approval of the pill, Flibanserin. Other women’s health advocates are advising that the agency remain cautious.
“I should be able to determine if Flibanserin is worth the benefit of treatment,” said Amanda Parrish, one of more than 11,000 women who participated in a clinical trial of the pill.“I should be able to determine if Flibanserin is worth the benefit of treatment,” said Amanda Parrish, one of more than 11,000 women who participated in a clinical trial of the pill.
Parrish said she began experiencing low libido during her second marriage and therefore decided to participate in the clinical trial.Parrish said she began experiencing low libido during her second marriage and therefore decided to participate in the clinical trial.
“What a relationship-saving eight months that was,” she said.“What a relationship-saving eight months that was,” she said.
Flibanserin does not work in the same way as Viagra, which increases blood flow, a simple biological function. Flibanserin, which was first studied as an antidepressant, changes brain chemistry.Flibanserin does not work in the same way as Viagra, which increases blood flow, a simple biological function. Flibanserin, which was first studied as an antidepressant, changes brain chemistry.
For that and other reasons, a coalition led by the National Women’s Health Network opposes approval of the drug.For that and other reasons, a coalition led by the National Women’s Health Network opposes approval of the drug.
“The problem with Flibanserin is not gender bias at the FDA but the drug itself,” the group said in a letter to the FDA.“The problem with Flibanserin is not gender bias at the FDA but the drug itself,” the group said in a letter to the FDA.
In 2010, Flibanserin was rejected unanimously by an FDA panel, which said its benefits did not outweigh its risks, which can include low blood pressure and fainting spells.In 2010, Flibanserin was rejected unanimously by an FDA panel, which said its benefits did not outweigh its risks, which can include low blood pressure and fainting spells.
Sprout pharmaceutical company picked up the drug in 2011 after it was dropped by its initial developer, Boehringer Ingelheim. They submitted it to the FDA again, and in October 2013 it was rejected again.Sprout pharmaceutical company picked up the drug in 2011 after it was dropped by its initial developer, Boehringer Ingelheim. They submitted it to the FDA again, and in October 2013 it was rejected again.
“The fundamental question is whether these observed placebo-corrected treatment effects outweigh the risks associated with treatment,” the FDA said in its latest review.“The fundamental question is whether these observed placebo-corrected treatment effects outweigh the risks associated with treatment,” the FDA said in its latest review.
In March, 11 members of Congress wrote to the FDA in support of a new review of the drug. The FDA is expected to decide on whether to approve the drug in August.In March, 11 members of Congress wrote to the FDA in support of a new review of the drug. The FDA is expected to decide on whether to approve the drug in August.
A coalition of women’s groups, as well as Sprout, started a campaign called Even the Score, which believes there is a disparity in how sexual dysfunction drugs are made available.
Last year, Anita Clayton, interim chair of the Department of Psychiatry and Neurobehavioral Sciences at the University of Virginia wrote in support of the drug for The Huffington Post and said that the FDA need to “overcome the problem of institutionalized sexism.”
Susan Wood, a former FDA assistant commissioner for women’s health, said that accusing the agency of sexism “is wildly off the mark.”
She resigned in 2005 when the government refused to make Plan B available over the counter and is now an associate professor at George Washington University.
“FDA’s responsibility is a broad public health one and it is to weigh the risks and benefits against each other for any particular product,” said Wood. “And I don’t think they are doing it any differently here than they do any other product.”