FDA hits back at charge of gender bias in libido drug decision

By Toni Clarke WASHINGTON (Reuters) – The U.S. Food and Drug Administration hit back on Tuesday at critics who have charged it with gender bias for rejecting a drug for low female libido from Sprout Pharmaceuticals. Women’s groups, who have lobbied heavily for the drug’s approval, pounced after the FDA denied an appeal to approve the product, a once-a-day treatment for hypoactive sexual desire disorder (HSDD), accusing the agency of bias. “When it comes to approving drugs for male sexual dysfunction, the FDA says yes with more limited research and serious side effects, but when it comes to women, their go-slow tactics are preventing us from having access to a treatment option where we make the decision in consultation with our healthcare provider,” said Terry O’Neill, president of the National Organization for Women, in a statement. The FDA rejected the charge, saying in an email that it “engaged in a scientific process in which we evaluated whether the drug’s benefits outweigh its risk.” The FDA declined to approve the drug, flibanserin, last year saying its effects were “modest” and did not outweigh side effects such as dizziness, nausea and fatigue.