A Pink pill or female Viagra failed to meet the safety and efficacy requirement of FDA and therefore, was rejected by the Health panel after extensive discussion this week. However, the drug, flibanserin got approved in the Europe last year.
According to the FDA the drug failed to demonstrate a “statistically significant improvement” in sexual desire in two clinical trials. Also the treatment doesn’t provide enough benefits to outweigh potential risks to women such as fatigue, depression and fainting spells.
In response of the FDA’s decision, Michael Sand, Boehringer’s director of general medicine told the panel “totality of evidence” from research in the U.S. and Europe shows that flibanserin provides “clinically meaningful, statistically significant improvements” in Hypoactive Sexual Desire Disorder (HSDD) symptoms.
The FDA may use a “very high safety threshold” in deciding whether to approve flibanserin because low sexual desire isn’t a life-threatening condition. On the contrary Boehringer has been marketing flibanserin by trying to persuade...
regulators and consumers that low sexual desire is a disease.
FDA has tightened its belt in recent years, partly due to the new leader heading FDA and partly due to the fact that FDA has been criticized for going easy on pharmaceutical and medical device companies. I do think that low sexual desire may not be life threatening but certainly could affect moral of a person. In my view further research is needed to evaluate the safety and efficacy of the drug in HSDD and women are waiting for their own version of Viagra.