After a two-year wait, the US Food and Drug Administration finally issued new guidance for companies that want to develop drugs to bolster female libidos. But the details suggest the agency has belatedly learned some hard-fought lessons following complaints that the controversial Addyi pill did not warrant approval last year.
The 15-page draft guidance, which was released Tuesday, offers a typical how-to for companies, but also points to certain steps that Sprout Pharmaceuticals did not follow as part of its Addyi marketing application to the FDA. The drug, which is now sold by Valeant Pharmaceuticals, was approved despite debate over its safety and effectiveness, and the extent to which medicines should be used to treat female sexual dysfunction.
It “looks like the FDA is using this guidance to keep another company from trying to get a female sexual desire drug approved based on unreliable data collection instruments and weak results,” said Cindy Pearson, executive director of the National Women’s Health Network, who opposed the approval. “Unfortunately, the FDA is locking the barn door after the horse got out. So now, the agency is telling other companies to do some things that Sprout didn’t do.”
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and networking platform access.
Already have an account? Log in
Already have an account? Log in
About the Author Reprints
To submit a correction request, please visit our Contact Us page.
STAT encourages you to share your voice. We welcome your commentary, criticism, and expertise on our subscriber-only platform, STAT+ Connect