Public Relations or Science: Which Won FDA Approval for “Female Viagra?”

The FDA approves the little pink pill. But was the decision based on science or PR?

Female sexual dysfunction is real. So is the medical research bias toward conditions afflicting men. And so is the role that public relations played in the FDA’s approval of flibanserin, a drug meant to treat hypoactive sexual desire disorder.

Experts are divided regarding the drug’s efficacy—and safety, but the FDA is sold on both. Is it because the science behind flibanserin is sound or is it because of a relentless campaign by advocates to give women the same relief from sexual dysfunction that men have enjoyed for the past 18 years?

The physiology behind female sexual dysfunction is complicated. And women who have lost self-esteem and relationships because of it have been clamoring for years for better and more research to help them. If men could take a little blue pill, why couldn’t they take a little pink pill?

Enter Sprout Pharmaceuticals makers of ADDYI™ the little pink pill to the rescue. But the FDA twice rejected the drug over questions about safety and effectiveness.

At a hearing last June, there was testimony from the research community recommending against approval. But there was even more testimony from advocates of the drug, leveling charges that the FDA was being sexist in denying women access to ADDYI. More than 200 researchers, clinicians, and sex therapists urged the FDA to withhold approval, and to not succumb to the “gender justice” argument.

Leading the charge in support of ADDYI was an organization called Even the Score, whose goals are to: educate, inform, advocate, and support – in short “to level the playing field when it comes to the treatment of women’s sexual dysfunction.” Even the Score has the support of 19 non-profits such as the National Organization for Women, the National Consumers League, and the Society for Women’s Health Research.

It also has the financial support of Sprout Pharmaceuticals.

Some say the FDA shirked its duty and was cowed by a masterful PR campaign funded, in part, by the company that will profit from its sale. The FDA says new research presented by Sprout has satisfied its concerns and it is approving the drug with adequate warnings about side effects and all the necessary safeguards.

Whether it was science, PR, or a little of both that won the day, millions of women are pinning their hopes on ADDYI. And millions of dollars are about to start flowing into Sprout’s accounts.

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