Hell hath no fury like the Food and Drug Administration scorned?

Sprout Pharmaceuticals scored a major victory Thursday in its battle with the FDA to win approval for a so-called “female Viagra” when a review committee voted 18-6 in support of the drug known as flibanserin.

But will it be a Pyrrhic one?

The company, led by Chief Executive Cindy Whitehead, has noted that the FDA almost never goes against a recommendation made by such a group when it decides whether to formally approve a drug.

Yet the FDA is angry – very angry.

In arousing support for flibanserin with an aggressive “Even the Score” campaign that noted the many choices of drugs for men to treat sexual desire disorders versus none for women, Sprout upset the FDA.

“Currently, men have access to 26 FDA-approved medical treatment options for sexual dysfunction – while women have zero biological treatment options for their most common complaint, Hypoactive Sexual Desire Disorder (HSDD), despite the fact that it affects 1-in-10 American couples,” the group said.

How will the drug agency respond when a final decision is made in August?

Rebuking gender bias claim

In documents submitted before the committee hearing Thursday in Washington, D.C., and again during the proceedings, the FDA made quite clear its anger.

Here’s how the FDA vented in print:

“Publicity and Claims of Gender Bias:

“Panel members may be aware of the extensive publicity surrounding flibanserin and treatments for female sexual dysfunction. Some have alleged that there is gender bias at the FDA, stating that there are many medications approved for treating male sexual dysfunction but none for treating female sexual dysfunction, and that the FDA is holding drugs intended to treat female sexual dysfunction to more stringent standards of approval. These claims are misleading and inaccurate. The FDA rejects claims of gender bias. The FDA’s regulatory decision for each product is based on an assessment of whether the benefits outweigh the risks and does not take gender into consideration. The flibanserin NDA raises challenging scientific issues.

“The FDA welcomes science-based recommendations from the Advisory Committee panel as to whether the available data support a positive benefit/risk assessment for flibanserin.”

Sprout funneled financial support to the “Even the Score” campaign. Congress weighed in, too.

“The call for gender equity in the approval of treatments for sexual dysfunction has grown louder, with some of the nation’s most prestigious women’s health and other research groups voicing serious concerns about this disparity,” read one letter.

Democratic 4th District Congressman David Price also chimed in, writing, “It is vital that we equalize the standard of care is this area.”

Yet, there are no guarantees the FDA will go along.

Whitehead: ‘One step closer’

Sprout is hopeful.

“We are pleased with the positive outcome of today’s Advisory Committee meeting and the confidence that was expressed regarding the efficacy and safety of ADDYI [the brand name],” Whitehead said in a statement provided to WRAL TechWire and WRAL.com after the vote Thursday.

“With today’s decision, we are one step closer to bringing to market the first treatment option for the most common form of female sexual dysfunction. We look forward to continuing our work with the FDA as it completes its review of our new drug application, including the discussion of a Risks Evaluation and Mitigation Strategy (REMS).”

Yet, not everyone was pleased with the victory.

“It’s exciting we’ll have this in our armorarium… but we all wish it was a better drug,” panel member Amy Whitaker, an assistant professor in the Department of Obstetrics and Gynecology at the University of Chicago, was quoted as saying by The Wall Street Journal.

Then there is this comment from the same WSJ story from Cindy Pearson,executive director of the National Women’s Health Network:

“As a feminist, I’m delighted people are taking women’s sexual issues seriously, but recommending approval for this drug isn’t the correct response. This sets a low bar.”

The Los Angeles Times, in an editorial published before the vote, stated quite strongly that gender issues had no business playing a role in a drug approval decision. “Fate of ‘pink Viagra’ should be determined by science, not politics,” the paper said.

Now it’s up to the FDA.