FDA to rule on female ‘Viagra’

However, that is what is happening as the Food and Drug Administration is set to decide Tuesday whether to approve a female libido drug called flibanserin.

The decision could be the most controversial this year for the agency, which must weigh safety concerns against a coordinated campaign that says the FDA has discriminated against women.

The coalition Even the Score has heavily campaigned for the FDA to approve the drug, saying that it addresses a gender disparity.

The group says 26 drugs have been approved to treat various sexual dysfunctions in men, and more than 40 if you count generics, but none for women.

“The FDA has recognized female sexual dysfunction as one of its 20 priority areas of unmet medical need yet women still wait for a single safe and effective FDA-approved treatment option,” the group said on its website.

The agency has said that sexual complaints among women such as lacking interest or inability to achieve climax are reported by 43 percent of women ages 18-59, citing a 1995 study.

Members of Congress have weighed in on the controversy. A letter from 11 House members in March called on the FDA to approve the treatment.

“We firmly believe that equitable access to healthcare should be a fundamental right, regardless of whether you are a man or a woman,” reads the letter led by Rep. Jackie Speier, D-Calif. “But when it comes to sexual health — and, in particular, sexual dysfunction — that is not the case.”

While this isn’t the first product to be supported by a consumer advocacy group, the claims of gender discrimination over sexual dysfunction drugs are noteworthy, according to a July article written by three agency advisers who reviewed flibanserin.

The advisers wrote in the Journal of the American Medical Association. The entire advisory board voted 18-6 in June to recommend approval, but wanted additional protections for patients due to safety concerns.

Critics have said the Even the Score campaign is disingenuous since it is supported partly by Sprout Pharmaceuticals, the drug’s manufacturer.

“Even the Score is not a grassroots feminist movement: It is an industry-funded social media campaign to promote flibanserin,” according to a fact sheet from PharmedOut, a Georgetown University Medical Center project that takes aim at pharmaceutical marketing practices.

Sprout did not disclose how much it has given the campaign, but it told the Washington Examiner that 26 other groups and industry organizations support it. The campaign is supported by women’s groups such as the National Organization for Women, the Women’s Health Foundation and the drug-maker Trimel Pharmaceuticals.

PharmedOut wrote to the FDA that the drug is only minimally effective and largely unsafe.

“The harms and narrow margin of safety of flibanserin might be acceptable in a cancer drug, but are entirely unacceptable in a drug given to healthy women for a questionable condition,” the group wrote. “Low libido can be effectively treated by therapy.”

Even the Score did not return requests for comment.

A qualm from the three advisers — Walid F. Gellad, Kathryn Flynn and G. Caleb Alexander — and PharmedOut are persistent safety issues, such as problems driving the next day and the combination of the medication and alcohol.

Drug maker Boehringer Ingelheim originally developed flibanserin to be an antidepressant. Then one of the trials showed that female sexual desire increased while on the drug.

While compared to the popular male erectile dysfunction drug Viagra, flibanserin is different since flibanserin must be taken every day while Viagra only before sex.

Sprout acquired the drug and has twice tried unsuccessfully to get it approved, with a major sticking point being safety.

The agency rejected it in 2010 and 2013, with the latest rejection in response to concerns over low blood pressure risks and the potential for adverse effects while consuming alcohol.

When Sprout reapplied for approval, it offered new safety studies that suggest the drug doesn’t impair driving the next day and favorably compares its side effects to other products. One of the new studies confirmed the side effects of alcohol while taking the drug, the advisers wrote.

“Although the driving study was reassuring, isolated comparisons of safety across products can be misleading because FDA product reviews are not fundamentally comparative in nature,” the advisers added.

The alcohol study was also troubling as it took a sample of 25 healthy people, only two of whom were women, the article said.

Under federal law, the agency has until Tuesday to approve or reject the drug. The FDA does not have to adopt the recommendations of its advisers, but it usually does.

Sprout told the Examiner that if the drug, going by the brand name Addyi, is denied again, it plans to focus on obtaining approval in Europe.