FDA approves "pink Viagra" for women

Michael Cook
23 Aug 2015
Reproduced with Permission

Nearly 20 years after approving Viagra, the US Food and Drug Administration has approved a drug for enhancing female libido. Approval was announced on Tuesday and on Thursday Sprout Pharmaceuticals, the small company which had ushered it through the regulatory process, was sold for US$1 billion in cash to Valeant Pharmaceuticals International, the largest public company in Canada.

The drug, Addyi, also known as flibanserin, works on the brain, somewhat like an anti-depressant. Sprout bought it from a German company which had given up after the FDA rejected an application in 2010. Its prospects for approval were not great, because it was only modestly effective in heightening libido, but at the cost of side effects like dizziness, nausea and fainting. It is not supposed to be taken on conjunction with alcohol.

The next step for the new owners is to get health insurers to pay for the drug, since most already cover Viagra. Valeant will face some resistance, as critics say that Addyi is a lifestyle drug, not a treatment for a medical condition. However, Sprout already developed a response to this. It promoted its product vigorously as a cure for "hypoactive sexual desire disorder" (HSDD). Through a group called " Even the Score ", it argued that satisfying sex was a fundamental human right. If men had Viagra, women needed their own drug. It recruited the National Organization of Women to burnish the drug's feminist credentials.

The pressure was too much for the FDA. Its committee approved the drug by a vote of 18 to 6, but none on the panel was willing to endorse it without caveats.

Some critics suspect that HSDD is not a real disorder, but a bubble of hype created by drug companies. The real problem may be one of relationships. As British sexologist Petra Boynton, told The Guardian : "The cultural wallpaper is telling you that to keep someone and be desirable and not left alone, which is a huge fear, you must be having and providing frequent sex."

Addyi is the first approved drug for HSDD (which used to be called female sexual dysfunction and female sexual arousal disorder). But soon after Viagra was approved in 1998, many attempts were made to get a similar product for women approved. So many, that one critic wrote in PLoS Medicine :

The creation and promotion of "female sexual dysfunction" (FSD) is a textbook case of disease mongering by the pharmaceutical industry and by other agents of medicalization, such as health and science journalists, healthcare professionals, public relations and advertising firms, contract research organizations, and others in the "medicalization industry."

Other critics warn that Addyi's approval sends a dangerous message. "To approve this drug [sets] the worst kind of precedent - that companies that spend enough money can force the FDA to approve useless or dangerous drugs," Dr Adriane Fugh-Berman , of Georgetown University, told the FDA in June.