Following on from my previous post about the misleadingly dubbed “pink Viagra”, the drug flibanserin, to treat low sexual desire in women, news was received today confirming approval of the drug by the Food and Drug Administration. The approval follows the recommendation of an advisory committee convened to assess the safety and efficacy of the drug. After a day of hearings on 4 June the advisory committee agreed to recommend approval but did so reluctantly, and with a number of concerns about the management of the potential risks.

Three members of the scientific advisory committee subsequently published a viewpoint article in the Journal of the American Medical Association. They explained that in the highly politically charged environment surrounding flibanserin it is difficult for the FDA to balance a number of issues:

Firstly, the Even the Score consumer advocacy campaign mobilised a groundswell of support, campaigning on the platform of gender equality in medicine.

Secondly, there were concerns about the validity of the outcome measure used in new evidence provided to the committee following two previously unsuccessful attempts to gain FDA approval. The usefulness of the outcome measure (retrospective recall of sexual satisfaction over a month), however, was not the focus of the committee discussions.

Thirdly, there was considerable speculation about the way the drug would be likely to be used in clinical practice, and the committee noted significant concerns about the risks associated with potential off-label use of the drug.

The scientific advisory committee clearly recommended approval reluctantly, and the authors of the JAMA article note that:

“The FDA regulates drug approval and marketing, not the practice of medicine. The Committee’s discussions about flibanserin and off-label use highlight the challenge that the FDA encounters when considering a product that may help a subpopulation of patients, but also has a risk-benefit profile that may make it unacceptable for broader use.”

Today’s FDA decision to approve flibanserin ends weeks of speculation but is not unexpected. The question now is how women, their partners, their doctors, and society in general will embrace this new option.

Disclosure

Jayne Lucke is the Director of the Australian Research Centre in Sex, Health and Society at La Trobe University. She receives funding from the Australian Research Council and the National Health and Medical Research Council. She has served as a Director of Family Planning Queensland and been Chief Investigator on an ARC Linkage Grant that involves cash and in-kind support from Family Planning New South Wales and Bayer Australia. The Australian Research Centre in Sex, Health and Society receives funding from diverse sources listed in the annual report available from the website: http://www.latrobe.edu.au/arcshs