Advisory Panel Says FDA Should Not Approve Drug To Address Female Sexual Dysfunction

Main Category: Women's Health / Gynecology
Also Included In: Sexual Health / STDs;  Regulatory Affairs / Drug Approvals
Article Date: 22 Jun 2010 - 4:00 PDT


On Friday, an FDA advisory panel voted 11-0 against recommending FDA approval of a proposed treatment for hypoactive sexual-desire disorder, which decreases women's sex drive, the Wall Street Journal reports.

The Reproductive Health Drugs Advisory Committee reviewed an application seeking FDA approval of the drug flibanserin, also known as the "pink pill" or "female Viagra." Although the agency is not required to follow the panel's recommendation, it typically does (Corbett Dooren, Wall Street Journal, 6/18).

The drug's effects on women's sexual drive was "not robust enough to justify the risks," which included dizziness, fatigue and nausea, particularly with long-term daily use, according to Julia Johnson, chair of the advisory panel and head of the department of obstetrics and gynecology at the University of Massachusetts Medical School. She added that the drugmaker -- Germany-based Boehringer Ingelheim -- should continue to pursue research on the drug (Wilson, New York Times, 6/18).

According to the Journal, the panel's recommendation "wasn't surprising" because FDA released a background document last week with a "fairly negative review" of the drug. The company submitted data involving about 2,400 women for about six months treated with either flibanserin or a placebo months. FDA scientists said the drug did not show an increase in the women's libido, although some women reported an increase in their number of sexually satisfying events. The document noted that it was "not clear whether the safety and efficacy data from these trials are generalizable to the target population for this drug."

Boehringer said that women with HSDD have "extremely limited" treatment options and that flibanserin provided "clinically relevant" data for the drug's efficacy (Wall Street Journal, 6/18). Christopher Corsico, the company's U.S. medical director, said in a statement that the company is "disappointed with the advisory committee's recommendation and will work with the FDA to address questions raised" (New York Times, 6/18).

Drug Marketing 'Bigger Issue' in Flibanserin Review, Los Angeles Times Editorial Says

A Los Angeles Times editorial states that Boehringer "appears to be undertaking a marketing program to suggest to women that they might have a problem -- a problem that could be solved by the new drug." It adds, "A better drug for sexual desire disorder might come before the FDA, but that won't solve the bigger issue of how much we allow marketing to encourage our use of pharmaceuticals for things we hadn't necessarily thought of as pathologies before" (Los Angeles Times, 6/19).

CBS, NBC Discuss Drug Review

CBS' "Evening News" examined whether flibanserin "is a medical necessity, or simply a marketing scheme." The segment included comments from Elena Yancher, a health sociologist at Georgetown University Medical Center (Miller, "Evening News," CBS, 6/18).

On NBC's "Nightly News," chief medical reporter Nancy Snyderman discussed the panel's recommendation, noting that there is "no issue" about the validity of HSDD as a legitimate medical condition (Holt, "Nightly News," NBC, 6/18).

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