By Rita Rubin
WebMD Health News
Oct. 20, 2014 -- The FDA has approved six brand-name drugs to help men get an erection. But it has yet to green-light a drug -- a “pink Viagra” -- to help women distressed about their lack of libido.
While critics say the FDA has a gender bias when it comes to treating sexual problems, the agency says it carefully weighs the risks and benefits of all drugs it approves. Some experts say female sexual dysfunction is more complex, making it harder to treat.
The topic will be front and center at an FDA meeting this month, one in a series of 20 looking at “patient-focused drug development.”
The meeting on Oct. 27-28 will include statements from patients about the impact that female sexual dysfunction has had on their lives. It will also include a scientific workshop to discuss how to diagnose the disorder and measure how well medications for it work.
The charge that the FDA holds drugs to treat women’s sexual problems to a higher standard than those for erectile dysfunction has divided women’s and health organizations.
Even the Score is a campaign launched in June that’s backed by the drug companies of at least three potential treatments for female sexual dysfunction. A petition to the FDA posted by Even the Score on change.org had more than 16,000 signatures as of Oct. 17. “We urge you to work fairly and urgently toward a solution to an unmet medical need…” the petition states.
Meanwhile, the National Women’s Health Network and the American Medical Women’s Association, among others, have supported the FDA’s decisions not to approve a drug for female sexual dysfunction.
Cindy Pearson, executive director of the National Women’s Health Network, says while the FDA has not been immune to gender bias, that’s not at play here. “If it were gender bias, we would be yelling and screaming,” Pearson says. “The problem is the drugs. Our biology is so much more complicated than men’s.”
Female sexual response includes not only libido, or desire, but arousal and orgasm, or satisfaction.
“Pfizer put a lot of money…into testing Viagra in women,” Pearson says. “It just failed.”
PharmedOut, a Georgetown University Medical Center project, notes in a fact sheet entitled “Don’t need drugs to score” that the FDA has never approved any drug specifically to boost men’s libido or any other male sex problem other than ED, which usually isn’t related to a man’s sex drive.
Rejected 'Pink Viagra' Drugs
A decade ago, Procter & Gamble sought the FDA’s permission to market Intrinsa, a testosterone patch, for women who felt low sexual desire after having their ovaries removed. But the agency rejected the patch, saying it was only a little effective and could potentially raise women’s risks of breast cancer and heart disease.
source : Why Aren’t There Sex Drugs for Women?
