FDA Panel Votes to Approve ‘Female Viagra’ With Conditions After Third Hearing

The drug is produced by the pharmaceutical company Sprout. Cindy Whitehead, the founder and COO of the Raleigh, North Carolina-based company, has been fighting to get the drug approved for four years.

“There are 25 approved drugs for some form of male sexual dysfunction, but still a great big zero for the most common form of FSD [female sexual dysfunction],” Whitehead said in an interview with ABC News last year. “No matter how or why we got here, we’re here, and we’ve got to come up with a solution for it.”

The drug targets an issue more complicated than the physiological issue that men with erectile dysfunction face, according to gynecologist Dr. Lauren Streicher.

HSDD “is a very specific problem in a woman who doesn’t think about sex, she doesn’t fantasize, she doesn’t desire sex,” Streicher told ABC News last year. “What makes it different is that it’s distressing to her. This has a negative impact on her. She’s worried about it, she’s frustrated.”

Dr. Adriane Fugh-Berman, an associate professor at Georgetown University, is also the director of the medical center’s research project PharmedOut and said that she’s concerned about a drug that is taken every day for a condition that is not a disease.

“It’s not sexist for the FDA not to approve a drug that it doesn’t believe is effective or safe,” Fugh-Berman told ABC News last year. “It’s a classic marketing technique to first create a problem, and then sell the solution, and that’s what’s going on here.”

She told the Associated Press that some women may have a condition that will not be helped very much by drugs or chemicals.

“For those women therapy is the best solution, because this is not a medical disease,” she told the AP.

“The fundamental question is whether these observed placebo-corrected treatment effects outweigh the risks associated with treatment,” the FDA said in the brief released before today’s hearing.

ABC News’ Lauren Effron, Mara Schiavocampo and Jackie Jesko contributed to this report.

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