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FDA to Address Female Sexual Dysfunction

The federal agency will convene a two-day workshop in October to discuss the development of drugs to treat the issue.

By | August 15, 2014

WIKIMEDIA, SERGIO FABARA MUNOZFemale sexual dysfunction (FSD) may be inching out of the pharmaceutical industry’s shadows as the US Food and Drug Administration (FDA) has announced a two-day, late-October meeting on the issue. The FDA announced on Monday (August 11) that it will convene a workshop on October 27 and 28. The agency has set aside time to hear from FSD patients, researchers, and clinicians who have experience with FSD.

The move comes after critics, such as the Even the Score coalition have complained that the FDA hasn’t approved a single drug to treat FSD, while the agency has approved six types of drugs, sold under 25 different names and formulations, to treat male sexual dysfunction.

Cindy Whitehead, CEO of Sprout Pharmaceuticals—which is currently seeking FDA approval for an FSD drug—told The Wall Street Journal’s Pharmalot that she welcomed the move by the agency. It’s “positive to see that FDA has recognized FSD as one of their 20 priority areas of unmet need under the Patient Focused Drug Development Program,” she wrote in an e-mail. “Based on their outlined goals, this meeting will bring the patient voice forward regarding the impact of living with the most common form” of FSD.

But Sally Greenberg, executive director of the National Consumers League, which is part of the Even the Score coalition, told Pharmalot that she was conflicted about the upcoming workshop. “I am of two minds,” she said. “On one hand, it indicates the FDA is paying proper attention and taking seriously the condition. On the other hand, much of this information and data has been reviewed by FDA for years and we still have 26 approved treatments for male sexual dysfunction and zero for women.”

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