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January 30, 2014 Dr. Janet Woodcock (janet.woodcock@fda.hhs.

gov) Division of Drug Information (CDER) 10001 New Hampshire Avenue Hillandale Building, 4th Floor Silver Spring, MD 20993 Dear Dr. Woodcock: On behalf of our organizations, we would like to thank you for meeting with us on January 28th to discuss our collective concerns on the lack of parity in the evaluation of a medical treatment option for womens sexual dysfunction, especially compared to the myriad of already approved treatments for men. We were pleased, Dr. Woodcock, with your recognition that 24 treatment options for men contrasted with an ongoing dilemma to just approve one for HSDD in women may signal gender bias, conscious or unconscious. Further, we applaud the acknowledgement that HSDD may have been historically undervalued despite the profound impact it has on one in 10 women, and its longstanding recognition as a condition in the Diagnostic and Statistical Manual. We see this not only as an important unmet womens health issue, but an inflection point for the agency to ensure that similar standards are applied for drug approvals in conditions uniquely affecting women. You heard our concerns priority review granted for the first male ED drug while denied for this application, clinical trial requirements that go well beyond the standard new indication approval across drug categories with trial sizes more than double the number of subjects studied for the first approval in ED; finally, risk/benefit assessment that seems inconsistent with what has sufficed historically for male drugs whether they are dosed daily or episodically. While we were very grateful for the meeting, what we heard from your staff was of concern. Of particular note, an FDA staff member lead to believe that there are safety, efficacy or other issues we are unaware of, but then said she was unable under FDA rules to explain what those concerns were. While we understand that the policy of the agency may be to not discuss a drug under review, that was a provocative statement that we believed required follow up. As such, we asked the company to share their confidential dispute document and proposed labeling for the drug openly with us and they did so willingly. We have now reviewed that information, and we see nothing in those documents to warrant heightened concern, as FDA suggested this information would. Indeed, we arrive at the same conclusion. This is an important unmet medical need for women. We have an opportunity to take the first step toward leveling the playing field by approving the first medical treatment option for HSDD. The magnitude of the data has informed predictable treatment effects not modest but meaningful to the women in


trials and side effects that can be addressed in labeling just as they have been for other approved drugs. The risk/benefit evaluation is well characterized for this treatment and must now be handed over to the women affected by this condition and their healthcare providers who we feel confident are capable of making those decisions. We respect the diligence you have applied for this important first-of- its-kind approval. But it has now been studied in 15x the number of patients as the median new drug approval, as reported in the Journal of the American Medical Association last week. You have heard from clinical experts, womens health advocates and Congresswomen, and we all agree that it is time to take immediate action. By doing so, not only will the agency meet its objective to protect public health by curtailing the rampant use of unapproved drugs women turn to today in the absence of an approved and labeled product the agency will also meet its goal to advance healthcare by finding solutions for unmet medical needs. Before the agency renders a critical decision next week that has far reaching implications for women and womens health, we wanted to let you know we have followed up and feel firmly the same it is time to label and approve the first drug for the treatment of the most common form of female sexual dysfunction. What a remarkable opportunity this is for the FDA to break down an important barrier and long standing discrepancy and for us to celebrate your action in doing so. Sincerely, Sally Greenberg Executive Director, National Consumers League Phyllis Greenberger President & CEO, Society for Womens Health Research Jan Erickson Government Relations Director, National Organization for Women Gay Johnson CEO, Nurse Practitioners in Womens Health Serra Sippel President, Center for Health and Gender Equity Susan Scanlan Chair Emeritus, National Council of Womens Organizations Lori Weinstein CEO & Executive Director, Jewish Women International


Anita H. Clayton, MD. Interim Chair, Department of Psychiatry & Neurobehavioral Sciences, University of Virginia; Past-President, International Society for the Study of Women's Sexual Health; Vice Chair for Women's Sexual Health, International Consultation on Sexual Medicine.