The FDA’s Patient Focused Drug Development Initiative highlights the power and value of patient advocacy groups in the US

FDA to Focus on Female Sexual Disorders at Upcoming Patient Meeting

In Advocacy, Regulation & Government by CecileLeave a Comment

After Criticism, the FDA Announced That it Has Plans to Hold a Patient-Focused Drug Development Meeting on Female Sexual Dysfunction

This week, it was announced that the FDA will plan a meeting addressing female sexual dysfunction as part of an initiative to involve patients more in the drug development process and to give their input on clinical trials and other aspects of drug research.

These patient-focused meetings have taken place since the 2012, when the FDA Safety and innovation Act was signed by President Obama. This act was created to help patients suffering from rare diseases and conditions without effective treatment options.

These meetings give patients the chance to give an indication as to how much risk they are willing to place themselves in, particularly in clinical trials, to aid in the development of new treatments. Meetings that have already taken place have covered conditions such as lung cancer, hemophilia A and B, HIV, narcolepsy and Chronic Fatigue Syndrome (CFS.)

The 11th patient-focused drug development meeting will address Female Sexual Dysfunction. FSD is a term that covers many different conditions which can impact on a woman’s sexual arousal, causing problems with reaching orgasm and even painful sexual intercourse.

The FDA has approved some products to treat specific subsets of FDS, such as Osphena for postmenopausal women experiencing pain during intercourse and the EROS clitoral therapy device for women who have difficulty reaching orgasm.

Despite these approvals, there have still be many failed attempts to bring other products to market.

The two main topics that will be addressed at the meeting are: the impact of one of the most common subsets of FSD, female sexual arousal disorder and views on the available therapies to treat it.

The meeting will be held on the 27-28th of October 2014 at the FDA’s White Oak campus in Maryland.

Read more about it here: Patient-Focused Drug Development Public Meeting and Scientific workshop on Female Sexual Dysfunction

 

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