Posted 13 August 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) this week quietly announced that it soon plans to hold a meeting on female sexual dysfunction (FSD) as part of a larger effort to bring patients into the drug development process to fine-tune its benefit-risk assessment process.
The meeting will be the 11th under FDA's Patient-Focused Drug Development process—an initiative created under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) to help patients suffering from debilitating conditions without adequate treatment options.
The underlying philosophy of the program is that patients—not regulators—are best able to determine the amount of risk they are willing to accommodate in a new treatment. Some legislators and patient groups have expressed concern in recent years that FDA is too risk-averse and focused on potential health risks of new treatments that, for some patients, are outweighed by the same treatment's potential benefits.
To date, FDA has either held or scheduled 10 patient-focused drug development meetings:
- Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis
- Pulmonary Arterial Hypertension (PAH)
- Lung Cancer
- Human Immunodeficiency Virus (HIV)
- Sickle Cell Disease (SCD)
- Neurological manifestations of inborn errors of metabolism
- Idiopathic Pulmonary Fibrosis (IPF)
- Hemophilia A, Hemophilia B, von Willebrand disease, and other heritable bleeding disorders
Female Sexual Dysfunction
Now FDA has announced its 11th, this time for FSD, a topic which has generated significant—if unwarranted—controversy in recent months.
FSD is not a single disease, but rather a collection of conditions which can negatively affect sexual desire and sexual arousal, and also result in difficulty achieving orgasm or in pain during sex. (Mayo Clinic) While FDA has approved a small handful of products (1, 2) over the last two decades which can help treat subsets of the disorder, attempts to bring other products to market have been unsuccessful.
FDA's two-day meeting is set to solicit patient perspectives on two aspects of FSD:
- the impact of the most common form of FSD, female sexual interest/arousal disorder (FSIAD) on daily life
- patients’ views on currently available therapies to treat the condition
Another two areas will receive attention during a scientific workshop on the second day of the meeting, which appears to be geared toward drug development professionals:
- diagnosis of the condition for clinical trials and in clinical practice
- ensuring valid patient-reported outcome measures for the key efficacy endpoints used in clinical trials
Questions Not Yet Asked
Unlike other meetings, FDA has yet to release the questions it intends to ask of patients at the meeting.
As detailed in Regulatory Focus' Patient-Focused Drug Development Tracker, FDA has asked each patient group between six and 16 questions about their respective conditions.
Common questions FSD patients can likely expect to be asked include:
- Of all of the symptoms that you experience because of your condition, which one to three symptoms have the most significant impact on your life?
- What are you currently doing to treat your condition or its symptoms?
- How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days?
- What are the most significant disadvantages or complications of your current treatments, and how do they affect your daily life?
- Are there specific activities that are important to you, but that you cannot do at all, or as well as you would like, because of your condition?
- How have your condition and its symptoms changed over time?
- If you could create your ideal treatment, what would it do for you?
The meeting will take place on 27-28 October 2014 at FDA's White Oak campus in Silver Spring, MD.
FDA Meeting on Female Sexual Dysfunction