How many times have we felt that those in positions of power don't understand what it's like to live with Migraine disease, cluster headaches, or other headache disorders? Too many times to count. This is an issue that increases the burden of living with these disorders. It increases our feelings of frustration, isolation, and more.
Today, I want to share an opportunity with all of you and encourage each of you living in the United States to take advantage of it...
The Food and Drug Administration (FDA) is holding a public meeting next week related to FDA's patient-focused drug development initiative. The initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). This effort provides for a more systematic approach under PDUFA V for obtaining patient perspective on the disease severity and the currently available treatments. FDA is publishing a preliminary list of nominated disease areas for the patient-focused drug development initiative and the criteria used for nomination.
The list FDA has published in the Federal Register is a preliminary list for the program, not the final list. A final list of 20 disease areas will be selected for inclusion in this five-year pilot program. Then, quarterly, over the next five years, FDA will meet with stakeholders — patients, caregivers, physicians, and others — with an interest in one of the 20 disease areas for an in-depth review of the needs related to treatment, the current state of treatments, disease burden, the human side of living with the disease, and other issues of possible relevance to reviewing treatments that may come before the FDA for review. It's truly an interesting and potentially very valuable program, and I hope you want to know more about it. There's an excellent summary of the background in Volume 77, Number 185 of the Federal Register.
Those disease areas initially nominated as a starting point to develop the list of 20 for this program are:
- Pulmonary arterial hypertension.
- Heart failure.
- Primary glomerular diseases.
- Huntington's Disease.
- Peripheral neuropathy.
- Chronic fatigue syndrome.
- Irritable bowel syndrome.
- Inflammatory bowel disease.
- Alopecia areata.
- Diabetic ulcers.
- Female sexual dysfunction.
- Interstitial cystitis/painful bladder syndrome.
- Fracture healing.
- Diabetic foot infections.
- Hepatitis C.
- Patients who have experienced an organ transplant.
- Sickle cell disease.
- Chronic graft versus host disease.
- Aplastic anemia.
- Lung cancer.
- Cancer and young patients.
- Cancer treatment in pregnancy.
- Cancer and sexual dysfunction.
- Cancer and depression.
- Clotting disorders (e.g., hemophilia A (factor VIII deficiency) and von Willebrand disease).
- Thrombotic disorders (e.g., antithrombin deficiency and protein C deficiency).
- Primary humoral immune deficiencies (e.g., common variable immune deficiency).
- Neurologic disorders treated with immune globulins (e.g., chronic inflammatory demyelinating polyneuropathy).
- Hereditary angioedema.
- Alpha-1 antitrypsin deficiency.
As you can see, neither Migraine nor any other headache disorder is included in this preliminary list of nominated disease areas.