In response to the FDA request for comments on the patient-focused drug development initiative, the AHDA proposed that Migraine and Related Disorders be included as a disease area for the focused attention of a public meeting. In a letter to the FDA, Bob Shapiro advised that migraine meets and exceeds the five criteria outlined by FDA for inclusion in the initiative. To help our voice be heard go to the website at the end of this blog and help us make our case.
This week, the Food and Drug Administration (FDA) is holding a public meeting 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. So far Migraine and Related Disorders is NOT included.
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, very few diseases with more impact on a population basis than migraine and headache are on the list. It is unlikely that any disease on this list is as underfunded by NIH and the US government as migraine.
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. There’s an excellent summary of the background in Volume 77, Number 185 of the Federal Register.
Teri Robert will be representing The Alliance for Headache Disorders Advocacy and the American Headache and Migraine Association at a meeting in Washington this week. She will really be representing all persons with migraine and cluster headache.
We need to make sure our voice is heard! There is an opportunity for public comment before Nov 1. Please go online at http://www.regulations.gov/?source=govdelivery#!documentDetail;D=FDA-2012-N-0967-0001
Written comments are due by November 1, 2012.
William B. Young; MD, FAHS, FAAN
Jefferson Headache Center; Philadelphia, Pennsylvania
Vice President, Alliance for Headache Disorders Advocacy
Teri Robert, PhD
Patient Educator and Advocate
Secretary, Alliance for Headache Disorders Advocacy