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Tell FDA to include PF in priorities for new program

The Coalition for Pulmonary Fibrosis is concerned that Pulmonary Fibrosis (PF) is NOT listed as a disease area that will be addressed by the new Congressionally mandated Patient-Focused Drug Development program at FDA that resulted from the Prescription Drug User Fee Act passed by Congress this summer.  

Pertaining to this issue, the FDA is requesting public comment on the disease listing (see below for the FDA's full preliminary list) and asking for patient and stakeholder input in asking that other diseases be considered.  To make it quick and easy for you, we have written a letter for you that answers the criteria set forth by the FDA on what they are looking for in order to consider disease areas.  

Here is what the FDA said about their list: [Docket No. FDA-2012-N-0967]

"FDA is nominating the following disease areas as potential candidates for the focus of one of the 20 future public meetings and invites public comment on this preliminary list. In your comments, please identify the disease areas that you consider to be of greatest priority and explain the rationale for your recommendation.

Here is the list FDA considers to be a priority below. We need your help in sending FDA a message that PF must be included.  

Preliminary Disease areas recommended by FDA:

  • Pulmonary arterial hypertension
  • Heart failure
  • Primary glomerular diseases
  • Narcolepsy
  • Huntington's Disease
  • Depression
  • Autism
  • Peripheral neuropathy
  • Fibromyalgia
  • Obesity
  • Nocturia
  • 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
  • HIV
  • Patients who have experienced an organ transplant
  • Sickle cell disease
  • Chronic graft versus host disease
  • Amyloidosis
  • Aplastic anemia
  • Melanoma
  • 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.

FDA is interested in public comment on disease areas that are not represented on this preliminary list. The Agency used several criteria to develop the preliminary list of potential disease areas. The FDA's criteria include the following:

  1. Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
  2. Disease areas that reflect a range of severity;
  3. Disease areas for which aspects of the disease are not formally captured in clinical trials;
  4. Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly); 
  5. Disease areas that represent a broad range in terms of size of the affected population; or
  6. Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.

FDA will consider the public comments received at a public meeting (the CPF will be in attendance representing PF patients) and through the docket and post the set of disease areas for FY 2013-2015 on the FDA Web site (www.fda.gov). By the end of FY 2015, FDA will initiate a public process for determining the list of disease areas for FY 2016-2017.

Send your letter now using this form to the FDA NOW in support of Pulmonary Fibrosis being added to the list of priorities at the FDA! 

Recipients

  • Margaret Hamburg

Contact

*Required fields
 
 

Message

Tell FDA to Include Pulmonary Fibrosis in Patient-Focused Drug Development

Dear [Decision Maker],

Thank you for accepting public comment on disease areas NOT represented in the preliminary list [Docket No. FDA-2012-N-0967] As someone who is impacted by Pulmonary Fibrosis (PF), I urgently encourage the FDA to include (PF) in the disease areas that will be part of the Patient-Focused Drug Development Initiative at the FDA. .

Pulmonary Fibrosis (also called Idiopathic Pulmonary Fibrosis or IPF) is a lethal lung disease that has NO FDA approved treatment and claims as many lives each year as breast cancer. The disease is unpredictable and patients die often very suddenly, via what is referred to as acute exacerbations. . PF causes increasingly extreme symptoms such as severe breathlessness, and chronic cough and ultimately, often within months of diagnosis, leaves the patient dependent on supplemental oxygen even to manage even the smallest of tasks. Most patients simply can barely function in daily life.

Patients' disease severity differs based on time of diagnosis as well as whether the disease is progressing rapidly, moderately or slowly. The average patient lives 3-5 years before death with the disease.

PF has relatively few clinical trials that are available to a wide range of patients and, as mentioned earlier, currently has no FDA approved treatment.

PF has historically, and continues to affect mostly older people - with an average age of diagnosis at 63 years of age. However, the disease can and does, more and more, strike teens, young adults and adults in their most productive years. The disease affects a known 128,000 to 200,000 people (the NIH uses 200,000, and the actual number may range from 500,000 to 1 million according to experts) but it is underrepresented due to undiagnosed and misdiagnosed cases. PF has few survivors in its wake. Only about one percent of patients survive due to lung transplantation.





It is my urgent request that the FDA include Pulmonary Fibrosis in its list of disease areas for FY 2013-15.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]

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