Important and Needs Your Help

An extremely urgent e-mail was received from The Coalition for Pulmonary Fibrosis. With the changes to our medical system, it is so important that PF is added to the list. All the information is below as well as a form letter you can send to the FDA.

The Coalition for Pulmonary Fibrosis is concerned because 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(see background section below for list of diseases FDA plans to include).  

The program resulted from the Prescription Drug User Fee Act passed by Congress this summer (Pulmonary Fibrosis was even an example for the need for the bill's passage by a member of Congress in a Senate hearing on the bill and yet the FDA didn't include it!).

What the CPF needs you (and your friends and family) to do --

Please send a message NOW to the FDA's Commissioner Margaret Hamburg! (We have written it for you to make it easy! - you can customize it).  Click here to send message!  DEADLINE is OCT. 18, but send your message now please!

FDA will consider the public comments (including yours!) received -- at a public meeting (the CPF will be in attendance representing PF patients) and will post the set of disease areas for FY 2013-2015 on the FDA Web site (www.fda.gov) after the meeting on October 25th. By the end of Fiscal Year 2015, FDA will initiate another public process for determining the list of disease areas for FY 2016-2017 and we will let you know when that happens.

Pasted below is the list FDA considers to be a priority (PF is NOT on the list!) as well as background information on this FDA effort. We need your help in sending FDA a message that PF must be included.  Please send your message now! Click here!

Thank you!

Sincerely, 

Mishka Michon, CEO of the Coalition for Pulmonary Fibrosis

Background:  

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 (click here) that answers the criteria set forth by the FDA on what they are looking for in order to consider disease areas. HURRY, the FDA DEADLINE for your INPUT is October 18th!

Here is what the FDA said about their list of preliminary diseases (of which PF was not a part): [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.

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.

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.