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:
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:
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!
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.
Sincerely,[Your Name] [Your Address] [City, State ZIP]
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