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Pulmonary Fibrosis Patients, Advocacy Groups Applaud FDA Decision to Add Untreatable Lung Disease as Part of Five-Year Patient-Focused Drug Development Program

Coalition for Pulmonary Fibrosis logo
Pulmonary Fibrosis Foundation logo
Coalition for Pulmonary Fibrosis logo

CULVER CITY, Calif., April 16, 2013 (GLOBE NEWSWIRE) -- The Coalition for Pulmonary Fibrosis (CPF) and the Pulmonary Fibrosis Foundation (PFF) today applaud the FDA for including Idiopathic Pulmonary Fibrosis (IPF, also known as Pulmonary Fibrosis, PF) on a list of 16 diseases the FDA will focus on for the first three years of its five-year Patient-Focused Drug Development Program. The list was announced April 11th in the Federal Register.

The CPF and PFF jointly urged the FDA to include IPF/PF on the list for the federally mandated program at the FDA's public comment meeting on October 25, 2012. In addition, more than 2,000 patients, family members and medical professionals sent letters sent to the FDA asking for PF to be included in the Patient-Focused Drug Development Program.

"The FDA heard the voice of the PF community," said Mishka Michon, CEO of the CPF. "We are pleased PF will be included in this important FDA initiative and we believe our community's involvement in the FDA's effort to include patient input in disease areas will accelerate the search for treatments and a cure for PF."

"We are extremely grateful to the FDA for including us in the Development Program. We are hopeful and optimistic that this will facilitate the development of more effective therapies for this devastating illness," said Daniel M. Rose, MD, Chairman and CEO of the PFF.

PF had not been included the FDA's preliminary list of 39 diseases published in the Federal Register on September 24, 2012.

2,000 Letters

The CPF and PFF asked the PF community - patients, their family members, caregivers and medical professionals - to send letters of support for the inclusion of PF in the Patient-Focused Drug Development Program to FDA Commissioner Margaret Hamburg. Congressman Erik Paulsen (R-MN) and Senator Christopher Coons (D-DE), who have led PF legislative efforts in the U.S. House and Senate, also wrote a joint letter asking the FDA Commissioner to include PF in the program.

Over half of Public Comments included Interstitial Lung Disease

According to the FDA, over half of the comments it received regarding diseases to be included in the Patient-Focused Drug Development Program were from supporters of Interstitial Lung Disease (ILD - a category including 300 lung diseases; Pulmonary Fibrosis is the most common form of ILD), lung cancer, and narcolepsy. In addition, a common co-morbid condition for patients with PF, Pulmonary Arterial Hypertension (PAH), received a large number of comments and was also placed on the list.





According to the FDA's published general schedule of its disease-specific meetings, a workshop on PF will be held in fiscal year 2014 or 2015. The first disease-focused workshop for the FDA program will be held on April 25th on Chronic Fatigue Syndrome and Myalgic Encephalomyelitis.

FDA Decision Criteria

The FDA indicated that the final list of diseases selected were based on the following criteria: "Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living; disease areas for which aspects of the disease are not formally captured in clinical trials; and 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 or functions." Also the perspective of reviewing divisions at the FDA and the input from the public were considered as the FDA determined the final list.

Background on FDA Federally-Mandated Program:

The five-year initiative fulfills the FDA's federally mandated performance commitments, which are part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The program's purpose is to provide a more systematic approach for the FDA to obtain patients' input on specific disease areas, including their perspectives on their condition, its impact on daily life and available therapies.

To view the FDA's announcement of the disease areas chosen and published in the Federal Register on April 11, 2013, visit: http://www.gpo.gov/fdsys/pkg/FR-2013-04-11/pdf/2013-08441.pdf.

About Pulmonary Fibrosis (PF)

Pulmonary Fibrosis (PF) is a lung disorder characterized by a progressive scarring – known as fibrosis -- and deterioration of the lungs, which slowly robs its victims of their ability to breathe. Approximately 128,000 – 200,000 Americans suffer from PF, and there is currently no known cause or cure. An estimated 48,000 new cases are diagnosed each year. PF is difficult to diagnose and an estimated two-thirds of patients die within five years of diagnosis. Sometimes PF can be linked to a particular cause, such as certain environmental exposures, chemotherapy or radiation therapy, residual infection, or autoimmune diseases such as scleroderma or rheumatoid arthritis. However, in many instances, no known cause can be established. When this is the case, it is called idiopathic pulmonary fibrosis (IPF).

About the CPF

The CPF is a 501C(3) nonprofit organization, founded in 2001 to accelerate research efforts leading to a cure for pulmonary fibrosis (PF), while educating, supporting, and advocating for the community of patients, families, and medical professionals fighting this disease. The CPF funds promising research into new approaches to treat and cure PF; provides patients and families with comprehensive education materials, resources, and hope; serves as a voice for national advocacy of PF issues; and works to improve awareness of PF in the medical community as well as the general public. The CPF's nonprofit partners include many of the most respected medical centers and healthcare organizations in the United States. With more than 26,000 members nationwide, the CPF is the largest nonprofit organization in the country dedicated to advocating for those with PF. For more information please visit www.coalitionforpf.org or call (888) 222-8541.

About the Pulmonary Fibrosis Foundation

The mission of the Pulmonary Fibrosis Foundation (PFF) is to help find a cure for idiopathic pulmonary fibrosis (IPF), advocate for pulmonary fibrosis community, promote disease awareness, and provide a compassionate environment for supporting patients and their families. The PFF collaborates with physicians, organizations, patients, and caregivers worldwide. December 1-3, 2011 the PFF hosted its first biennial international scientific conference, IPF Summit 2011: From Bench To Bedside, in Chicago; PFF Summit 2013 will be held December 5-7, 2013 in La Jolla, California. For more information visit www.pulmonaryfibrosis.org or call 888-733-6741

CONTACT: Teresa Barnes Coalition for Pulmonary Fibrosis tbarnes@coalitionforpf.org 303-521-4080 Patti Tuomey Pulmonary Fibrosis Foundation ptuomey@pulmonaryfibrosis.org 888-733-6741 or 312.239.6724

Source:Coalition for Pulmonary Fibrosis(CPF)