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Last updated on April 19, 2014 at 9:20 EDT

Coalition for Pulmonary Fibrosis Speaks Out for PF Patients, Families in Public Forums at FDA, PCORI

October 31, 2012

Agencies Request input from Patients, Families

CULVER CITY, Calif., Oct. 31, 2012 /PRNewswire-USNewswire/ — The Coalition for Pulmonary Fibrosis (CPF) spoke out for the more than 128,000 people suffering from Pulmonary Fibrosis (PF) and their families at recent forums that asked for patient comment on efforts related to drug development and research. The efforts were with the Food and Drug Administration’s (FDA) new congressionally mandated Patient-Focused Drug Development program and the congressionally authorized Patient-Centered Outcomes Research Institute (PCORI).

The CPF attended meetings at the FDA that were held to allow patient input on the drug development process per the congressionally mandated Patient-Focused Drug Development Program. The initial meetings were held on October 10th and October 25th. The public may comment until the November 1 deadline on disease areas to be included in what the FDA is calling a five-year pilot program. The program is intended to incorporate patient experiences with diseases to help guide the process leading to drug approval decisions.

The FDA set a preliminary list of diseases that range in severity from non-life threatening conditions to deadly ones. Though PF has no approved therapies and is imminently deadly, it is not included in the preliminary list.

The CPF and its Scientific Advisory Board submitted official comment to the Federal Registry and nearly 1,800 patients have sent letters to the FDA’s commissioner on the matter. To submit a letter to the FDA supporting the inclusion of PF in the disease areas of this new program go to: http://cpf.convio.net/site/Advocacy?pagename=homepage&id=163

In addition, members of Congress have publicly supported the request for PF to be included in the patient-focused FDA program. Senator Christopher Coons (D-DE) and Representative Erik Paulsen (R-MN) co-wrote a letter they submitted to the FDA. It is expected that other members of Congress will send letters before the deadline. To view their letter, click here: http://www.coalitionforpf.org/cpf_events_detailes.php?id=592

The CPF also participated in a workshop on October 28th of the Patient-Centered Outcomes Research Institute (PCORI), an organization authorized by Congress to conduct research to provide information about the best available evidence to help patients and their health care providers make more informed decisions. PCORI’s research is intended to give patients a better understanding of the prevention, treatment and care options available, and the science that supports those options.

“We take seriously our commitment to patients and families fighting Pulmonary Fibrosis. We want to make sure their voices are heard in forums that are critical to making progress in this disease,” said Mishka Michon, CEO of the Coalition for Pulmonary Fibrosis.

To learn more about the efforts of the CPF on behalf of patients and families, visit www.coalitionforpf.org.

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 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 501(C)(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 U.S. With more than 26,000 members nationwide, the CPF is the largest nonprofit organization in the U.S. dedicated to advocating for those with PF. For more information please visit www.coalitionforpf.org or call (888) 222-8541.

SOURCE Coalition for Pulmonary Fibrosis


Source: PR Newswire