The FDA Heard Us - the Pulmonary Fibrosis Patient Community - and PF is included in the FDA's Patient-Focused Drug Development Program! Thanks to you and every member of the PF patient community, including advocacy groups, patients, family members, caregivers and medical professionals, PF will be part of the initiative, even though we weren't on the preliminary FDA list! More than 2,000 CPF members sent letters to the FDA to Commissioner Margaret Hamburg and she and the entire FDA heard you!!
If you recall, the Coalition for Pulmonary Fibrosis spoke for members of the PF community at a key FDA meeting in October last year to ask that PF be included in an important new program at the FDA that will include patient input in the process of drug development.
This new drug development program resulted from the Prescription Drug User Fee Act passed by Congress last summer.
Also, PF Champions in Congress, Senator Christopher Coons (D-DE) and Erik Paulsen (R-MN) wrote a letter to FDA's commissioner, Margaret Hamburg asking her to include PF in the program.
The CPF remains committed to advocating for patients and families fighting PF and we look forward to working with the FDA on your behalf in this new Patient-Focused Drug Development Program at the FDA.
If you'd like to support our efforts to raise awareness for PF, you may make a tax-deductible contribution by clicking here.
Please see our full press release on this news pasted below.
Sincerely,
Mishka Michon, CEO of the Coalition for Pulmonary Fibrosis
Pulmonary Fibrosis Patients, Advocacy Groups Applaud FDA Decision to Add Untreatable Lung Disease as Part of Five-Year Patient-Focused Drug Development Program
CPF and PFF Joined Patients and Medical Professionals to Urge the Federally Mandated Program to Include Deadly Disease
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.
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