I received an e-mail from The Coalition for Pulmonary Fibrosis regarding their request for letters being sent to the FDA to add Pulmonary Fibrosis to a list. The list is of other disease areas to be addressed by the new Patient-Focused Drug Development program at the FDA.
Thank you to those who sent in the one of 1,500 letters.
Here is the e-mail:
The Coalition for Pulmonary Fibrosis asked for our members' help concerning a key issue -- that Pulmonary Fibrosis (PF) isn't listed as a disease area that may be addressed by the new Congressionally mandated Patient-Focused Drug Development program at Food & Drug Administration (FDA) (for the disease areas FDA includes, see pasted at the bottom of this email).
We asked you to send letters to the FDA asking them to include PF.
YOU answered our call! Thank you! More than 1,500 letters have gone to the FDA in the last couple of weeks. The comment deadline from the public on the issue was yesterday.
Also, our Champions in Congress sent a letter of their own to the FDA asking for PF's inclusion in the program! Click here to see the letter. Join us in thanking Senator Chris Coons (D-DE) and Representative Erik Paulsen (R-MN) and their staffs for asking for the FDA's help in PF! They are championing PF efforts, as well, with the Pulmonary Fibrosis Research Enhancement Act (H.R. 2505, S. 1350).
The CPF understands there are limitations on the number of diseases the FDA can address, but it is our role to encourage attention to PF, and we appreciate your willingness to join in that effort.
Sincerely,
Mishka Michon, CEO of the Coalition for Pulmonary Fibrosis
Reference:
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.
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