A Brief History of Our Lobbying Efforts in 2015


In April, 2015, we sent this letter to the FDA Committee:

Sent: Thursday, April 02, 2015 12:17 PM
Subject: on line patient community at cysticfibrosis.com

Dear Dr. Hong,

We run an on line patient community at cysticfibrosis.com. Several thousand of our community are very eager to reach out to you concerning the upcoming deliberation for the NDA lumacaftor/ivacaftor.

We wonder if this is the best email to tell our stories and encourage you to vote in favor of this medication.

Please let us know the best way for the community to approach your committee and if this is a good email to which we may petition.

Thank you for any help or advice you can give us.


They answered:


Yes, this is the email address to send all written submissions to for the May 12th PADAC meeting.
Thank you,


AboveAllIsLove sent us this Example letter we sent to the FDA Committee


A New Drug Application for the lumacaftor/ivacaftor combination is under consideration by the FDA. The Pulmonary-Allergy Drug Advisory Committee will be holding a public meeting on May 12, 2015 to discuss the application and to provide advice to the FDA.

You have the opportunity to submit written information and views directly to the Committee.
Email PADAC@fda.hhs.gov


Members of cysticfibrosis.com have created a sample letter you may want to copy and send directly to the committee at:

Pulmonary-Allergy Drug Advisory Committee
Docket No. FDA-2015-N-0001
NDA 206038

Of course, you may write your own email, and in both cases you may take the opportunity to add your personal stories.
Dear Committee Members,

I have Cystic Fibrosis [or insert appropriate relationship]. I write in support of the NDA (New Drug Application) for lumacaftor/ivacaftor and strongly urge the Committee to recommend this drug to the FDA for approval.

I recognize that the mean FEV improvement shown in clinical trials is modest when compared to ivacaftor, but even a modest improvement in FEV, when living with a degenerative disease, is a huge benefit. Further, this drug offers the chance for patients to remain stable until better drugs are available. Moreover, in reviewing the NDA, I urge the Committee to consider the very real benefit this drug offers to those with Cystic Fibrosis in the form of reduced exacerbations, improved weight, and overall improved quality of life.


Some examples for your personal to add in your personal stories:
FEV Improvement: The drugs improve FEV between 2-4% over placebo. Has your FEV been continually declining? What would stabilizing FEV and having a slight increase in FEV mean to you?
Exacerbations: The drugs reduce exacerbations significantly. What does an exacerbation mean to you? Lost work? Lost school? Expenses? Did you come out of the hospital with another infection? MRSA? Are you resistant to antibiotics now because you’ve used them so much? Did you have negative reactions to antibiotics? Do you have invasive testing because of infections?
BMI: The drugs improve BMI. Do you struggle trying to gain weight? Do you have a feeding tube? Is eating enough always a battle?
Quality of Life: The drugs improve Quality of Life. What do you do to keep your lungs healthy? How much time a day? This is a pill. It could add to your health with a minor treatment burden. Do you have lots of GI issues that might be resolved?
These are just some thoughts and suggestions from our community.
The more personal the illustration, tied to the scientific data, the better.


May 12:  The hearing

July 5th the decision


In September AboveAllIsLove sent us this link:


Members on the drug check in:

For people taking Orkambi



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