Call to Action: Write to the FDA Today!

The FDA is reviewing Insmed’s application for ARIKAYCE (inhaled liposomal amikacin) and the FDA needs to hear from you now. Please consider writing to the FDA to let them know why it’s so important that we finally have this approved therapy. The review deadline set by the FDA is September 28th. We do not know at this time whether the date will be extended, so please send your letter as soon as possible.

Below are some key points to incorporate in your message, and you can click here for a brief background on the advisory committee meeting. You can email your letter directly to the FDA using the instructions below.

  • Identify yourself (are you a patient or caregiver plus any details that may be relevant like age range and/or whether you are retired vs still in the workforce).
  • Indicate if you specifically have pulmonary nontuberculous mycobacterial disease, particularly if you have M. avium complex (MAC), and include information other related diagnoses.
  • Indicate if you participated in the clinical trials for inhaled liposomal amikacin or whether you have any kind of relationship with the sponsor companies.
  • Explain that you are concerned about the lack of patient focus in recent Agency deliberations on treatments specifically for inhaled antibiotics. Emphasize the Advisory Committee’s clear vote to recommend approval for patients with limited to no treatment options.
  • Focus on your experience with NTM and bronchiectasis, when you were diagnosed, and how the symptoms impact daily living. Explain how alleviating an NTM infection can be helpful to you in your life as a patient.
  • If you have used large amounts of systemic (oral/iv) antibiotics in order to treat your NTM infection, describe this in the letter and explain why you are concerned. Have you had side effects of antibiotic use that could be minimized if you were taking inhaled antibiotics?
  • Talk about how you manage your disease now and what burden the treatments place on you and your family.
  • Use numbers/data as much as possible. For example, how often you have exacerbations, hospitalizations or other disease impacts like use of IV antibiotics.
  • Describe what outcomes matter most to you. Why do issues like clearing the infection (culture conversion) matter to you.
  • Describe how clearing your NTM lung infection would impact your life.
  • If you have participated in a study of inhaled liposomal amikacin, describe the impact you experienced when on the drug.
  • Remember, you are the expert on YOUR EXPERIENCE with the condition and its treatment – there are no right or wrong statements.

How to send your letter

  1. Address the letter to:

Dr. Janet Woodcock

Director, Center for Drug Evaluation and Research

Acting Director, Office of New Drugs

U.S. Food and Drug Administration

10001 New Hampshire Ave., Hillandale Bldg., 4th Floor

Silver Spring, MD 20993

 

  1. Send your letter, either in the body of the email or as an attachment via email, to the following;
    1. Janet.Woodcock@fda.hhs.gov
  1. In the “CC” field of your email enter the following addresses
    1. Sumathi.Nambiar@fda.hhs.gov
    2. Edward.Cox@fda.hhs.gov
  1. If you are sending your letter via attachment, you can write a simple note like the following in the body of your email:

Dear Dr. Woodcock,

As a patient with NTM lung disease I respectfully submit the attached letter for your consideration. I appreciate your time and consideration of the patient perspective in your decision making.

Regards,

Xxxx

Click here to read NTMir’s letter to the FDA