The Food and Drug Administration (FDA) is responsible for deciding if new drugs and medical devices are safe and effective based on data typically produced by years of clinical trials. But, did you know that the FDA also considers information provided by patients when deciding whether to approve a new treatment or device?

Currently, there are no treatments that the FDA has approved specifically for bronchiectasis. On January 11^th, 2018 the FDA will convene a meeting of the Antimicrobial Drugs Advisory Committee to review the potential new treatment, Linhaliq, and make a recommendation to the FDA on whether or not to approve it for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections withPseudomonas aeruginosa. The new treatment is made by Aradigm. It is an inhaled version of ciprofloxacin that has undergone several clinical trials to evaluate if it extends the time to the first exacerbation compared to a placebo treatment. The potential to have new treatments indicated specifically for those with chronic lung infections with pseudomonas aeruginosa is particularly important for patients, because patients report a worse quality of life and have more hospital stays when pseudomonas aeruginosa is present.

Only you can truly help the Advisory Committee members who will review the new treatment understand what the unmet medical need is and what living with bronchiectasis is like. What type of impact do frequent lung infections and hospitalizations have on you? How are you currently managing your disease and what type of burden does that treatment place on you? How often do you end up on IV antibiotics every year?

These are just a few of the questions that you can address by participating in an open call for written comments leading up to the January 11^th FDA hearing. During the meeting, the Advisory Committee is only able to set aside about an hour for public comments, which means not everyone at the meeting will have the opportunity to speak. Written comments are a great way to ensure that your voice can still be heard and your perspectives on life with bronchiectasis can be considered by the Advisory Committee members. At the end of the meeting, the Advisory Committee members vote on a series of questions that amount to a recommendation on whether the FDA should approve the new treatment. It is then up the FDA to make an official decision, but it is rare that they go against the recommendation of an Advisory Committee, making the opportunity to share your experiences with the disease even more important.

Ready to write a letter to the FDA? Here are a few tips to think about when writing.

• 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 bronchiectasis with the presence of Pseudomonas aeruginosa.
• Focus on your experience with the disease, when you were diagnosed, and how the symptoms impact daily living.
• Talk about how you manage your disease now and what burden the treatments place on you.
• Use numbers/data as much as possible.  For example, how often you have exacerbations, hospitalizations or other disease impacts like use of IV antibiotics.
• Discuss what benefits you would like to have in a new therapy (other than a complete cure).
• If you have participated in a study of inhaled ciprofloxacin, 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.

We have included instructions on how to submit your comments below. The deadline to submit comments to the Advisory Committee before the hearing is December 27^th. If you submit your comments between December 28^th and January 10^th they will not be used by the Committee but can be taken into consideration by the FDA officials who make the final decision whether to approve the treatment.

If you have questions about what to include in your comments or the process of submitting them into the online regulations.gov portal you can email us at bronchiectasiscomments@copdfoundation.org

To Submit Your Written Comments

Visit the online comments portal at https://www.regulations.gov/document?D=FDA-2017-N-6293-0001. This is a direct link to the form for this meeting. For your reference, the docket number is FDA-2017-N-6293.

2. Click "Comment Now" on right side of the screen near the top.

3. In the "Comment" box write a short statement indicating your comments have been uploaded as a separate document. The character limits in this section are likely too short to copy your statement here.

4. Choose upload files and select your statement from the folder you have stored it in on your computer

5. Provide your information and make sure to click "I want to provide my contact info" and unclick the third-party option if it is pre-clicked

6. Under the category drop down menu-please select "Individual Consumer"

8. Review the information and then click "I read and understand the statement above"

9. Click "Submit Comment"