FDA Hearing: Ciprofloxacin Inhalation Powder
Posted on November 17, 2017 |
This blog post was written by Tracie Sullivan, Grassroots Manager, COPD Foundation.
My first week as a new staff member at COPD Foundation has been an exciting and busy one! Yesterday I had the pleasure of attending the Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee Meeting with six exuberant, welcoming, and passionate advocates. This committee hearing was discussing proposing a new drug application called ciprofloxacin inhalation powder, for reduction of exacerbations in non-cystic fibrosis bronchiectasis in adult patients with respiratory bacterial pathogens. The advisory panel is set up to make recommendations to the FDA about whether or not they should approve a drug. Committee members for this advisory council were made up of 16 individuals composed of doctors, medical professionals, higher education professors, clinical research, mathematical statisticians, consumer and patient representatives.
As the proceedings started, myself and my colleagues learned about the research behind ciprofloxacin inhalation powder, the results from the clinician trials, the biostatistics involved, and clinical safety. Once the afternoon session began, our advocates were able to stand in front of the committee members and share their stories with bronchiectasis. Our advocates included doctors, patients, and caregivers. Those who had been a part of the clinical trials and had seen significant improvements, and those who did not have the opportunity to be a part of the trial, and were looking for new medical treatment opportunities. These stories included the everyday challenges they face, the medical routes they must adhere to, the lifestyle changes they have had to make, and concerns about the lack of research and medical advancements. Each advocate discussed how this new and innovative drug could provide hope for individuals with bronchiectasis, how it could change their lives. How one less exacerbation could keep them out of the emergency room, could allow them to go to that family event they had missed years before, how their quality of life could be instrumentally improved.
These advocates are why I entered the advocacy field and why I love what I do. Their passion, their courage to tell their stories in front of others, and their dedication to bringing a voice and hope to individuals with bronchiectasis is humbling.
After each advocate was allotted time to speak, the committee thanked them for their time, and had a lengthy committee discussion regarding whether to recommend the proposal for ciprofloxacin inhalation powder. Before the vote, committee members addressed to the public that this was one of the most difficult votes and decisions they have had to make during their term. The initial vote was to slighted towards not recommending the proposal for ciprofloxacin inhalation powder, due to lack of conclusive data on its effects, and potential safety concerns regarding resistance. The committee emphasized the importance of the work the sponsor Bayer Pharmaceuticals was doing, and stated that they should not give up hope on this drug, nor the bronchiectasis community, as the committee did see a huge need and benefit. However, this is not the tell all end all; while the advisory committee votes on a recommendation, it is up to the FDA to ultimately consider the recommendations provided forward, and to provide a final decision to the public. Thus, decisions made yesterday were not binding and we cannot be 100 percent certain on what the final outcome will be.
Myself, and The COPD Foundation Community would like to send our sincerest thank you to all advocates that participated in this process. Although the preliminary outcome did not go as we had hoped, I know that your stories made a difference, and brought more awareness to the challenges, hopes, and needs of the bronchiectasis community. We will keep abreast and notify the community of when the FDA makes the final decision regarding the ciprofloxacin inhalation powder.