-
What is Patient-focused Medical Product Development (PFMPD)?
For several years, Congress and patient advocates have been demanding that patients have a greater voice in the FDA product review process. For too long, patients were seen largely as customers or as participants in clinical trials but were rarely viewed as partners in this work.
This view is now changing thanks to patient-focused medical product development or PFMPD for short. Simply put, PFMPD provides opportunities for patients to be more involved in the FDA’s drug review process. The AWAKE Sleep Apnea PFMPD meeting is the first PFMPD meeting — it will cover both drugs and medical devices (such as CPAP).
-
How is a PFMPD meeting different from an FDA-hosted meeting?
In 2012, the FDA committed to convene 20 meetings organized around specific diseases or conditions to hear directly from patients about what it is like to live with serious and life altering conditions. This program developed the prototype for the PFPMD meeting and was well-received by patient groups. Demand for these meetings far outpaced the agency’s ability to convene them, which necessitated development of another meeting route.
In late 2015, FDA developed the externally-led meeting option whereby patient communities like ours (The American Sleep Apnea Association) can serve as organizers. The FDA must still grant requests for such meetings and will attend these externally-led meetings, using a format similar to those used by meetings hosted by FDA.There have been approximately 40 meetings held so far, including those hosted by FDA and patient organizations.
-
How will the information from the survey and meeting be used?
The ASAA will develop a report containing the information from the meeting as well as the Patient and Caregiver Survey that summarizes the community’s perspective on life with this disease and what our community wants to see in new treatments for sleep apnea. This data will inform how FDA views the unmet medical needs for those living with sleep apnea, how people living with sleep apnea trade off benefits of therapies and potential risks, and what the burden of currently available therapies is for individuals.
-
How will this meeting impact our community?
The intent of the patient engagement movement is to ensure that the FDA understands the perspectives of patients impacted by a disease or condition and keeps those in mind when reviewing prospective treatments as well as the safety of treatments on the market. We want and need the FDA -- as well as physicians, researchers, and life science companies -- to better understand the sleep apnea patient journey so they can develop and deliver better care.
-
How will we know if the meeting is successful?
First and foremost, a successful PFMPD meeting will require a large and diverse group of patients to actively participate and share their stories and perspectives. FDA officials have been clear that they want and need input from a large enough sample of people with sleep apnea to have confidence we are capturing information on the diverse nature of the condition and its wide variety of impacts.
Beyond a well-attended and vibrant meeting and robust survey participation, The American Sleep Apnea Association will summarize the findings and recommendations and have follow-up engagement with the agency to ensure the perspectives and views aired are heard and inform agency decision-making.
-
How can I view the meeting recording?
-
Where do I get a copy of the report?