Patient-Focused Drug Development Meeting Resources
The U.S. Food and Drug Administration (FDA) and patient organizations use patient-focused drug development (PFDD) meetings as a tool to gather patients’ perspectives on living with their conditions and current and future therapies.
In 2013, FDA launched the PFDD initiative with plans to host 20 condition-specific meetings, a goal they have since surpassed. In 2015, after two years of demonstrated success, FDA shared the mantle and gave patient organizations the chance to host PFDD meetings (often called “externally led PFDD meetings”). Since then, patient organizations have successfully amplified the voices of countless patients.
Perhaps you’ve heard about the value of these meetings, or you’re currently planning one. Below is a collection of FDA and FasterCures resources for hosting PFDD meetings based on lessons from the field and specifically designed for those who are interested in hosting externally led PFDD meetings. To learn more about PFDD meetings check out our introductory blog on the topic.
How do you know when your organization and your community is ready for a PFDD meeting? This self-guided PFDD Readiness Assessment is designed to help you answer that question by asking you to reflect on the knowledge and capacity of your organization and the context of therapy development for your community. To use the Assessment, answer each question and tally your points as you go. At the end, evaluate your status using the scoring key. We’ll continue to update the Assessment with links to new resources.
This extensive guide details common practices, lessons learned, and considerations for planning PFDD meetings. The guide is based on interviews conducted with community leaders that have planned and hosted externally led PFDD meetings, and it has been checked for accuracy by FDA. It is organized chronologically into three planning sections: Section 1: Steps to Take Before Submitting a Letter of Intent, Section 2: Planning Your PFDD Meeting, and Section 3: Preparing for Post-Meeting Outcomes. Each section includes topics relevant to that planning period depending on where you are in your planning.
Many organizations developed tools and resources for PFDD meetings during their planning process. The PFDD Community Toolbox is a collection of materials that were donated by organizations that have hosted meetings. You’re encouraged to reference or adapt these tools for your PFDD planning purposes.
The PFDD Tracker located at the bottom of this page is a collated list of past and future PFDD and PFDD-like meetings, with links to resources such as reports, agendas, and archived recordings. You can also download a PDF version (Updated March 2019).
The Tracker is a work in progress. If you can contribute any additional information, please contact Brenda Huneycutt.
Panelists from FDA, the patient community, and FasterCures share their perspectives on the impact of PFDD and how it might continue to shape drug development and regulation. The panelists also discuss their experiences working with patient communities to plan for these often intense listening sessions, what they’ve learned, and how they’re applying this information.
A Note on These Tools
FasterCures developed these three tools based on internal expertise and interviews with patient advocacy groups that have hosted PFDD meetings. While FDA provided input on the accuracy of the content in the Smart Practices guide, all of these tools represent the perspective of FasterCures alone and do not necessarily reflect the perspectives of the organizations involved or the FDA. These tools do not set standards and will continue to evolve along with patient-focused drug development.
All questions related to externally led PFDD meetings should be directed to the FDA’s PFDD Program Staff.
It’s important to note that FDA will participate in, but will not officially sponsor or endorse, externally led PFDD meetings. The FDA encourages patient organizations to take the lead and has provided resources to facilitate this. We’ve collated these resources here.
- Patient-Focused Drug Development Program Staff
Contacts for any questions related to FDA led or externally led PFDD meetings.
- CDER Patient-Focused Drug Development (webpage)
- CDER homepage for patient-focused drug development
- Externally-led Patient-Focused Drug Development Meetings (slideshow)
- Provides context on externally led PFDD meetings
- Externally-led Patient-Focused Drug Development Meetings (webpage)
- Homepage for externally led PFDD meetings
- Guidelines for Developing a Letter of Intent (LOI) for Externally-Led Patient Focused Drug Development Meetings (PDF)
- PFDD: Disease Area Meetings Held in Fiscal Years 2013-2017 (webpage database)
- A list of FDA led PFDD meetings
- External Resources or Information Related to Patients’ Experience (webpage with links)
- Includes a list of externally led PFDD meeting reports; draft guidances for collecting patient experience data; and natural history studies for conditions
- FDA’s internal Voice of the Patient Reports (webpage database)