Reasons an FDA Patient Listening Session Request May Not Move Forward
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Why your Patient Listening Session request may not move forward?
If your meeting request is not moving forward, it does not mean that the FDA is not interested in hearing from you or your community. Here are some common reasons that a meeting may not move forward:
- The meeting request was incomplete or did not provide enough information, such as:
- Missing agenda
- Unclear/missing meeting topics or goals
- The meeting topic(s) that are outside the scope of the agency’s mission and/or Patient Listening Session program. Some examples are:
- Specific ongoing clinical trials
- Investigational drugs, biologics or medical devices, which are products that have not yet been approved or cleared by the FDA and the FDA has not found these products to be safe and effective for their specific use.
- Meeting to promote or reverse a regulatory decision
- Meeting topics that are too general or too narrow, such as:
- Healthcare costs:
- Cost or price of treatments, such as drugs, medications or medical devices
- Concerns related to your health insurance, such as lack of coverage
- Health care provider/facility quality:
- Complaints or concerns about the care you have received from a doctor, medical/health provider, or a health care facility (like a hospital)
- Suggestions about health care provider education or training
- Concerns about your health care provider's experience or license
- Lack of specialists who treat or know about your disease or condition
- Healthcare costs:
- The meeting request was similar to a previous meeting held (same topics, goals or agenda).
- The meeting request may not align with agency regulatory priorities or current public health needs.
- A Patient Listening Session may not be the appropriate type of meeting. The meeting request may already align with a similar meeting in the planning process, such as a Patient-Focused Drug Development (PFDD) meeting or a Critical Path Innovation Meeting (CPIM).
What are the next steps?
- Contact the Public Engagement Staff to see if any changes can be made to your meeting request, so it can move forward, such as:
- Request a different type of meeting, such as a Patient-Focused Drug Development (PFDD) meeting or a Critical Path Innovation Meeting (CPIM).
- Submit any missing information, such as meeting topics, goals and agenda.
- Make changes if needed, such as revising your meeting request and/or the timing of your meeting request.
- Adjust meeting goals and topics to fall under the FDA's regulatory authority. For more information, please visit What does FDA regulate?
- Resubmit your meeting request at a later time (e.g., a year).
- Review your topics and goals for the proposed meeting and adjust your meeting audience accordingly.
- Hold a meeting on your own. The FDA encourages you to:
- Consider conducting your own meeting on topics of importance to your organization/community.
- Continue communicating with interested parties, such as medical product developers or researchers.
- Consider inviting FDA staff to attend your meeting by contact the Office of External Affairs at FDASpeaks@fda.hhs.gov.
- The FDA will determine its level of involvement on a case-by-case basis, taking into account a number of factors. For example, an identified need for a better understanding of the patient perspective on the particular topic, proposed meeting details, FDA staff capacity, and resource availability.
- Review the Contacts for Requesting an FDA Speaker and FDA/CBER Speaker Request/Invitation webpages if you would like to request an FDA speaker for your meeting.
- Stay in contact with the FDA Public Engagement Staff about future engagement opportunities for your patient community.