Participate In FDA Advisory Committee Meetings

Tips for Success

If it is likely that there may be an FDA Ad Comm meeting scheduled for a therapy related to your disease, determine the best way to help educate your patient group and network of clinicians about the process and how they can participate. Consider:
- Holding and then posting webinars.
- Developing websites to host FAQs or infographs.
- Mailing FAQs or other styles of information is especially important if members of your community do not have internet access in their home.
- Providing reliable resources for those wishing to learn more details.
- Determining the best way to notify your community when a meeting is announced.
Patient Project Muscular Dystrophy has three very informative resources to help you learn more details about FDA Ad Comm meetings and how to submit testimonies. You may wish to adapt their webpages to address your own patient group.
- What is an Ad Comm? is a videorecording of a September 2015 webinar presented to the Duchenne muscular dystrophy (DMD) patient population in preparation of 2 upcoming FDA Ad Comm Meetings.
  - The presenters are 3 staff members of the FDA.
  - The video is just over 1 hour long.
- FDA Advisory Committee Meetings: An Overview of the Process & Ways to be Involved is a page on the group’s website summarizing information from the webinar that applied to the submission of written and oral testimonies.
  - The webpage answers several common questions.
- Details & Guidance on Submitting Written Testimony to the FDA Advisory Committee – PPMD provides suggestions for the type of information that may be most helpful to include. Although specific to the Duchenne muscular dystrophy community, many of the suggestions apply to any rare disease community.
The FDA also provides several resources that include more details about the FDA Ad Comms and meeting process:
- Learn About FDA Advisory Committees is written by the FDA Patient Affairs staff, and provides an overview in question and answer format mainly free of technical and legal jargon.
- Advisory Committees: Critical to the FDA’s Product Review Process is provided as part of Drug Information for Consumers. In a short essay style, the focus is mainly on the types of members and the purpose of the meetings.
- Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings
Familiarize members of your patient community who will be attending the meeting with what to expect and what is expected of them.
- The FDA provides clear guidance that can be shared with your community: Public Conduct During FDA Advisory Committee Meetings
- Understanding the reasoning behind some of the rules can also be helpful. For example, members on the FDA Ad Comm are not permitted to speak with the audience, even those presenting testimony, about information pertaining to the therapy during breaks or prior to or after the meeting, because the information in the meeting is meant to be public.
- Questions from the audience can only be asked if acknowledged by the Chairperson. In most cases, due to the amount of information being presented and the time needed for discussions among the FDA Ad Comm members, the time for the questions is very limited.
Reaching out to other patient groups who have participated in FDA Ad Comm meetings can help you learn other approaches and what they felt did and did not work.

Resources

FDA Ad Comm Meeting

FDA For Patients Website U. S. Food and Drug Administration (FDA) (link)

Members of an FDA Ad Comm

Applying for Membership on FDA Advisory Committees U. S. Food and Drug Administration (FDA) (link)

Consumer Representatives on FDA Advisory Committees U. S. Food and Drug Administration (FDA) (link)

About the FDA Patient Representative Program U. S. Food and Drug Administration (FDA) (link)

How to Apply to the FDA Patient Representative Program U. S. Food and Drug Administration (FDA) (link)

Providing Testimony

Guidance: The Open Public Hearing at FDA Advisory Committee Meetings U. S. Food and Drug Administration (FDA) (link)

Guidelines for Speakers at the Open Public Hearing of an FDA Advisory Committee Meeting U. S. Food and Drug Administration (FDA) (link)

Tips for Success

What is an Ad Comm? Videorecording Patient Project Muscular Dystrophy (link)

FDA Advisory Committee Meetings: An Overview of the Process & Ways to be Involved Patient Project Muscular Dystrophy (link)

Details & Guidance on Submitting Written Testimony to the FDA Advisory Committee – PPMD Patient Project Muscular Dystrophy (link)

Learn About FDA Advisory Committees U. S. Food and Drug Administration (FDA) (link)

Advisory Committees: Critical to the FDA's Product Review Process U. S. Food and Drug Administration (FDA) (link)

The Open Public Hearing at FDA Advisory Committee Meetings U. S. Food and Drug Administration (FDA) (link)

Public Conduct During FDA Advisory Committee Meetings U. S. Food and Drug Administration (FDA) (link)