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Participate In FDA Advisory Committee Meetings

FDA Ad Comm Meeting

An FDA Ad Comm reviews and evaluates data concerning the safety and effectiveness of investigational and marketed therapies, including drugs, biologics, and medical devices. Understanding when an FDA Ad Comm is utilized as well as its purpose and procedure can help you determine how your group can participate.

  • Convening an FDA Ad Comm meeting: Not every therapy’s approval or post approval process utilizes an FDA Ad Comm meeting. 
    • FDA Ad Comm is typically not utilized when the data clearly support or clearly does not support the safety and effectiveness of the therapy under investigation.
    • FDA Ad Comm may be convened when: 
      • The interpretation of the data does not support a clear approval or disapproval decision.
      • The benefit/risk analysis does not support a clear decision.
      • There are concerns about the data presentation or difficulties interpreting the data.  
      • The data may warrant special warnings or precautions added to labels to make the therapy safer or easier to use.
      • Postmarket surveillance data may support safety updates or an approved therapy from being pulled from the market. 
    • Meetings can occur at any stage of the FDA marketing review process, including postmarket. 
    • The decision to involve an FDA Ad Comm is usually at the discretion of the division director in 1 of the FDA’s 5 therapy centers.
    • The FDA Ad Comm only makes recommendations to the FDA; the FDA makes the final decision. 
    • The discussions and points being raised during the FDA Ad Comm meeting provides valuable insight to the FDA.
  • FDA Ad Comm meeting: Because an FDA Ad Comm is made up of experts from outside the FDA, meetings allow the FDA to include a variety of perspectives for consideration when making the final marketing decision for a therapy under investigation. As noted above, FDA Ad Comm can also be used when there are postmarket concerns. 
    • Meetings typically last 1 day starting at 8am ET with a minimum of 1 hour set aside for oral testimonies from the patient community and other stakeholders. 
      • If not enough people registered to speak, the time allotted for testimonies may be less.
      • If the number of applicants for attendees wishing to speak is large, the time may be increased at the discretion of the Chair
      • A meeting may be scheduled for more than 1 day depending on the time needed for oral testimonies and other material and information being presented. 
    • Agenda for the meeting usually includes the following items, although the order of the items may vary:
      • Introduction
      • Conflicts of Interest of any of the FDA Ad Comm members
      • Presentation by Sponsor
      • Presentation by FDA
      • Open public hearing (period of oral testimony)
      • FDAs questions for FDA Ad Comm
      • Committee discussion and deliberation
      • Vote and discussion.
    • Meetings include FDA staff, FDA Ad Comm Committee members, and the Sponsor and are open to the public. Public meetings provide a transparent process:
      • Registration may not be required unless you plan to speak during the Open Public Hearing portion of a meeting. However if it is required, a link to do so is provided with the public announcement. 
      • A closed session to discuss trade secrets may be granted during the meeting at the discretion of the Chair. 
        • Closed sessions are clearly indicated on the agenda, which is available prior to the meeting. 
      • The FDA Ad Comm allows public access to proprietary background information and data from clinical trials or postmarket surveillance.
        •  Because this type of information is owned by the Sponsor, this may be the only opportunity to do so. 
      • The meeting permits the public to view the complexity of the approval decision making process including the weighing of benefit/risks.
      • FDA Ad Comm provides 2 different avenues for comments from the patient community to be submitted to the committee. 
        • Written submissions.
        • Oral presentations.
        • Exceptions for specific patient communities have been made that allow for submission of video recordings of comments in the place of written submissions.
        • Presentations by Skype or other telecommunication software are not permitted. 
      • If the meeting is held on the FDA campus, the meeting will be webcast.
        • The webcast is not interactive. 
          • For example, there is no opportunity for those viewing the meeting to ask questions.
        • Recordings of webcast meetings are made available to the public after the meeting.
      • If the meeting is off campus, patient groups or other sources may offer webcasting or recordings.
        • Outside sources may charge a fee for viewing the webcast or recording. 
  • Specific Committees: Learning about the different committees can help you better understand which committee(s) may be important to your disease. 
  • Meeting announcements: Being engaged with Sponsors and the FDA staff prior to and during clinical trials studying therapies for your disease is the best way for you to learn when the FDA decides to convene an FDA Ad Comm meeting. However there are several resources that may be helpful to your patient community once a meeting has been announced.
    • FDA is required to publish announcements of advisory committee meetings at least 15 calendar days before the meeting date in the Federal Register . 
    • Once a meeting is published in the Federal Register, it is posted on FDA’s Ad Comm meeting calendar, which can be found on the Advisory Committee Calendar page.
    • FDA has a website, For Patients ,  specifically designed for patients and patient groups, which includes links to more information about the FDA Ad Comm and the calendar of public meetings. 
    • Questions about upcoming FDA Ad Comm meetings can be addressed to:
    • The FDA Ad Comm meeting announcements include: 
      • Date(s)
      • Times
      • Location
      • Topic of discussion
      • Weblinks for further information
      • Instructions and contacts for written or in-person comments from the public

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)