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Participate In FDA Advisory Committee Meetings

Providing Testimony

As mentioned previously, FDA Ad Comm meetings provide 2 ways for members of the public, including patients, patient advocates, caregivers, and medical professionals involved in the care of patients, to provide information to the Committee to be considered during their discussions and recommendations to the FDA. Both are highly valued and can be a way for your patient community’s voice to be heard at a critical time in the regulatory decision making process. 

  • Written testimony: Copies of all written testimony are distributed to the members of the committee prior to the meeting. 
    • One of the advantages of written testimony is the provided information can be referenced repeatedly by the committee members. 
    • Written testimony can be submitted by those who:
      • Cannot attend the meeting.
      • Plan on attending the meeting.
      • Will be also presenting oral testimony.
      • Are from outside the United States.
    • The meeting announcement in the Federal Register will include the details required to submit written testimony, including
      • The FDA staff receiving the submissions.
      • The deadline for submissions to be included in the meeting.
      • Email address, mailing address, and FAX number for submission. 
  • Oral testimony: The impact of your patient community’s voice speaking directly to committee members, as well as the FDA staff attending the meeting, can be powerful.
    • One of the advantages of oral testimony is allowing the committee members to put faces to the patients, families, and clinicians affected by the final decision of the FDA.
    • To during the open public hearing, interested persons need to contact the designated FDA staff by the deadline in the Federal Register announcement. Contact should include:
      • Name and contact information of the person wishing to provide testimony.
        • If representing a group, then the spokesperson’s name and contact information, name of group, population represented by group, and mission statement of group.
      • A brief statement or outline of the general nature of the evidence or arguments the person wishes to present.
      • The approximate amount of time requested to make your presentation (usual allotment is between 5 to 10 minutes, but is dependent on the number of presentations and the information being presented).
    • A confirmation will be sent to individuals indicating that their testimony will be among those included during the Open Public Hearing. 
      • Allotted time for an individual’s oral testimony is usually included in the confirmation.
      • In rare instances where public demand is high, the FDA may opt to implement a lottery and randomly select from among the requests to speak.
      • To allow more speakers, individuals with similar evidence or arguments may be asked to group their presentation into one.
      • FDA may decline a request to speak at an Open Public Hearing if the person wishes to address a matter that is unrelated to the advisory committee’s work. 
    • After acceptance, if the presenter would like to use slides or videos during their presentation, they should inform the designated FDA staff to determine the best format to be used.
      • All videos or slides should be sent at least a week prior to the FDA Ad Comm so that playability can be ensured and corrected if there are any technical issues.
      • Due to software security concerns, videos or slides will not be accepted on a thumb drive the day of the FDA Ad Comm meeting.
    • When arriving on the day of the FDA Ad Comm meeting, designated speakers should identify themselves to FDA staff members and provide the staff with any handouts or other materials for distribution to committee members, and be included in the meeting’s permanent record.
      • A table will be made available near the registration desk for any printed materials you wish to make available to those attending the meeting.
    • Designated speakers will be assigned a number to establish order of speakers.
    • Special seating is usually reserved for registered speakers from the public.
    • Those who speak are encouraged to disclose any financial relationships they may have with the topic of the meeting or with the sponsors or competitors of the therapies under discussion.
    • After a person has made their statement, the FDA Ad Comm members may ask the person questions.
    • The Open Public Hearing most often is held the hour after the lunch break. 
    • For more details, you may wish to review the FDA Guidance: The Open Public Hearing at FDA Advisory Committee Meetings
    • The FDA also provides a more public friendly version of the Guidance, which summarizes steps to becoming a designated speaker and some tips for speaking: Guidelines for Speakers at the Open Public Hearing of an FDA Advisory Committee Meeting
  • Testimony content: 
    • Clinical trial participants (and their guardians, if the child is a minor) and physicians involved in the clinical trial should consult the agreement signed with the Sponsor of the therapy clinical trial prior to providing written or oral testimony. 
      • In some cases, there may be limitations on what can be shared.
      • The FDA Ad Comm meeting does not nullify the signed agreement.
    • Limit the amount of general statistics and data that is provided. 
      • For example, in most cases the committee members will already be aware of how many people have the disease.
      • Depending on the concerns of the particular therapy, you or a member of your Scientific/Medical Advisory Board may wish to present data that you wish to be considered in the decision in either written or oral testimony rather than being presented by multiple members of your patient community.
    • Encourage members of your patient community and associated clinicians to share their direct experience with the symptoms being targeted by the current therapy. For example, discuss the impact of: 
      • Targeted symptom(s) on quality of life and daily living, including not only patients, but also family and friends.
      • Current treatment option(s). For example the current treatment option:
        • May not be effective for most.
        • Is difficult to administer.
        • Has multiple or serious adverse effects.
      • The potential of the investigational therapy to improve quality of life and daily living.
    • Share specific, personal experiences that demonstrate the impact of symptom(s), disease, and/or an investigational therapy rather than general statements. 
    • Describe the hopes and dreams of the patient community and how this medical treatment may be a step towards realizing those dreams. 
    • Consider grouping individual oral testimonies that are similar together and be presented by 1 speaker
      • The FDA Ad Comm may make this request if there are many speakers wishing to provide oral testimony.
      • Grouping similar testimonies allows more time for different aspects or perspectives to be presented.
      • One person speaking for multiple patients or families can actually have a greater impact, then each individual presenting a similar story. 
      • The spokesperson can name the other patients/families or state how many patients/families they are representing.
      • Each person or family can still provide written testimony.

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)