Participate In FDA Advisory Committee Meetings

Overview

U.S. Food and Drug Administration Advisory Committee (FDA Ad Comm) meetings are open to the public. You and your patient community can take part in these meetings by submitting oral or written testimony or attending as an audience member. Your comments may include advising the FDA about benefits or risks of an investigational therapy or discussing the impact of living with your disease.

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

Members of an FDA Ad Comm

An FDA Ad Comm ordinarily consists of 10 to 15 fixed or “standing” members including the chairperson. Members are selected because they possess expertise specific to the committee’s function. Most committees will also have a consumer representative and an industry representative. FDA Patient Representatives and expert consultants are often added as temporary voting members.

  • Scientific members
    • Physician-scientists whose specialties or research involves the kinds of therapies being reviewed, including: 
      • Statisticians
      • Epidemiologists
      • Medical faculty
      • Chemists
      • Biologists
      • Engineers
      • Nutritionists
      • Toxicologists
      • Experts in preclinical (animal) studies
    • As core members of FDA Ad Comms, responsibilities will not be limited to a single disease or a specific therapy of interest. However members of your Scientific/Medical Advisory Board may be interested in learning more about the opportunity:
  • Industry representatives:
    • Address global concerns for industry, not their specific employer.
    • Are not the industry Sponsor for the therapy being reviewed.
    • May or may not have the ability to vote, depending on the specific committee.
  • Consumer representatives:
    • Offer broad knowledge of consumer rights and needs.
    • Have an affiliation with and/or active participation in consumer or community-based organizations.
    • Consumer representatives are core members and therefore are not focused on a single disease or specifictherapy. However, the FDA does provide more information about applying to be a consumer representative if you or someone you know is interested:
  • FDA Patient Representatives:
    • FDA Patient Representatives are recruited and then specially trained to participate as temporary voting members for FDA Ad Comm meetings and to provide input earlier in the regulatory therapy development and review process by engaging directly with Division review staff. 
    • They are appointed as Special Government Employees (temporary employees) to provide direct input to agency staff as they share valuable insight on their experiences with various diseases, conditions, and devices while gaining access to confidential information.
    • Qualifications include:
      • Personal experience with the disease either as a patient or primary caregiver.
      • Ability to be objective while representing the concerns of others in their communities.
      • Willingness and ability to communicate in public their views and perspectives.
      • Knowledge about most treatment options and research for the areas of experience they are representing.
      • Impartiality with minimal to no financial conflicts of interest or ethical issues for self or close family members, for example, a financial interest, such as stock, in companies that may be affected by FDA decisions.
    • FDA Patient Representatives are added to the FDA Ad Comm panel for a meeting when a therapy concerns their disease or a disease within their area of expertise.
    • Due to the required training, you or a member of your patient community cannot apply to be a Patient Representative for an already scheduled or soon to be scheduled FDA Ad Comm meeting for a therapy for your disorder. 
    • The FDA provides more information about FDA Patient Representatives including how to apply.
  • Consultants: Scientists or medical personnel whose expertise is not represented by the fixed voting membership may be added to an FDA Ad Comm.
    • World experts on the topic being discussed are often added as temporary voting members.
    • These experts are present only for special meetings.
    • Members of your Scientific/Medical Advisory Board may meet the qualifications to be a consultant if there is no conflict of interest.

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 side 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.

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.
  • The FDA also provides several resources that include more details about the FDA Ad Comms and meeting process:
  • 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
For Patients FDA 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 Adminstration (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
Tips for Success
What is an Ad Comm? Videorecording Patient Project Muscular Dystrophy (link)
Learn About FDA Advisory Committees 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)

U.S. Food and Drug Administration Advisory Committee (FDA Ad Comm) meetings are open to the public. You and your patient community can take part in these meetings by submitting oral or written testimony or attending as an audience member. Your comments may include advising the FDA about benefits or risks of an investigational therapy or discussing the impact of living with your disease.

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

An FDA Ad Comm ordinarily consists of 10 to 15 fixed or “standing” members including the chairperson. Members are selected because they possess expertise specific to the committee’s function. Most committees will also have a consumer representative and an industry representative. FDA Patient Representatives and expert consultants are often added as temporary voting members.

  • Scientific members
    • Physician-scientists whose specialties or research involves the kinds of therapies being reviewed, including: 
      • Statisticians
      • Epidemiologists
      • Medical faculty
      • Chemists
      • Biologists
      • Engineers
      • Nutritionists
      • Toxicologists
      • Experts in preclinical (animal) studies
    • As core members of FDA Ad Comms, responsibilities will not be limited to a single disease or a specific therapy of interest. However members of your Scientific/Medical Advisory Board may be interested in learning more about the opportunity:
  • Industry representatives:
    • Address global concerns for industry, not their specific employer.
    • Are not the industry Sponsor for the therapy being reviewed.
    • May or may not have the ability to vote, depending on the specific committee.
  • Consumer representatives:
    • Offer broad knowledge of consumer rights and needs.
    • Have an affiliation with and/or active participation in consumer or community-based organizations.
    • Consumer representatives are core members and therefore are not focused on a single disease or specifictherapy. However, the FDA does provide more information about applying to be a consumer representative if you or someone you know is interested:
  • FDA Patient Representatives:
    • FDA Patient Representatives are recruited and then specially trained to participate as temporary voting members for FDA Ad Comm meetings and to provide input earlier in the regulatory therapy development and review process by engaging directly with Division review staff. 
    • They are appointed as Special Government Employees (temporary employees) to provide direct input to agency staff as they share valuable insight on their experiences with various diseases, conditions, and devices while gaining access to confidential information.
    • Qualifications include:
      • Personal experience with the disease either as a patient or primary caregiver.
      • Ability to be objective while representing the concerns of others in their communities.
      • Willingness and ability to communicate in public their views and perspectives.
      • Knowledge about most treatment options and research for the areas of experience they are representing.
      • Impartiality with minimal to no financial conflicts of interest or ethical issues for self or close family members, for example, a financial interest, such as stock, in companies that may be affected by FDA decisions.
    • FDA Patient Representatives are added to the FDA Ad Comm panel for a meeting when a therapy concerns their disease or a disease within their area of expertise.
    • Due to the required training, you or a member of your patient community cannot apply to be a Patient Representative for an already scheduled or soon to be scheduled FDA Ad Comm meeting for a therapy for your disorder. 
    • The FDA provides more information about FDA Patient Representatives including how to apply.
  • Consultants: Scientists or medical personnel whose expertise is not represented by the fixed voting membership may be added to an FDA Ad Comm.
    • World experts on the topic being discussed are often added as temporary voting members.
    • These experts are present only for special meetings.
    • Members of your Scientific/Medical Advisory Board may meet the qualifications to be a consultant if there is no conflict of interest.

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 side 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.
  • 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.
  • The FDA also provides several resources that include more details about the FDA Ad Comms and meeting process:
  • 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
For Patients FDA 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 Adminstration (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
Tips for Success
What is an Ad Comm? Videorecording Patient Project Muscular Dystrophy (link)
Learn About FDA Advisory Committees 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)