SMG 9006 (05/10/2022) 1

SMG 9006

FDA Staff Manual Guides, Volume IV – Agency Program Directives

General or Multidiscipline

Patient Affairs FDA Patient Listening Sessions

Effective Date: May 10, 2022

1. Purpose

2. Background

3. Responsibilities

4. Procedures

5. Effective Date

6. History

1. Purpose.

The purpose of this document is to describe the procedures for the management of 

cross-Center FDA Patient Listening Sessions (PLS) led by Patient Affairs in the 

Office of Clinical Policy and Programs (OCPP) in the Office of the Commissioner 

(OC). Cross-Center refers to sessions that involve more than one Center, typically to 

include the Center for Biologics Evaluation and Research (CBER), Center for Drug 

Evaluation and Research (CDER), Center for Devices and Radiological Health 

(CDRH) and OC. As needed, the Center for Food Safety and Applied Nutrition 

(CFSAN), Center for Tobacco Products (CTP), and others may be included. This 

Staff Manual Guide (SMG) outlines the standardized processes for cross-Center 

PLS, organized and executed by Patient Affairs, to enable efficient and effective 

planning for all internal and external stakeholders involved. 

2. Background.

FDA has made significant efforts to broaden its engagement with patients and 

ensure that patients and caregivers are actively engaged in the medical product

regulatory process, and their voice is considered as a part of FDA’s regulatory work. 

Several key programs across the medical product centers support patient-related 

mandates included in User Fees Acts (UFA) and the 21st Century Cures Act. The 

Patient Affairs PLS builds on these efforts. The Food Drug and Safety Innovation Act 

(FDASIA) and the fifth Prescription Drug User Fee Agreement (PDUFA V) enacted 

in 2012, directed FDA to develop and implement strategies to solicit the views of 

patients to inform medical product development and regulatory decision activities. 

The 21st Century Cures Act enacted in 2016, the sixth Prescription Drug User Fee 

Agreement (PDUFA VI), and the Medical Device User Fee Amendments (MDUFA) 

of 2017 built upon previous efforts by advancing the collecting, analyzing, 
SMG 9006 (05/10/2022) 2

interpreting, and integrating patient disease experiences into medical product 

development and regulatory decision-making processes. 

The Patient Affairs FDA PLS are one of several programs across the Agency that 

support these patient-related mandates. Through these sessions, the FDA staff have 

the opportunity to ask questions directly to patients and caregivers about their 

experience related to their health or a disease and/or condition. PLS provide a 

unique opportunity for the FDA to gain insight to patients’ perspectives on the 

burdens of a disease, current treatments if any, its impact on the patients’ and 

caregivers’ daily activities and quality of life, as well as ultimately what is important to 

patients when new products are to be developed. A key component of medical 

product review and regulation is shared learning and incorporating input directly from 

patients and/or caregivers. 

A PLS is a cross-Center, informal, non-binding meeting, (the meeting is herein 

referred to as a “Session”). The Sessions are generally not intended to be focused 

on a specific medical product. The Session is typically 60 or 90 minutes in length 

and are recommended to have no more than 7 patient perspectives participating in 

the Session1. The Sessions can either be requested by patients/advocates 

(externally) or by FDA (internally). External sessions are initiated by patients or 

advocate groups while internal Sessions are initiated by FDA staff who are looking to 

gain information from the patient community. These two types of Sessions are 

known as Patient-Led Listening Sessions and FDA-Requested Listening Sessions. 

Sessions are not open to the public however, high-level summary documents may 

be posted publicly online after the PLS has occurred. 

The goals of PLS include:

1. To educate FDA review staff about diseases, conditions, and health-related 

experiences and perspectives that are important to patients, caregivers, 

advocates, and community representatives;

2. To broaden FDA’s awareness of unmet patient needs and to better contextualize 

the patient experience;

3. To help the FDA better understand what is most important to different 

communities and individuals who have specific health, medical, and treatment 

needs;

4. To inform regulatory decision-making, e.g., for a specific product or application, 

benefit/risk trade-offs, developing guidances;

1 The FDA Patient Listening Sessions are exempt from the Paperwork Reduction Act (PRA) under 21st 

Century Cures Act Section 3003.
SMG 9006 (05/10/2022) 3

5. To help provide a starting point to guide or accelerate early-stage research and 

development, e.g., helping to identify endpoints and new outcome assessment 

tools; and

6. To help patients and their advocates understand the FDA’s mission and work, 

e.g., generating awareness around FDA’s role in the medical product 

development process and review.

Patient Affairs has developed, piloted, and refined standardized procedures for 

planning and executing a Session to ensure that they provide value while not adding 

excessive burden to FDA and patient stakeholders. Based on the outcomes of the 

pilot and the internal and external stakeholder feedback, the procedures were 

implemented and are outlined in this SMG. 

3. Responsibilities. 

A. Patient Affairs: Located in the Office of Clinical Policy and Programs in the 

Office of the Commissioner, the primary FDA staff responsible for executing PLS

that involve more than one Center.

B. Lead Review Division: The FDA division(s) with the primary interest in the PLS 

topic and who are typically an expert in the therapeutic area. 

C. Lead Division Point of Contact: An individual in the lead review division(s) who 

will serve as Patient Affairs’ main point of contact for planning FDA-requested 

PLS. 

D. Interested Staff and Divisions: FDA divisions other than the lead review 

division who have an interest in participating in the PLS in listening mode only. 

The Patient Engagement Leads from each Center assist with identifying 

interested staff and divisions.

E. Patient Engagement Lead: A Center representative who serves as Patient 

Affairs’ point of contact for their Center or program. 

F. Patient Community: The patients, caregivers, patient advocates, or community 

representatives encompassing the patient community who attend the PLS and 

provide insight into their experience and answer questions.

G. Patient Advocacy Group: The individual or groups of individuals who are 

patients, caregivers, or patient advocates who act as the representative for the 

patient community, when applicable. 

4. Procedures. 

The procedures for planning and executing a PLS in brief:
SMG 9006 (05/10/2022) 4

A. Evaluation

1. FDA staff or patients/advocacy groups submit a request for a FDA-Requested 

PLS or Patient-Led PLS, respectively, to Patient Affairs. The request should 

include:

a. Disease/condition name or issue relevant to a specific community

b. Desired meeting goals and objectives

c. Listening session topics or discussion questions 

d. Proposed draft agenda 

2. Patient Affairs reviews the request and considers whether a PLS is the 

appropriate avenue for communication between review staff and patients, 

caregivers, or their advocates. Some of the criteria used by Patient Affairs to 

accept and prioritize a request include:

a. No prior interactions and no currently planned interactions with the FDA 

on the same set of agenda topics 

b. Anticipated broad impact from the Session (e.g., Session will be attended 

by staff from two or more Centers)

c. Reviewing division verifies that the Session will aid in regulatory decisionmaking at that time

d. There is not another avenue that could better meet needs of the request

3. Patient Affairs engages relevant stakeholders, including the lead review 

division, patient engagement leads, interested staff and divisions, and the 

patient community to solicit additional context or feedback that can help clarify 

the appropriateness of the Session. 

a. Patient Affairs, in consultation with the review divisions, decides if a 

Session should be scheduled. Patient Affairs informs the requester 

whether a Session is appropriate and potential next steps. If not 

appropriate or an alternative avenue preferred: (I) Patient Affairs directs 

the requester to an alternative contact, (ii) suggests alternative timing, (iii) 

provides feedback that would enhance the appropriateness of request, or

(iv) provides feedback about the reason for the request being 

declined/turned down.

B. Preparation 

1. Requester refines the agenda and participant criteria. 
SMG 9006 (05/10/2022) 5

2. Patient Affairs hosts preliminary call(s) with the requestor as appropriate. 

Preliminary calls may occur with relevant FDA staff and/or the patient 

community. Preliminary calls will:

b. Help orient stakeholders to the logistics associated with organizing and 

running a Session

c. Develop or refine the agenda and, when applicable, define the participant 

selection criteria

d. Create a facilitation plan for the Session, including what questions or 

topics will be addressed and their intent 

Preliminary calls can occur at different stages of planning with attendance 

determined based on necessity and availability. 

3. Patient Affairs schedules a date and time for the Session and sends 

invitations to all pertinent stakeholders.

a. Patient Affairs provides materials to aide in the preparation for the 

Session, which could include expectations documents, logistics details, 

and a refined agenda or discussion questions. 

b. As necessary, Patient Affairs schedules additional preliminary calls to 

refine details of the Session. 

4. Patient Affairs and/or the patient community or patient advocacy group 

identify potential patients/caregivers to participate. 

a. For Patient-Led PLS, the patient community or advocacy group identifies

patients/caregivers to participate in the Session. 

b. For FDA-Requested PLS, Patient Affairs will either identify the 

participants, or will work with advocacy groups to identify participants. 

Identification is often completed through a survey tool. 

5. For FDA-Requested PLS, the lead review division reviews the deidentified list 

of participants to better tailor their discussion questions. When there are more 

interested participants than slots available for the Session, the lead review 

division selects the deidentified participants based on the deidentified 

information they shared in the survey or other tool. 

6. Patient Affairs (FDA-Requested PLS) or the patient advocacy group (PatientLed PLS) reaches out to selected and waitlisted patients and/or caregivers via 

phone to 1.) share information about the Session, 2.) determine that the 

patient or caregiver has first-hand familiarity with the subject matter and 3.) 
SMG 9006 (05/10/2022) 6

confirm the willingness of the patient or caregiver to participate in the Session 

and share their personal experiences. Patient Affairs or the patient advocacy 

group addresses any questions or concerns the patient or caregiver may 

have.

7. Patient Affairs develops a facilitation guide for PLS. For FDA-Requested PLS, 

Patient Affairs collaborates with the requester to develop discussion prompts 

and questions, which will be asked to the patient/caregiver participants. For 

Patient-Led PLS, Patient Affairs works with the requester to ensure their 

planned presentation and agenda will meet the needs of FDA attendees and 

the objectives of the PLS. Information commonly requested by FDA staff 

includes but is not limited to willingness to participate in clinical trials, the 

most meaningful symptom/disease improvement, the level of risk patients are 

willing to assume, and barriers to clinical trial participation. 

8. Patient Affairs manages logistics, including identifying a Session date and 

time, scheduling the meeting, and when applicable, reserving a conference 

room and providing directions to people coming to campus. Patient Affairs

distributes background documents and agendas to attendees prior to the 

session. Sessions typically are scheduled for either 60 or 90 minutes, 

depending on the number of participants and level of detail required to 

achieve the objectives of the Session.

C. Listening Session 

1. All participants dial-in via phone, connect to the meeting via Zoom, or arrive in 

person. Patient Affairs escorts non-FDA in-person attendees for the duration 

of their visit on FDA’s campus.

2. Patient Affairs opens the conference call line at least ten minutes early and 

monitors it as participants enter the Session. Patient Affairs ensures all lead 

review division and patient/caregiver participants attendees have joined and 

can hear/be heard. 

3. Patient Affairs initiates the Session with opening remarks. These include:

a. Patient Affairs introducing the meeting facilitators and explaining if and 

why “silent observers” are present

b. Explaining what PLS are, sharing the Session objectives, and setting 

attendee expectations

c. Reading a financial disclosure statement, and

d. Reading a disclaimer.
SMG 9006 (05/10/2022) 7

4. After Patient Affairs’ opening remarks, the PLS follows the prepared agenda 

and/or discussion prompts and questions.

a. In FDA-Requested PLS, Patient Affairs is the primary facilitator, and the 

lead division point of contact(s) are secondary facilitators. Patient Affairs

leads a discussion in which patients and caregivers are guided through a 

series of prepared questions. The lead division point of contact(s) ask 

follow on questions as needed. Patient Affairs is responsible for 

interjecting if the conversation deviates from the lead review division’s 

intended agenda and to ensure that all planned questions are asked to 

patient and/or caregiver attendees in the allotted Session time.

b. In Patient-Led PLS, the patients/advocates who requested the session are 

the primary facilitators and Patient Affairs are secondary facilitators. The 

patients/advocates present their planned remarks. After their remarks, 

approximately 15 minutes are allocated for an open discussion between 

the patient community and FDA. Patient Affairs facilitates the open 

discussion during which FDA staff are encouraged to ask questions. 

5. When there are approximately 5 minutes left, Patient Affairs provides closing 

remarks. Patient Affairs thanks the participants for their time, reviews next 

steps and action items, and concludes the Session.

D. Codification and Communication 

1. Patient Affairs thanks the patient community participants for their time via 

email. Patient Affairs collects feedback about the session and identifies 

procedural improvements via surveys sent to the patient community and FDA 

staff. 

2. As applicable, the lead review division and interested staff and divisions 

follow up on any outstanding questions that were raised during the Session 

and provide responses to Patient Affairs.

3. A summary document is developed, and a link is posted on FDA’s website.

a. In FDA-Requested PLS, Patient Affairs develops a high-level summary 

document that highlights the key takeaways discussed for each question 

asked to participants. The summary document is subsequently shared 

with the lead review division for their input and approval of the content. 

When approved, FDA posts the summary on FDA’s website. 

b. In Patient-Led PLS the patient community is encouraged to develop a 

high-level summary document that highlights the key takeaways 

discussed during the Session. Patient Affairs requests to review the 

summary before it is made available to the public and provides a 
SMG 9006 (05/10/2022) 8

disclaimer statement that should be included in the summary. FDA will 

post the link to the advocacy group’s summary on FDA’s website. 

5. Effective Date. 

The effective date of this guide is May 10, 2022.

6. Document History - SMG 9006, “Patient Affairs FDA Patient Listening 

Sessions”

Status 

(I, R, C)

Date 

Approved

Location of 

Change History Contact Approving Official

Initial 10/10/2019 N/A OC/OCPP/PAS Nina Hunter, Director, Office 

of Clinical Policy and 

Programs

Revision 05/05/2022 N/A.

OC/OCPP/Patient 

Affairs

Andrea Furia-Helms, 

Director, Office of Patient 

Affairs

Jodi Black, Director, Office of 

Clinical Policy and Programs

Back to Agency Program Directives, Volume IV (4000-9100)