As the FDA continues to advance its patient engagement efforts, it is important that an ongoing forum exists to discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions.
Acknowledging the needs and concerns of patients, caregivers, and advocates, the FDA continues to identify ways to better serve the patient community. The FDA, together with the Clinical Trials Transformation Initiative, established a group of patient organization and individual representatives to discuss topics focusing on enhancing patient engagement in medical product development and regulatory discussions at FDA. The Patient Engagement Collaborative (PEC) is another advancement in FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Patient Affairs Staff (PAS) in the Office of Medical Products and Tobacco (OMPT).
Patient Engagement Collaborative Establishment
Patient communities and other stakeholders commented in public feedback on Food and Drug Administration Safety and Innovation Act (FDASIA), section 1137, Patient Participation in Medical Product Discussions, to create an outside group that provides input on patient engagement across the agency. In response to that feedback, FDA and CTTI established this Collaborative with help from patient organization representatives, which was modeled after the European Medicines Agency (EMA)’s Patients’ and Consumers’ Working Party.
This Collaborative is also facilitated by provisions in both the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017. Both provisions aim to foster patient participation and incorporate patient experiences in the regulatory process.
The PEC will provide an ongoing forum to discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions. Discussion topics may include:
creating new models for patients to collaborate as partners in the medical product development and regulatory review process
making patient engagement more systematic
enhancing communication tools between the FDA and patient community
developing educational tools on the medical product regulatory process.
Representatives from the patient community to participate in the PEC include:
Patients who have personal disease experience.
Caregivers who have personal experience supporting someone with a health condition. A caregiver can be a parent, child, partner, family member, or friend.
Representatives from patient groups who, through their role in the patient group, have direct or indirect disease experience.
Following an official call for nominations, a selection committee consisting of patient advocates, staff from the Clinical Trials Transformation Initiative, and FDA staff from multiple medical product centers, has chosen the following 16 individuals to serve as the first slate of PEC members. A great deal of emphasis was placed on ensuring involvement of representatives with a variety of perspectives and inclusion of patients, caregivers, and representatives from a diversity of patient organizations. Members are expected to serve for a total of 2 to 3 years with the inaugural meeting being held on August 2018.
|PEC Member List|
|Adrienne Shapiro||Lawrence "Rick" Phillips|
|Anne Hall||Lynne Quittell|
|Christine Brown||Melissa Hogan|
|Dave White||Nancy Lenfestey|
|Dawn Aldrich||Philip Posner|
|Elizabeth Joniak-Grant||Ronald Bartek|
|Isabelle Lousada||Stephanie Monroe|
|Jeffrey Goldstein||Theresa Strong|
Patient Engagement Collaborative Meeting Summaries
March 20, 2019 - Patient Engagement Collaborative Meeting
August 29, 2018 - Inaugural Patient Engagement Collaborative Meeting
For more information about the Patient Engagement Collaborative, email the Patient Affairs Staff at PatientAffairs@fda.hhs.gov.