The PEC was established by the FDA and the Clinical Trials Transformation Initiative (CTTI). The inaugural PEC meeting was held in August 2018. The PEC is a group of patient organizations and individual representatives who discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions at the FDA. The PEC is coordinated by the FDA’s Office of Patient Affairs (OPA) in the Office of the Commissioner.

The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership that brings together organizations and individuals representing academia, clinical investigators, government and regulatory agencies, industry, institutional review boards, patient advocacy groups, and others, to develop evidence-based solutions to clinical research challenges. The FDA and CTTI are currently collaborating on the PEC.

In 2017, patient communities commented in public feedback on the FDA's Safety and Innovation Act (FDASIA), section 1137, Patient Participation in Medical Product Discussions, to create an outside group to provide input on patient engagement across the agency. In response to that feedback and with help from patient organization representatives, the FDA and CTTI established the PEC. The PEC was modeled after the European Medicines Agency (EMA)’s Patients’ and Consumers’ Working Party. The PEC is also facilitated by provisions in both the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017 to foster patient participation and incorporate patient experiences in the regulatory process.

The PEC is 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
• improving transparency
• enhancing communication tools between the FDA and patient community
• developing educational tools on the medical product regulatory process.

Representatives from the patient community who 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 CTTI and the FDA (staff from multiple medical product centers) chooses individuals to serve as PEC members. CTTI and the FDA ensures involvement of representatives with a variety of perspectives and inclusion of patients, caregivers, and representatives from a diversity of patient organizations. PEC members are expected to serve for a total of 2 to 3 years.