In 2017, patient communities commented in public feedback 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’s (EMA) Patients’ and Consumers’ Working Party. The PEC is facilitated by federal law 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
• 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.

See CTTI’s Patient Engagement Collaborative page for a full member list and more information about the PEC.

Following an official call for applications, a selection committee consisting of patient advocates, staff from CTTI and the FDA chooses individuals to serve as PEC members. CTTI and the FDA ensure involvement of representatives with a variety of perspectives including patients, caregivers and diverse representatives from patient organizations. PEC members are expected to serve for two to three years.