FDA seeks new members for Patient Engagement Collaborative

Regulatory NewsRegulatory News | 23 July 2021 |  By 

The US Food and Drug Administration is seeking eight new members for its Patient Engagement Collaborative (PEC), a group charged with gaining meaningful patient input into medical product development and regulatory decision making.
The 16-member panel includes patients, caregivers, and advocates who serve for 2 to 3 years. The panel is a joint effort between FDA and the Clinical Trials Transformation Initiative. Panel members are expected to participate in two to four meetings (either virtually or in person) each year, as well as monthly teleconferences. Current members of the panel include patients with a cross-section of medical conditions including rare disorders, cancer, sickle cell disease, neurological conditions, transplant recipients, and patients with chronic pain.
The application period for the PEC is open through 23 August 2021. The new PEC members will be chosen by a committee of patient advocates and staff from FDA and the Clinical Trials Transformation Initiative.
“The PEC is a forum for patients’ voices to be heard and to advocate for patients who are seeking different health outcomes,” Stephanie Caccomo, FDA media relations director, told Focus. “The FDA listens closely to feedback from individuals in the PEC and uses the insight from patients to inform regulatory decision making.”
In the past, the PEC has worked on creating new ways to collaborate with patient communities, making interactions with patients more systematic, and improving transparency and communication between FDA and patient communities. Recently, the group has been active around COVID-19, working to understand the pandemic’s impact on clinical trial progress in other diseases and to elevate patient concerns surrounding COVID-19 vaccines, according to an FDA Voices article.
In July 2021, the PEC members held a virtual meeting with the European Medicines Agency (EMA) Patients and Consumers Working Party to exchange ideas about involving patients in regulatory decision making and in incorporating perspectives from young patients.
The Crohn’s & Colitis Foundation, which submitted a nomination of the PEC in 2018, praised the group and FDA’s efforts to bolster patient involvement with the agency. “Patient engagement is critical in medical product development; particularly in improving clinical trial design, expanding label indications to communities in need using real world evidence, and supporting patient uptake of biosimilars,” said Sarah Buchanan, director of advocacy for the Crohn’s & Colitis Foundation.
The PEC, which was launched in 2018, is part of a portfolio of patient engagement opportunities through FDA that includes patient listening sessions; the Patient Representative Program, which allows patients to offer input as temporary government employees; the Patient-Focused Drug Development Initiative at the agency’s Center for Drug Evaluation and Research (CDER); the Patient Engagement Advisory Committee at the agency’s Center for Devices and Radiological Health (CDRH); and CDRH’s Patient & Caregiver Connection program (RELATED: FDA Holds First Patient Engagement Advisory Committee Meeting, Regulatory Focus 12 October 2017).
Interested applicants are encouraged to submit a curriculum vitae or resume and a letter of endorsement, and to complete an online form available at https://duke.qualtrics.com/jfe/form/SV_eLDSvmVIXdsAdVP. Applicants who are unable to submit materials electronically should call FDA’s Office of Patient Affairs at 301-796-8460 to arrange for mail submission.
Federal Register notice


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