The event marks a significant step in the agency’s efforts to broaden its engagement with patients.
The FDA held its first Patient Engagement Advisory Committee (PEAC) event as a significant step forward by regulators to strengthen the agency’s ties to patients and deepen their involvement in drug regulating activities.
The first advisory committee meeting gathered patients, caregivers and others who represent patients. Founded by the FDA’s Center for Devices and Radiological Health (CDRH), the meeting reflects the commitment to keep patients at the center of all work.
In the statement issued on October 11, FDA Commissioner Scott Gottlieb said: “CDRH is working with a diverse group of outside partners to encourage the inclusion of patient perspectives across the total medical device life cycle, from the design and ideation of the medical device to the clinical trial process and through the postmarket evaluation.” Gottlieb also noted that this includes new guidance on patient preference information for premarket approvals (PMAs), Humanitarian Device Exemption (HDE) applications, de novo requests, and inclusion in device labeling. “This guidance describes how patient tolerance for risk and perspective on benefit can be considered as part of the FDA’s assessment of the benefit-risk of certain devices,” he explained.
Gottlieb described the meeting as patient-focused to help the agency and its departments understand how to bring patient needs into the process and communicate with patients as individuals. “CDRH has also led the charge to integrate real world evidence into our regulatory decision making process,” he said. Regulatory guidance encourages stakeholders to use information contained in electronic health records, insurance claims databases and registries to help support more efficient regulatory decisions for medical devices.