On Friday, the FDA announced its first-ever Patient Engagement Advisory Committee (PEAC) that will provide advisory support to the FDA Commissioner on a range of complex issues relating to medical devices, the regulation of devices, and their use by patients. These ultimate goal of the PEAC is to helping to drive more patient-centered medical product development and assessment process.
Other topics the committee may consider include:
– Agency guidance and policies
– clinical trial or registry design
– patient preference study design
– benefit-risk determinations
– device labeling
– unmet clinical needs
– available alternatives
– patient reported outcomes
– device-related quality of life or health status issues
“We are entering an era of “patient-centered” medicine in which patients and their care partners participate actively in decision-making and priority-setting about all aspects of health care. Americans are becoming increasingly active consumers of health care, making choices about their doctors, diagnostics, treatments, and healthcare experiences rather than simply allowing health care providers to make the decisions for them. Moreover, FDA believes that patients can and should bring their own experiences to bear in helping the Agency define meaningful benefits or unreasonable risks for certain new devices,” said Nina L. Hunter, Ph.D., a Regulatory Scientist in FDA’s Center for Devices and Radiological Health in the announcement.
The Committee will consist of a core of nine voting members, including the Chair. Members and the Chair are selected by the Commissioner or designee from subject matter experts in areas such as clinical research, primary care patient experience, and health care needs of patient groups in the United States. Selected Committee members may also be experienced in the work of patient and health professional organizations; methodologies for eliciting patient preferences; and strategies for communicating benefits, risks and clinical outcomes to patients and research subjects.
PEAC Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The voting members may include one consumer representative who is a technically qualified member, selected by the Commissioner or designee, identified with consumer interests, and is recommended by either a consortium of consumer oriented organizations or other interested persons.
The Commissioner or designee will have the authority to select from a group of individuals nominated by industry to serve temporarily as non-voting members who are identified with industry interests. The number of temporary non-voting members selected for a particular meeting will depend on the meeting topic.