FDA announces new patient engagement committee
In a recent blog entry, the FDA unveiled its new Patient Engagement Advisory Committee (PEAC), a group which will give the FDA commissioner input on issues related to medical devices and device regulations.
Nina L. Hunter, PhD, a regulatory scientist in FDA’s center for devices and radiological health, and Robert M. Califf, MD, FDA’s deputy commissioner for medical products and tobacco, co-authored the announcement, saying the PEAC is one of many ways the federal agency is striving to build relationships with patients in the U.S.
“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,” Hunter and Califf wrote. “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.”
The PEAC will consist of nine voting members, who are chosen for their understanding of topics such as clinical research and patient needs. Meetings will also often include numerous non-voting members.
For more information on this new committee, visit the FDA’s website and official blog.