By Kelly A. Briganti, Editorial Director, G2 Intelligence
Recognizing the shift to “patient-centered medicine,” the U.S. Food and Drug Administration (FDA) announced last week the first-ever Patient Engagement Advisory Committee (PEAC), advising the FDA Commissioner on issues regarding medical devices, their regulation and use. A Sept. 18 FDA Voice blog announcing the new committee acknowledged the increasing involvement of patients in health care “decision-making and priority-setting.” PEAC will address how best to involve patients in device development and assessment and how to improve communication between FDA, sponsors and patients.
Voice blog authors, Nina L. Hunter, Ph.D., a regulatory scientist in the FDA’s Center for Devices and Radiological Health and Robert M. Califf, M.D., deputy commissioner for Medical Products and Tobacco, wrote: “Americans are becoming increasingly active consumers of health care, making choices about their doctors, diagnostics, treatments, and health care experiences rather than simply allowing health care providers to make the decisions for them.” The authors cautioned that while patients can help the agency “define meaningful benefits or unreasonable risks” of new devices, patient preference information won’t be used “to justify approval of unsafe or ineffective devices.”
Hunter and Califf touted the new committee as “a new and exciting opportunity to foster patient partnerships with FDA,” adding that it “complements other efforts at FDA to bring the patient into the medical Device regulatory process” such as studies of patient preferences regarding medical devices, and draft guidance on patient preference information for PMAs, HDE applications and de novo requests.
Federal register notices published September 21 describe the committee as consisting of nine voting members serving up to four year terms. Members will be chosen for their knowledge of clinical research, patient care, the needs of patient groups and ways of soliciting patient preferences. The FDA Is soliciting comments through Nov. 20, 2015 regarding potential topics for the Committee to address.