New FDA Patient Engagement Advisory Committee

FDALogo2The U.S. Food and Drug Administration recently announced (80 Fed. Reg. 57007, 9/21/15) the creation of the Patient Engagement Advisory Committee (PEAC) to advise the agency “on complex issues relating to medical devices, regulation of devices, and their use by patients,” and will receive public comment on potential PEAC topics until 11/20/15.  The PEAC will be composed of nine voting members, including the chair, as well as temporary non-voting members selected for particular PEAC meeting topics.  The FDA Commissioner or designee will select the voting PEAC members envisioned to be experts in “clinical research, primary care patient experience, and health care needs of patient groups in the United States,” or “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.”  The FDA is receiving nominations for PEAC nonvoting members from industry organizations until 10/21/15 (80 Fed. Reg. 57004), nominations for PEAC voting members from consumer organizations until 10/221/15 (80 Fed. Reg. 57002), and nominations for PEAC members from the general public until 11/20/15 (80 Fed. Reg. 57003).  For additional information, see the FDA Patient Engagement Advisory Committee page.