Blog Tag: Robert Califf
FDA Establishes Patient Engagement Advisory Committee
The FDA recently announced establishment of the Patient Engagement Advisory Committee (PEAC). According to a notice published by the FDA, the PEAC will advise the Commissioner of the FDA, presently Dr. Stephen Ostroff, M.D., “on complex issues relating to medical devices, regulation of devices, and their use by patients.” In an FDA Voice blog post, Nina L. Hunter, Ph.D., and Robert M. Califf, M.D., stated:
[The PEAC] will give FDA the opportunity to obtain expertise on various patient-related topics, with the goal of improving communication of benefits and risks and increasing integration of patient perspectives into the regulatory process.
According to the FDA, PEAC will have 9 core voting members, including a committee chair, to be selected by the Commissioner. The voting members, who will have expertise in patient needs in connection with medical care, clinical research, and healthcare communication, will serve overlapping terms of up to 4 years. The notice states that the Commissioner may also select a technically qualified voting consumer representative recommended by consumer oriented organizations. Depending on the meeting topic, a pool of nonvoting industry representatives selected by the Commissioner and nominated by the medical device industry may also participate in PEAC meetings.
The FDA has established a public docket for comments on topics the PEAC could consider, which currently include: “[FDA] 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 and device-related quality of life or health status issues, and other patient-related topics.” The public is invited to provide comments online, or by mail to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments must reference Docket No. FDA-2015-N-3166, and must be received by the FDA by November 20, 2015.
The FDA is also soliciting nominations for voting members, which must be received by November 20, 2015, the voting consumer representative, which must be received by October 21, 2015, and a pool of nonvoting industry representatives, which must be received by October 21, 2015.