FDA Rule Establishes Patient Engagement Advisory Committee

FDA Finalizes the Establishment of the Patient Engagement Advisory Committee

In October 2015 the FDA established its first ever Patient Engagement Advisory Committee (PEAC). This was done as part of the Agency’s ‘patient-centric’ approach, under which FDA is attempting to ensure the needs and experiences of patients are taken into account during the review of medical devices.

The Committee

The committee consists of nine voting members, including one committee chair, all selected by the FDA Commissioner. Committee members are invited to serve overlapping terms of up to four years. The members are comprised of “authorities who are knowledgeable in areas such as clinical research, primary care patient experience, and healthcare needs of patient groups in the United States, or who are 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.” In addition, FDA states that “the core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons.”

The committee has been established for in order to provide the FDA Commissioner with advice regarding complex issues related to medical devices; specifically regarding the regulation of devices, and their use by patients. Topics that may be considered by the committee include:

  • FDA guidance & 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.

FDA states that the committee “will perform its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy.”

Final Rule

On Monday, March 21st, the FDA published a notice in the Federal Register announcing that the committee has been formally added to the roster of Advisory Committees. The final rule, which is effective immediately, amends Title 21 of the Code of Federal Regulations Part 14 (21 CFR 14.100), which provides a list of all standing advisory committees.

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