There has been a surge in the development of new medical technologies over the last couple of decades. When looking at the way these developments have come about, it may seem odd when one realizes that these were largely developed based on expert opinions, not by asking patients and families directly what they consider most important.
That way of thinking is slowly starting to change and become more “patient-centered.” Patients, their physicians, and other care partners are beginning to actively participate in the decision-making and priority-setting about all aspects of their health care, and this is starting to have an impact on the medical industry.
According to Nina L. Hunter, Ph.D., and Robert M. Califf, M.D., Americans are becoming more active consumers of health care by making decisions about their doctors, diagnostics, treatments, and health care experiences instead of allowing their health care providers to make those decisions for them.
In an effort to adjust to this new “patient-centered” thinking, the Food and Drug Administration has recently announced their establishment of the Patient Engagement Advisory Committee (PEAC). The PEAC will be responsible for advising the commissioner of the FDA “on complex issues relating to medical devices, regulation of devices, and their use by patients.” The PEAC will aim to “improve communication of benefits, risks, clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices.”
The PEAC will have nine voting members who are selected by the Commissioner and should be knowledgeable in different areas, such as clinical research, primary care patient experience, and health care needs of patient groups throughout the United States. Members of the PEAC will be invited to serve terms up to four years and almost all non-Federal members of the committee will serve as Special Government Employees.
The FDA is soliciting feedback on topics for the PEAC to discuss and advise the Agency. Some topics the FDA is planning for the PEAC to cover are: where can patients provide input across the medical device total product lifestyle?; how should FDA directly engage patients for input related to medical device premarket considerations?; how should FDA engage patients for input related to medical device performance once products are available on the market?; and how should sponsors present patient preference information or PROs in the health care professional and patient labeling?
The FDA has opened a docket for public comment on the potential topics, which will remain open through November 20, 2015. Additionally, the FDA is soliciting nominations for voting members, which must be received by November 20, 2015 and nominations for the voting consumer representative and a pool of nonvoting industry representatives, both of which must be received by October 21, 2015.
The FDA is looking forward to working with others to help advance the science of patient input and believe that their focus on patient-centered technology development, evaluation, and use has already started to positively affect the development of innovative therapies and clinical solutions.