Last week, the Food and Drug Administration (FDA) announced the creation of a Patient Engagement Advisory Committee (PEAC) to advise the FDA Commissioner on complex issues relating to medical devices, the regulation of devices and their use by patients.
In a blog post announcing the PEAC, Nina Hunter, Ph.D., a regulatory scientist in the FDA’s Center for Devices and Radiological Health, said 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.”
“Some questions that the PEAC may discuss include where and how best to engage patients across the device development and assessment lifecycle as well as how FDA and sponsors should communicate patient preference information to patients. The PEAC represents a new and exciting opportunity to foster patient partnerships with FDA, and it complements other efforts at FDA to bring the patient into the medical device regulatory process,” Hunter stated. Hunter also serves as a special assistant to Robert Califf, M.D., the FDA’s Deputy Commissioner for Medical Products and Tobacco.
According to the FDA announcement, the PEAC may consider topics such as agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, patient reported outcomes and device-related quality of life or health status issues, and other patient-related topics.
The PEAC will provide relevant skills and perspectives, in order to improve communication of benefits, risks, clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices, the FDA statement said. And, the PEAC will also provide advice and recommendations in areas such as identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers and identifying unintended consequences that could result from FDA policy.
“We are entering an era of ‘patient-centered’ medicine in which patients and their care partners participate actively in decision-making and priority-setting about all aspects of health care,” Hunter wrote. “FDA believes that patients can and should bring their own experiences to bear in helping the Agency define meaningful benefits or unreasonable risks for certain new devices.”