FDA forms patient engagement advisory committee for more input

The FDA has created the Patient Engagement Advisory Committee (PEAC) which will provide advice to the FDA commissioner on a range of complex issues relating to medical devices, the regulation of devices and their use by patients.

The committee 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 an article on the agency's website authored by Nina L. Hunter, PhD, a regulatory scientist in FDA's Center for Devices and Radiological Health, currently on detail as a special assistant for medical policy to the Office of Medical Products and Tobacco, and Robert F. Califf, MD, FDA's deputy commissioner for medical products and tobacco.

FDA hopes to get patients' perspectives on the most important benefits and risks of a technology and the relative importance of benefits and risks and the tradeoffs for a given technology and gain a better understanding of how patient preferences vary across a population. 

Hunter and Carliff wrote that even "rigorous, systematically gathered patient preference information" would "not be used to justify approval of unsafe or ineffective devices. FDA's sharpened focus on patient-centered technology development, evaluation and use has already begun to positively affect the development of innovative therapies and clinical solutions" and are "helping to drive a more patient-centered medical product development and assessment process."

The committee will discuss FDA policies and guidance, clinical trial and study design, device labeling, clinics' unmet needs and risk-benefit analysis for medical devices.

The PEAC will consist of nine voting members appointed by the FDA commissioner with backgrounds in clinical research and primary care, as well as one non-voting member who will represent the medical device industry. Members will participate in public meetings twice a year and serve on the panel for four years. Applications to serve on the panel must be submitted by Oct. 21.