FDA launches patient engagement committee

Aims for a 'more patient-centered medical product development and assessment process'
By Mike Miliard
06:21 AM
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As healthcare enters an era in which "patients and their care partners participate actively in decision-making and priority-setting," FDA has launched its first-ever Patient Engagement Advisory Committee).

Officials say the group will offer perspective to the FDA Commissioner on issues related to regulation of technology and medical devices, and their use by patients. FDA will learn about patient-related topics and better integrate those patient perspectives into its regulatory process.

"Although it may seem odd in retrospect, the development of new technologies intended to improve patients' lives has largely relied upon expert opinions rather than asking patients and families directly what they consider most important," write Nina L. Hunter, a regulatory scientist in FDA's center for devices and radiological health, and Robert F. Califf, MD, FDA's deputy commissioner for medical products and tobacco, in a blog post announcing the launch.

[Related: Meet the speakers at the HIMSS and Healthcare IT News Patient Engagement Summit.] 

PEAC aims to change that, as it examines issues related to, for example, "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," according to the post.

"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."

Such patient input could be key to helping identify the most important benefits and risks of a technology from a patient's perspective; assessing the relative importance to patients of different attributes of benefit and risk and under how patient preferences vary across a population, Hunter and Califf write.

"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," they add. "These efforts are helping to drive a more patient-centered medical product development and assessment process."

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