FDA Creates Patient Engagement Advisory Committee

A new patient advisory committee is being formed to provide feedback and advice to federal regulators concerning issues facing patients and families involving medical care. 

The formation of a new FDA Patient Engagement Advisory Committee (PEAC) was announced earlier this month in the FDA Voice, an agency-produced blog.

The new PEAC committee will offer advice to the FDA and it’s commissioner on a range of patient related topics in medicine.

In creating patient focused technology and medical regulations, the FDA indicates that it attempts to “improve patient lives,” yet has to this point relied upon expert opinions, instead of pointedly asking patients and families directly what they consider important in medical care.

Agency officials say the new advisory committee takes a step toward the FDA’s goal of “patient-centered” medicine, inviting patients and care partners to participate actively in decision-making and setting priorities in all aspects of health care.

“Americans are becoming increasingly active consumers of health care, making choices about their doctors, diagnostics, treatments, and healthcare experiences rather than simply allowing health care providers to make the decisions for them,” said FDA regulators Nina L. Hunter, Ph.D. and Robert F. Califf, M.D., in the blog.

The PEAC will consist of nine voting members, including the chair, who are selected by the commissioner or a designee from experts knowledgeable in areas, like clinical research, primary care patient experience and health care needs of patient groups in the U.S.

Committee members are eligible to serve for overlapping terms of up to four years and may also be recommended by a consortium of consumer oriented organizations.

The PEAC will bring their own experience to help define “meaningful benefits or unreasonable risks.” They will weigh in on a range of topics, including medical devices, regulation of devices and use by patients, agency guidance and policies, clinical trials, patient preference study design, device labeling, unmet clinical needs, and available alternatives, among other topics.

This will give the FDA the opportunity to obtain expertise on patient-related topics with the goal of improving communication of benefits and risks and integrating patient perspectives into the regulatory process.

The FDA emphasized that patient preference received through PEAC will not be used to justify approval of unsafe or ineffective devices or practices. However, the agency points out that the information is most useful in helping determine important benefits and risks of technology from patient perspective, assessing importance of different attributes of benefits and risk, and understanding how patient preferences vary across population.

Overall, Hunter and Califf say the agency hopes to “better integrate patient views” into its decision-making.

”While it’s important to consider patient perspectives, we understand that patients still expect FDA to do our primary job — namely, ensuring the safety and effectiveness of FDA-regulated medical devices,” Hunter and Califf wrote.