FDA forms first patient engagement committee


The FDA will form its first-ever patient engagement advisory committee, which will advise the agency's commissioner on issues related to the regulation of medical devices as well as how patients use them.

The nine-person committee will counsel the FDA on topics such as guidance, policies, clinical trials, registry design, patient-preference study design, benefit-risk determinations, device labeling, unmet clinical needs and patient reported outcomes.

“It's a huge step in the right direction to have the FDA form a patient advisory committee, and it should encourage industry to step up those good efforts,” said Jack Barrette, CEO of patient advisory organization Wego Health. “FDA's done well to think beyond ‘patient-centric' approaches that look at patients from the outside instead of creating real collaboration.”

The FDA said it hopes the committee will help improve its communication of benefits, risks and outcomes by integrating the patient perspective into the regulatory process. The committee will accomplish this by identifying new approaches, promoting unforeseen risks and identifying unintended consequences that could result from an FDA policy.

In an FDA blog post on the announcement, Dr. Robert Califf, deputy commissioner for medical products and tobacco, and Nina Hunter, a regulatory scientist at the FDA's Center for Devices and Radiological Health, wrote: “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.”

The Obama administration this week said it would nominate Califf as FDA commissioner.

Dr. Stephen Ostroff, currently the FDA's acting commissioner, will select the nine voting members, including a chairperson. The FDA is looking for experts with experience in clinical research, primary-care patient experience and healthcare needs of patient groups.