FDA to establish patient advisory committee on medical devices

WASHINGTON – The U.S. Food and Drug Administration on Friday announced the establishment of its first-ever patient advisory committee on medical devices.

The new 11-member group will include nine voting members "knowledgeable in areas such as clinical research, primary care patient experience and health care needs of patient groups in the United States." The committee will also have one nonvoting "consumer representative," and one nonvoting "industry representative."

The committee, according to the FDA, is designed to inject a patient perspective into the agency's deliberations on device development, approval and monitoring. The FDA says the committee will help the government "meet its public health commitment to improve patient health and quality of life."

Among other things, the committee will offer suggestions about FDA policies and rules and designs for clinical trials and device labels. It also will examine ways to determine patient preferences, how to best report patient experiences with medical devices and how to remedy unmet clinical needs.

The agency has asked for 60 days of public comments to prioritize those points of concern.

One of the primary missions of the committee will be to help figure out when and how patients should have input into the medical device life cycle.

Potential areas of focus could be methods of recruiting patients to and keeping them in research projects. But other potentially significant pieces will be improving ways the public can report their experiences with devices once they are implanted and with telling the public about risks of products that are already on the market.

Consumer advocates and health researchers offered a guarded response to the FDA announcement.

"Often so-called patient groups are sponsored heavily by the medical device industry," said Dr. Michael Carome, health research director at the consumer group Public Citizen. "Patients can make the agency aware of unmet medical needs. But when [FDA] decides whether or not to approve a device, the decision should be made based on scientific research and not patient preference."

There is a "big problem" with the lack of influence of patients and consumers in the device approval and monitoring processes, added Diana Zuckerman, president of the National Center for Health Research, a think tank focused on the safety and effectiveness of medical devices.

Patients and consumers have traditionally been treated as "an annoyance" by FDA committees, Zuckerman said. Still, she is not sold on the idea that "segregating them into their own panel will be helpful."

Besides industry sponsorship of supposed patient representatives, Zuckerman said, "We seem to get the same three patient representatives on every panel. We are not getting true independent voices of people who have experience with drugs or devices."

Jim Spencer • 202-383-6123