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.” […]
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.”
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