Committee to advise FDA on device regulation
The FDA, seeking to involve actual users of medical devices who could influence decision-making, has created its first-ever patient engagement advisory committee (PEAC) on medical devices.
The 11-member group, formed by the FDA’s Center for Devices and Radiological Health (CDRH), will provide additional perspectives on such topics as patient preference information, risk-based determination and device labeling. The committee, comprised of outside experts, will include nine voting members with “knowledge in areas such as clinical research, primary care patient experience and healthcare needs of patient groups in the United States,” the agency stated. The group also will have two non-voting members: a consumer representative and an industry representative.
In addition, the FDA stated that the nine experts can include other FDA and NIH advisory committee members who also may serve on the committee if their knowledge is necessary for a practical topic.
The committee, the FDA noted, is designed to inject a patient perspective into the agency’s deliberations on device development, approval and monitoring. It also will help the government “meet its public health commitment to improve patient health and quality of life.”
While the committee will not express opinions on specific products, it will be asked to weigh in on important patient-related issues and offer suggestions, the agency stated. One of the advisory committee’s primary missions is to help figure out how and when patients should have input into the medical device life cycle.
“Some questions that the PEAC may discuss include where and how best to engage patients across the device development and assessment lifecycle, as well as how the FDA and sponsors should communicate patient preference information to patients,” wrote Nina L. Hunter, Ph.D., a regulatory scientist at the CDRH in an FDA blog posting co-authored with Robert Califf., M.D., the FDA’s deputy commissioner for medical products and tobacco, who recently was nominated to become FDA commissioner.
In a May draft guidance, other potential areas could include new ideas for recruiting patients and retaining them, along with improving ways for members of the public to report their experiences with medical devices once they are implanted and informing the public about the risks of products that are now on the market.
Still, some patient advocate groups expressed concern about the new PEAC and its influencing role in clinical trials.
“We don’t oppose the idea of more patient engagement as a general principle to identify unmet medical needs, as there are good examples of patient driven advocacy, which is important,” said Michael Carome, M.D., director of the health research group
at the consumer watchdog Public Citizen. “Our concern is when the FDA decides whether or not to approve a device, as that decision should be made on the basis of scientific research—not the preferences of patients.”
He cited an example, from earlier this year, of a medical device called the Maestro Rechargeable System that was FDA-approved for weight loss despite a failure to meet its primary endpoint of a clinical trial. Maestro also received a mixed reception from the advisory committee, with a majority of members voting that it failed to demonstrate the expected weight-loss effectiveness.
The FDA’s action, however, was based largely on a CDRH Patient Preference Weight Loss Devices Study that, according to the FDA, “showed a group of patients would accept risks associated with [the Maestro] surgically implanted device for the amount of weight loss expected to be provided in the device.”
To Carome, the FDA patient preference information was a substitute for evidence of efficacy where the device had failed to achieve a clinically meaningful benefit. “That was a troubling outcome and I wonder about how the FDA, with this new committee, will handle evidence that does not meet standard effectiveness,” said Carome.
Another patient advocate group, the National Center for Health Research, also expressed concerns over whether separating patients is sufficient. Diana Zuckerman, the organization’s president, told The Minneapolis Star Tribune that she is not sure if “segregating them (patient representatives) into their own panel (PEAC) will be helpful.”
Ronald Rosenberg is a former business and science reporter for The Boston Globe. He has written features for New Scientist and Inc. magazine. His lengthy journalism career includes editing an award-winning weekly newspaper in Cornwall, N.Y. Ron also was a media relations specialist for the science faculty at Boston University, and a Knight Science Journalism Fellow at the Massachusetts Institute of Technology.
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