FDA’s new patient-centric advisory committee to provide additional input on device regulation

The committee of outside experts will conduct open public meetings about twice a year.  It will consist of 9 voting members, as well as one nonvoting industry representative and one nonvoting consumer representative. Experts from other FDA and NIH advisory committees can also serve on the committee if their knowledge is necessary for a particular topic.  The committee will not necessarily opine on specific products or diseases but will instead be asked to weigh in on a variety of important patient-related issues, the FDA says.

Its initiative builds on some of its previously announced goals and achievements.  In a May 2015 draft guidance, the Agency said patient-preference information could someday result in approval among a subset of the relevant population, such as those under a certain age, who may have a higher risk tolerance than their older counterparts.  And CDRH head Dr. Jeffrey Shuren often boasts about the Agency’s approval of the obesity-fighting Maestro Rechargeable System on the basis of a survey of patients, which showed that they would accept the risks of the device for the amount of weight loss expected to be provided by the technology.  He has promised to incorporate such information into more approval decisions.

The committee’s other areas of focus include patient-reported outcomes and device labeling.  Both would benefit from taking a more patient-centric approach.  The panel could think of ways to encourage patients to submit adverse event reports, and help the agency handle other methods of reporting outcomes, such as complaints (or compliments) made public over social media.

Meanwhile, the FDA’s intense focus on labeling sometimes feels like it’s intended to meet the needs of lawyers, while forgetting that the language (often in the form of tiny print squished onto a folded paper) must actually be first read and then understood by patients in order for it to be meaningful.  After all, inadequate patient communication has contributed to safety scares like that posed by power morcellation, which can spread undetected cancers outside of the uterus.  And it follows that better communication is a big part of the solution of as well.

Still, patient advocates are suspicious of the new panel, according to the Minneapolis StarTribune. “Often so-called patient groups are sponsored heavily by the medical device industry,” Dr. Michael Carome, health research director at the consumers’ watchdog Public Citizen, told the paper.  “Patients can make the agency aware of unmet medical needs.  However, when (the FDA) decides whether or not to approve a device, the decision should be made based on scientific research and not patient preference.”  Meanwhile the president of the National Center for Health Research, Diana Zuckerman, said she is not sure if “segregating them (patient representatives) into their own panel will be helpful.”

The FDA’s device arm also receives feedback from the Good Manufacturing Practice Advisory Committee, and the Medical Devices Advisory Committee, which provides feedback on and recommends approval (or rejection) of, companies’ PMA submissions for the commercialization of high-risk devices.

REFERENCE:  Fierce Medical Devices; 21 SEP 2015; Varun Saxena

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