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Drugs & Medical Devices

FDA Patient Advisory Committee on Medical Devices

— September 21, 2015

There is a new FDA committee on its way. The agency announced last week that it is forming the first-ever FDA Patient Advisory Committee on Medical Devices. The FDA hopes to get real patient input in the development, approval and monitoring processes it uses for medical devices.


In what appeared to be a revolutionary step, the U.S. Food and Drug Administration announced on Friday that it has created its first FDA patient advisory committee on medical devices.

The eleven-member committee has nine voting members who are “knowledgeable in areas such as clinical research, primary care patient experience and health care needs of patient groups in the United States.” There is also one non-voting “industry representative” and one non-voting “consumer representative.”

The purpose of the advisory committee is to bring a patient perspective into FDA decisions regarding medical device development, approval and monitoring. The FDA wants the committee to assist it in its efforts to “meet its public health commitment to improve patient health and quality of life.”

The committee’s duties include offering suggestions about PDA rules, policies and designs regarding clinical trials and device labeling. The committee will also oversee finding new ways to find patient preferences, how to meet unmet clinical needs and improvements in reporting patient experiences with medical devices. The FDA has opened a 60-day public comment period to help it prioritize the committee’s areas of responsibility.

FDA room

One area of responsibility includes determining just how and when patients should have input into the life cycle of medical devices. Other areas include developing means of patient recruiting and retention for research projects.

Comments have been rolling in from health researchers and consumer advocates and so far, the reaction to the committee’s formation is cautious.

Dr. Michael Carome, director of health research at Pubic Citizen, a consumer group, said, “Often so-called patient groups are sponsored heavily by the medical device industry. 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.”

UPDATE: I am pleased to correct an error in quoting Diana Zuckerman, president of the National Center for Health Research, a think tank dealing with medical device safety and effectiveness. I appreciate her time in letting me know of the error.

Her original point is this: “I agree with Dr. Carome that too many ‘patient representatives’ have very close ties to industry and are not independent voices.  …[W]hat we need are independent patient voices (not industry-affiliated ones) [whose] perspectives can help us better understand scientific data on safety and effectiveness, but should not replace scientific evidence.”

These unheard parties are traditionally treated as “an annoyance by most FDA committees, she added. Yet Zuckerman is uncertain that “segregating them into their own panel will be helpful.”

Industry sponsoring of patient representatives creates reps who are often biased toward their sponsors. In addition, she 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.”

Perhaps the FDA has made a step in the right direction. If it holds true to its intent, the advisory committee could help revolutionize the processes of medical device development, approval and monitoring. However, if Zuckerman is correct, it may end up being just another great idea gone wrong.


FDA to establish patient advisory committee on medical devices

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