NCHR’s Statement to FDA Advisory Committee Meeting on Neurological Devices

June 3, 2021

I’m Dr. Diana Zuckerman, president of the National Center for Health Research.  Our center is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products.  Today I’m speaking from my perspective as a scientist trained in epidemiology and public health who left Harvard more than 30 years ago to come to Washington D.C. to work in the House of Representatives. I worked as a Congressional investigator for the Subcommittee that conducted oversight over all of HHS, and that’s when I first learned about the laws and regulations governing the FDA.  I was responsible for several oversight hearings that attracted enormous media attention, because we found that patients had been harmed when the FDA was not following the law pertaining to FDA regulation of medical devices.

The law states that devices must be reasonably safe and effective.  It’s not exactly clear what reasonably safe or reasonably effective means, and often the FDA states that if they have reason to believe that similar devices are reasonably safe and reasonably effective, that’s good enough.  The special controls for Class II devices that the FDA has suggested for devices you’re reviewing today and tomorrow provide some evidence that the devices will work as intended and will be reasonably safe, but the general controls for Class I devices do not.

Neurological devices are important, and some of these devices are somewhat complex.  Obviously something called a “barf band” is not a complicated device, and it is an example of an acupressure device that costs only about $10, but if the goal is to prevent nausea and vomiting, and the company wants to sell it in the U.S., shouldn’t it be proven to work, like any other neurological device?  And some of those devices cost $20 or $30 or even over $200.   Just because the risks are small should not make it OK for FDA to let companies sell devices that are not effective if used as directed.  The standards for medical devices should be higher than the “let the buyer beware” standards of dietary supplements – which are basically nonexistent standards.

I was reassured that there are randomized controlled trials on many of the devices you’ll be reviewing today and tomorrow, but there are many different companies making many different versions of these devices, so the fact that some are shown to work doesn’t mean that they all work!  For example, when  chemotherapy patients want to reduce nausea and vomiting, they want to know if one of these acupressure devices is more effective than others.  And even when some devices are shown to work in a randomized controlled trial, that definitely doesn’t tell us that a new, similar device made by these same companies or any other companies will be safe and will be effective.  

The FDA has a reputation as the gold standard for safe and effective medical products, but that standard has been tarnished when patients are shown to be harmed in recent documentaries and in TV programs on during prime time this week.

I respectfully urge you to urge the FDA to up their game, by regulating all these neurological devices as Class II, and requiring the kind of meaningful evidence for new devices that we would want for any device that we use as health professionals, as patients, or as consumers.

Thank you for the opportunity to speak today.  I appreciate your service on this panel and look forward to hearing your discussion of these devices.