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Henry Miller: FDA has device makers looking outside U.S.
Regulatory disincentives have consequences, and device companies are voting with their feet.
Medical devices are something of an orphan sister to the glamour of drugs, but they include some of the genuine miracles of modern medicine: pacemakers, artificial joints, cardiac stents, scanners and radiotherapy machines. The United States currently is the global leader in medical device innovation, and it is one of the few major industries that both boasts a net trade surplus and is a job-creator. The sector employs 400,000 Americans directly and is indirectly responsible for almost 2 million more that supply and support the highly skilled workforce.
But the medical device industry is being ravaged by unwise and excessive public policy. Regulatory disincentives have consequences, and device companies are voting with their feet. They have begun to move R&D and manufacturing offshore and even to write off the U.S. market for certain products that are so over-regulated that financing for their testing is unobtainable.
An example of the Food and Drug Administration’s misuse of its discretion concerns the Fisher Wallace Stimulator, a portable device used to treat depression, anxiety and insomnia – common symptoms of Post-Traumatic Stress Disorder. It causes no serious side effects and has been on the market without incident since 1991. Because it gained clearance through antiquated “grandfathering” laws, the FDA must now either reclassify the device from Class 3 (usually support or sustain human life, or may pose a high risk of illness or injury) to Class 2 (low-medium risk) or relegate it to an approval process that requires clinical trials on par with hugely expensive drug trials – impossible for a device company that generates under $10 million annually in revenue.
The company’s reclassification hearing took place in February. Although the FDA’s panel of outside experts agreed that device is safe, they were strongly divided over whether to reclassify the device based on effectiveness data that lacked the robustness of full-blown drug trials.
Such disagreements are not unusual, but what is noteworthy is that FDA seems actually to have engineered the impasse by manipulating the composition of the panel for this particular meeting. One of the most prominent members of the panel, Dr. Alvaro Pascual-Leone, professor of Neurology and Director of the Berenson-Allen Center for Noninvasive Brain Stimulation at Harvard Medical School, was absent. FDA said at the hearing that Dr. Pascual-Leone was “unable to attend” but thereafter, he informed Fisher Wallace via email that the agency had instructed him not to show up.
Given Dr. Pascual-Leone’s well-known support of brain stimulation technology, his removal from the panel seems to have been intended to influence its recommendations. If that is so, it indicates the extent to which the FDA will go to manipulate the supposedly disinterested expert advice it receives. (What makes the regulators’ actions to bias the panel discussion particularly problematic is that advisory groups’ recommendations are only advisory, and need not be accepted by FDA.)
New York City-based Fisher Wallace Laboratories currently manufactures its products in New Jersey and sells them to American veterans of the Vietnam, Iraq and Afghanistan wars. If the FDA decides not to reclassify the company’s device, Fisher Wallace has said it will likely shift its focus abroad, which would leave American veterans and active-duty military personnel without this safe treatment at a time when PTSD is at record levels, and the suicide rate among active-duty troops has overtaken the number dying in battle in Iraq and Afghanistan.
An interesting aspect of medical devices is that many of them originate not from industry behemoths but from individual tinkerers. Perhaps the epitome of the phenomenon is the Fogarty catheter, which has been used for almost half a century to remove blood clots from blood vessels relatively noninvasively. It was invented during the late 1950s by medical student Thomas Fogarty, who went on to become a renowned cardiac surgeon, inventor and entrepreneur. (He is still at it, and has become a noted California winemaker as well.)
More than 23 million of the Fogarty catheters have been manufactured. But consistent with the observation of a former head of the FDA that “dogs bark, cows moo, and regulators regulate,” regulators seem to be trying to squelch this kind of garage-inventor innovation.
Consider the sorry saga of Connecticut psychologist and educator Robert Reynolds, who invented a low-tech gizmo for teachers to use in the classroom for children with attention and behavior problems – a simple radio-frequency device that allows a teacher to send two different pager-like vibrations to a student’s watch. One kind of vibration reminds him when he is off-task, and a slightly different one is sent if he self-corrects and is on-task. The watch tracks the points the student earns, for which he can receive prearranged awards.
Sounds like an update of the way the gold stars in my copy-book and a few words from the teacher were used when I was a kid, but FDA apparently saw this as an opportunity to flex their bureaucratic muscles – and they threw the book at this guy, burying him in a hugely expensive, terrifying, Kafkaesque experience.
According to Reynolds, when FDA found out about his invention, they investigated him and concluded that the off-task vibration could “become a noxious stimulus for some child and he or she might develop some psychiatric syndrome as a result.” Therefore, they charged him with using and selling an “adulterated and misbranded medical device,” a federal crime. This is a classic example of bureaucrat-think because, as Reynolds observed, “Common sense would tell you that these children are already dealing with noxious events – their teacher constantly yelling at them.”
These examples epitomize an agency that seems lately to use its power in ways that contravene decency and compassion toward patients. American taxpayers, ill or healthy, deserve better.
Miller, a physician and fellow at Stanford University’s Hoover Institution, was founding director of the FDA’s Office of Biotechnology.
- FDA – Overview of Medical Device Regulation > Information about MDUFA III (earlsview.com)
- Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions (earlsview.com)
- FDA to help medical device sales with expanded pre-market feedback program (earlsview.com)
- FDA to guide device makers on marketing application – chicagotribune.com (earlsview.com)
- Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today (earlsview.com)
- FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments (earlsview.com)
- Medical Device ID Proposal Unveiled – GovInfoSecurity (earlsview.com)
- FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier (earlsview.com)
- Medical Device ” The Senate Passes Unparalleled Medical Device User Fee Act (earlsview.com)
- FDA – User Fees for Medical Devices: Third Time Lucky? (earlsview.com)