Opinions are all over the map when it comes to whether the FDA regulates medical devices too strictly or too loosely. Those favoring more regulation point to infamous examples like metal on metal hips and faulty defibrillator leads. Power morcellators and duodenoscopes are the latest additions to that list. Industry and others who favor faster access note that in Europe, many advanced devices are made available years before they are commercialized in the U.S.
The conflicting opinions and evidence reflect the complexity of the task facing the FDA and its device arm, CDRH. The Wall Street Journal convened three experts for a roundtable discussion about device regulation.
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| Dr. Rita Redberg, UCSF |
Cardiology professor Dr. Rita Redberg of the University of California, San Francisco, favors stricter FDA regulation.
"As a cardiologist taking care of patients every week, I see too many whose lives have been harmed and who have suffered greatly from untested or inappropriate devices," she said, referring to the Premarket Approval (PMA) pathway. "And that doesn't begin to address the billions of dollars these devices add to health-care bills. Only a few percent of all devices on the U.S. market go though the only pathway that requires any clinical data. And even that most-stringent pathway doesn't require two randomized clinical trials."
Meanwhile, former FDA deputy commissioner and resident fellow at the American Enterprise Institute, Scott Gottlieb, disagrees. He said that the agency shouldn't regulate medical devices like drugs, and noted that subjecting patients to "sham" surgeries involving placebo devices subjects them to unnecessary risks but none of the benefits.
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| Scott Gottlieb |
Note that the medical device approval pathway is less arduous than that for drugs. Manufacturers of combination products frequently fight with the FDA when the agency decides to regulate the candidate product through one of the drug approval pathways.
Bradley Merrill Thompson, device attorney with Washington's Epstein, Becker & Green, said the use of sham surgeries is not an example of FDA overregulation because they were conducted at the request of the company being regulated. As such, sham surgeries are not often conducted in medical device clinical trials.
The often-cited failure of a Medtronic's ($MDT) Fidelis defibrillator lead, which lead to multiple patient deaths, occurred 8 years ago, Thompson noted, saying "the fact you need to go back that far speaks to the overall robustness of the FDA process."
And in spite of harm caused by some devices like power morcellators, which can spread hidden preexisting cancer throughout the body, patients can be harmed by excessive regulation as well.
"Out of all of the thousands of medical devices that the FDA clears each year, how many turn out to be unsafe or ineffective? Not many. But further, and equally importantly, how effective are alternative regulatory systems in approving important new medical devices in a timely way? Changing the system in a way that delays or even forecloses the sale of safe and effective breakthrough medical devices hurts patients, too," Thompson said.
Observers agree that the agency has improved relations with the medical device industry under the tenure of outgoing FDA commissioner Margaret Hamburg. The FDA's device arm has clarified its processes and taken industry-friendly steps such as a hands-off attitude toward regulating mobile medical apps and health information technology. Now, many say securing government reimbursement is a bigger problem, but that's an entirely different story.
Some devices continue to make it to market with unresolved safety issues, like inferior vena cava filters for capturing blood clots before they reach the lungs.
"We must have national, publicly available registries of devices and procedures, so that we can track in real-time the outcomes, and then truly know the benefits and the risks," Redberg said.
The good news is that the FDA is taking steps toward those goals with initiatives like unique device identification and a recent proposal by the Brookings Institution to create a national public-private partnership for postmarket surveillance of medical devices.
- read the article in the WSJ