The official who oversees medical device safety for the Food and Drug Administration (FDA) recently said he wants the United States to be the “first” to approve medical devices, raising concerns among public health advocates that the agency isn’t taking efforts to reform the device industry seriously enough.
Dr. Jeffrey Shuren, the director of the FDA’s medical devices division under both the Obama and Trump administrations, earlier this year agreed to speak at a conference attended by medical device executives, according to a new report by the Associated Press.
At the conference, which cost executives $1,000 a head to attend, Shuren reportedly said that the FDA’s goal was to be “first in the world” to approve new devices. He also said he wanted the agency to remove “unnecessary burdens” for companies hoping to get their devices approved.
Such a goal may be at odds with what public health advocates say is a need to reform medical device regulation. Dr. Peter Lurie, a former FDA official who now heads the watchdog the Center for Science in the Public Interest, told the Associated Press that Shuren’s comments essentially offered device executives “an invitation to a race to the bottom for scientific standards.”
“Fatally flawed” system
The medical device industry already faces lower barriers for approval than the drug industry does, despite the fact that many medical devices are intended to be permanent implants or can leave lifelong impacts on a person’s body.
“If you're going to have something implanted in your body for potentially the rest of your life, wouldn’t you like it to be really well-tested beforehand? Is that really too much to ask?” Dr. Diana Zuckerman, a health policy analyst and head of the National Center of Health Research, told ConsumerAffairs earlier this year.
Independent researchers for years have said that the medical device approval process in the U.S. is “fatally flawed.”
More recently, a Netflix documentary called The Bleeding Edge exposed the tragic, life-long effects that four failed medical implants had on nearly 70 patients interviewed for the film.
Looking for improvement
Regulators in the United States and abroad are now promising to put safety at the forefront of medical device regulation.
Shortly before Thanksgiving, FDA Commissioner Scott Gottlieb, who was portrayed in the Netflix film as being in the industry’s pocket, announced new plans for the agency to “create a more robust medical device safety net for patients through better data.”
A similar call to reform medical device regulations is also currently taking place in Europe. In the United Kingdom, the Royal College Of Surgeons recently called for “drastic regulatory changes” after an investigative report by a group of European journalists published yesterday linked 83,000 deaths and 1.7 million injuries to faulty medical devices.
But while medical devices face low scrutiny from European regulators, the socialized healthcare systems abroad are at least more hesitant about allowing such devices to actually be used in surgery, experts say.
“In Europe, it’s very easy to get something on the market, but the national health plans won’t pay for it if it’s not proven to be safe and effective,” Zuckerman of the National Center for Health Research previously told ConsumerAffairs.
It’s not that Europeans aren’t reporting injuries from faulty devices. However, those who do tend to be wealthier people who opted for private insurance over the public plans.