In November, the International Consortium of Investigative Journalists released a global investigation of medical device safety issues, drawing attention to the lack of regulation of medical devices and the substantial harm this has caused across the world.
In response to this campaign, the US Food and Drug Administration (FDA) unveiled a list of reforms they say will be “transformative” for medical device approval. But as Shannon Brownlee and Jeanne Lenzer argue in a recent Washington Post op-ed, these reforms will have very little impact on patient safety, because they don’t change the fundamental flaw in the medical device approval process — the fact that most medical devices can still be approved without undergoing any clinical trials in humans.
“The FDA’s promised transformation is mere window dressing” – Shannon Brownlee & Jeanne Lenzer
About 80 percent of medical devices are approved through a process called the 510(k) pathway, which allows devices to be approved without a clinical trial, as long as the new device is similar enough to an already existing “predicate” device. The FDA’s plan to fix the gaps in regulation is to recommend that companies cite predicate devices no older than 10 years, a non-mandatory policy that device companies can easily circumvent.
Underpinning the problems with medical device regulation is the fact that the FDA is a “captive agency” of industry, write Brownlee and Lenzer. The FDA relies on industry fees for 35% of their budget, and many of the scientists that work at the FDA either come from industry or later go on to work in industry (a phenomenon known as the “revolving door.”) As a result, the FDA sees drug and device companies as its primary customers, not patients.
The FDA sees drug and device companies as its primary customers, not patients.
What kind of regulations would result in real change for patients? Brownlee and Lenzer suggest several policies, including: requiring all implanted devices to undergo clinical trials before approval; create registries that track device outcomes; give the FDA sufficient public funding; and demand that FDA leadership be free from financial conflicts of interest.
Brownlee and Lenzer’s op-ed has already garnered more than 350 comments in just a few days. Read the full piece and join the conversation at The Washington Post.