WASHINGTON — Medical device companies have argued that streamlining the regulatory process at the Food and Drug Administration could help get their devices onto market more quickly and ultimately help save lives.
But a new study comparing US and European approaches to medical devices suggests that doing so could also carry significant risks for patient safety.
The two-continent study — led by Harvard Medical School researchers — comes as Congress is considering legislation that would make it easier to get drugs and medical devices through the regulatory process.
Currently, companies in the United States that want to sell high-risk devices, such as implants designed to support and sustain life, must first demonstrate that their products are reasonably safe and effective — usually through clinical trials.
In the European Union, by contrast, medical devices can be sold as long as they perform “as intended” and “are likely to be safe.” They generally get to market faster than in the US.
In the new study, published Tuesday in the BMJ, researchers found that medical devices that were first approved in the European Union were associated with a greater rate of safety issues than devices first approved by FDA.
Researchers examined 309 devices, 206 of which were approved by the FDA and the EU. Sixty-three percent were approved first in the EU.
The researchers found that the devices approved first by the EU were three times more likely to require safety alerts and recalls.
The study was led by Dr. Aaron S. Kesselheim, along with Thomas J. Hwang and Dr. Jessica M. Franklin, all of Harvard, as well as Elisaveta Sokolov of King’s College in London.
“There are well-known differences between the systems for device authorization in the US and the EU,” said Kesselheim. “I think there is a concern that the EU is trading speed for safety, and I think that’s what is borne out in the study.”
Kesselheim said the researchers did not expect to find such striking results.
The medical device industry has argued that the regulatory process can be streamlined without sacrificing patient safety.
One of the industry’s major trade groups, the Advanced Medical Technology Association, said it was reviewing the BMJ study but cautioned that it “touches on a complex issue” that may make it difficult to compare the US and European systems.
“It is important to note that the EU has recently taken steps to significantly strengthen its oversight of medical devices,” said Ralph Ives, the group’s executive vice president for global strategy and analysis.
Kesselheim said he believes speeding up the approval process for devices in the United States would be problematic.
It “moves our regulatory system closer to the European system, at the same time that the people in Europe are trying to come up with proposals to move their system closer to ours,” he said.
A bill that would accelerate the approval of drugs and medical devices, known as the 21st Century Cures Act, passed the House late last year. The Senate could consider its own version of the legislation in the coming weeks.