Study Claims Devices Approved By FDA First, Rather Than E.U. Regulators, Are Safer
A new study suggests that devices first approved in the E.U. are three times more likely to have safety issues than devices first approved in the U.S. While Harvard researchers imply that Europe may be sacrificing safety for speed, industry advocates argue that Europe has recently taken steps to improve its oversight of medical devices and the issue is “complex.”
Regulatory processes are stricter in the U.S. than they are in the E.U., explained the researchers in a press release. The E.U. only requires clinical testing for some high-risk devices, and products can be approved if they “perform as intended” and are “likely to be safe.” By comparison, the FDA requires clinical testing for both efficacy and safety in most high-risk devices and has, on average, a slower regulatory process.
Legislators in the U.S. House of Representatives passed the 21st Century Cures Act last July with hopes of cutting through red tape and improving patient access to the latest in innovative medical technology and drugs. The bill’s proposed changes would redefine what evidence could be used to approve high-risk medical devices.
Harvard researcher Aaron Kesselheim told STAT News that the changes proposed by the House’s legislation would “move our regulatory system closer to the European system, at the same time that the people of Europe are trying to come up with proposals to move their system closer to ours.”
According to Kesselheim, the suspicion that the E.U. may be sacrificing safety for speed is corroborated by evidence in a study he co-led, recently published by BMJ. In it, researchers looked at 309 devices approved by the E.U. between 2005 and 2010, including 206 that also were approved by the FDA. Of those 309 devices, 63 percent were approved by the E.U. first, and 75 percent were approved for “major interventions.”
Devices approved by the E.U. first had three times as many safety recalls and alerts as devices approved by the FDA first, said researchers, numbers they they claim as evidence that “provides an important empirical measure of the trade-offs associated with the U.S. and E.U. frameworks for regulating medical devices.”
STAT News reports that the study still is under review at the Advanced Medical Technology Association (AdvaMed), but the group’s VP for global strategy and analysis, Ralph Ives, commented that the E.U.’s regulatory process has recently been strengthened and a comparison of the two systems “touches on a complex issue.”
The 21st Century Cures Act passed in the House despite dissension from some legislators, and the Senate could be hearing testimony on similar legislation in coming weeks, reported STAT News.
Meanwhile, Harvard researchers urge transparency and clearer communication to improve patient safety, according to the press release. “Patients and clinicians need access to, and balanced presentation of, the available evidence of safety and effectiveness of novel devices, as well as clear communication about the evidentiary gaps” so that they may “make truly informed decisions.”