FDA Approves High-Risk Heart Devices On Scant Scientific Evidence: Study

The findings of a new study raises serious questions about the effectiveness of the medical device approval process in the United States, highlighting more than a dozen times regulators approved heart devices under a “Priority Review” process, which were later deemed to be ineffective. 

In a report published in the medical journal JAMA Internal Medicine on August 27, researchers with the University of California San Francisco School of Medicine found that cardiovascular devices approved by the FDA through the “Priority Review” program were often based on studies with little scientific evidence to establish that they are safe or effective.

Researchers evaluated randomized clinical trials done to provide evidence for cardiovascular devices approved during premarket approval by the FDA. The report indicates that as a device moves through the Priority Review program, the thoroughness and quality of the scientific evidence used to justify approval of the product is not known or evaluated.

The study reviewed evidence provided to federal regulators for 14 high-risk cardiovascular devices introduced between 2007 and 2017, each of which were approved by the FDA under Priority Review. Of the 29 total devices approved under the Priority Review process during that time period, 14 were high-risk heart devices. A total of 18 studies were used to support that those 14 devices were safe and effective.

According to the findings, none of the 18 studies were double blind trials, a research benchmark that is commonly used to provide high quality data. At least 13 of the studies used surrogate end points, and the studies were not large scale, only enrolling an average of 500 patients.

There were nine FDA safety expert advisory panels convened to review the safety and effectiveness of the devices, and four found that the devices were safe, but did not find the devices to be effective in treating the cardiovascular issue in question. However, the devices were still approved. For 13 of the 14 devices, the FDA called for post-approval studies to be completed to provide further information.

As of May 23, 2018, there have been two Class I and 13 Class II recalls for six of the devices. Earlier this year, Medtronic heart implants were recalled due to defects that prevented the products from providing life-saving shocks, which was one of the products involved in the recent report.

Authors of this new study warn the majority of the heart devices that were recalled were approved based on a single nonrandomized, non-blinded study. They are calling for a new process to be defined for Priority Review during premarket approval.

“To lower the odds of recall the new program should demand high-quality pre-approval data, larger scale studies, and longer followup,” the study authors wrote.

The emphasis for high quality research for approvals stands against the FDA’s recent push to make medical device approvals easier and faster. Additionally, this year the FDA announced an action plan to streamline the premarket and post-market process, while spurring innovation.

Bringing devices to market quicker and integrating the premarket and post-market processes only deepens the concerns that unsafe devices are coming to market via a rushed and ineffective approval process.

Study authors called for the FDA to take steps to make sure post-market studies are done during a specified time limit. That way if any further problems are discovered, such as those that might warrant a recall, the post-market study might help to pick up those problems.