Problems with FDA Medical Device Approval Process Identified in New Studies

Two new studies have been published that are highly critical of the way the FDA approves medical devices for human use, saying that the agency requires too few clinical trials, and that often the data in those trials is suspect.

The new studies come as the FDA is under increasing scrutiny over how it decides which medical devices, such as pacemakers and stents, can be implanted in human beings. One study, conducted by researchers from the University of California and published this week in the Journal of the American Medical Association, found that two thirds of approved devices only went through one clinical trial before being unleashed on the market, and most of those trials involved less than 300 subjects. The other study, conducted by researchers from the FDA and Boston’s Beth Israel Deaconess Medical Center, will be published in the upcoming issue of the American Journal of Therapeutics, indicating that about 40% of the studies used to decide what devices are approved lack clear definitions of safety requirements.

The stakes in FDA’s medical device approval process are high following a 2008 Supreme Court decision in Riegel vs. Medtronic which determined that FDA approval can make medical device manufacturers immune from lawsuits for injuries caused by defective medical devices. As a consequence of that decision, thousands of pending medical device lawsuits have been dismissed, including cases filed on behalf of thousands of patients injured by the recalled Medtronic Sprint Fidelis defibrillator lead. Although the design of the Medtronic lead makes it prone to fracture or break, a federal judge ruled earlier this year that patient claims for medical expenses and other compensation are now barred because the FDA approved the device.

“Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias,” concluded the University of California researchers. They came to that finding after a review of 123 summaries of safety and effectiveness data for 78 high-risk cardiovascular devices approved from 2000 through 2007. The review found that 65% of the devices were approved after only one study, and 78% of the total number of studies had discrepancies between the number of patients enrolled and the number that was actually analyzed.

FDA officials have faulted the study for comparing the way medical devices are approved to the way drugs are approved, but the researchers say that the stakes are higher for medical devices, since patients can stop using drugs but dealing with faulty medical devices implanted in the body is a much more complex process. Industry officials say the researchers did not have access to all of the data provided to the FDA.

In the FDA and Beth Israel study, researchers found that the FDA used poorly defined safety and effectiveness goals, and studies had poor patient accounting, incomplete collection of patient information, and determined that the studies being conducted lacked representation by women, nonwhite populations and children.

“Manufacturers, regulators, and the clinical community should collaborate to address these study shortcomings to ensure that patients are treated with reliable, safe, and clinically useful medical devices,” researchers from that study concluded.

Since the Supreme Court ruling a number of agencies and studies have been focused on whether the FDA can actually carry the entire burden of being responsible for medical device safety. Uniformly, those studies have found the agency’s approval process lacking. This summer the Government Accountability Office (GAO) released a report that highlighted how FDA oversight of medical devices is inadequate, arguing that they are not an effective guardian of patient safety.

Congress is currently considering a bill called the Medical Device Safety Act of 2009, which seeks to clarify that FDA approval does not preempt lawsuits against medical device manufacturers, overturning the Supreme Court ruling. Opponents of the legislation say that enacting the Medical Device Safety Act of 2009 would stifle innovation and cannot be a substitute for strengthening the FDA.