First published 2/14/11 on Gooz News
Over the past several months, as my colleague Allison Bass pointed out last week, the medical device industry has launched a preemptive campaign to blunt the Food and Drug Administration’s long overdue overhaul of the way it approves joints, stents, pumps and other medical devices inserted in millions of American bodies every year. Triggered in 2009 by the ReGen Menaflex scandal, the FDA device review over the Obama administration’s first two years focused on the 510(k) approval process, which allows devices deemed substantially equivalent to previously approved devices to slide through their FDA approval process without undergoing clinical trial testing in humans. Recognizing that the law had created a huge loophole for devices whose malfunctioning would pose a serious risk to human health, the FDA asked the Institute of Medicine to conduct a full-scale investigation into the device review process. That report is due in June.
That was before last November’s election. The news out of the FDA in the few weeks since the president announced his effort to purge “needless” government regulations to help small business create jobs has signaled the 510(k) review may be in jeopardy. Last week, the FDA announced plansto create a fast-track review process for especially innovative medical devices, which was followed a day later by a major article in the New York Times business section highlighting complaints by a few small device manufacturers and venture capitalists that the FDA review process had become too stringent and was chasing jobs abroad.
Today, a new study in the Archives of Internal Medicine (subscription required) provides the sobering counterpoint to this industry-generated public relations offensive. After reviewing every FDA recall of medical devices between 2005 and 2009, authors Diana Zuckerman and Paul Brown of National Research Center for Women & Families and Steve Nissen of the Cleveland Clinic found that only 21 of 113 recalls of devices whose malfunction could cause serious health problems or death went through clinical trial testing prior to approval. Fully 78 percent received either a cursory or no review, with sensitive cardiovascular devices like internal and external defibrillators accounting for nearly a third of the recalls.
This comes as no surprise, since every report that has looked at this relatively obscure regulatory arena has found the same thing. A 2009 Government Accountability Office report found that more Class III (high-risk devices whose malfunctioning would pose a serious risk to health or death) got cleared through the 510(k) process between 2003 and 2007 than through the more stringent pre-market approval (PMA) process, which requires clinical trial testing. “Although Congress envisioned that class III devices would be approved through the more stringent PMA process, and the Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III device types, this process remains incomplete,” the GAO noted in its typically dry and understated fashion.
In an editorial accompanying the Zuckerberg study, Archives editor Rita Redberg and Sanket Dhruva pointed out the gravity of the public health disasters that have been associated with a few of the more high-profile device recalls. “Hundreds of deaths have been attributed to automated external defibrillator malfunctions, while it remains unclear how many lives these devices may have saved,” they wrote. They also noted that the Sprint Fidelis implantable cardioverter-defibrillator made by Medtronic, which had to be recalled for faulty wire leads after it passed FDA muster in 2004 without going through PMA trials, has caused at least 13 deaths and led to an undetermined number of inappropriate shocks to the 268,000 Americans walking around with this potentially faulty time bomb inside their bodies.
For their part, industry officials offer zero data to back their claims that requiring clinical trials on high-risk devices will “chill device innovation,” Redberg and Dhruva wrote. Indeed, the industry trade group Advamed, in its own report, found the same number of recalls of Class III devices approved through the 510(k) process as the Zuckerberg group. The only difference? Advamed spun the numbers as a “good record.”
The FDA needs to keep its review of the 510(k) process on track. It should wait for the final IOM report before issuing new rules, and ignore pressure emanating from the device industry or House committees that are now in the hands of industry-backed deregulatory zealots like Rep. Darrell Issa (R-CA), who chairs the investigations subcommittee of the Government Oversight and Reform panel. That committee used to be run Rep. Henry Waxman (D-CA), who did yeoman-like work in exposing flaws in the FDA’s regulatory process.
In previous years, the drug industry successfully played the innovation card to pad prices. The device industry is now using innovation as an excuse to rush products to market that could put public health and safety at risk if improperly vetted. This is a far more serious matter.
Merrill Goozner is an independent journalist writing at Gooz News.