The Institute of Medicine was right to dub the FDA’s 510(k) medical device program unfixable, at least according to the New England Journal of Medicine.
The process of using existing or "predicate" devices as the basis for evaluating the safety and effectiveness of a new device is "untenable," according to an editorial in the respected medical journal. The authors recommend that the FDA immediately stop using the protocol for Class III devices – considered to pose the highest potential risks to patients.
"As devices have evolved and become more complex, our device-approval system has become incapable of assuring safety and effectiveness," wrote NEJM executive editor Dr. Gregory Curfman and Dr. Rita Redberg, editor of the Archives of Internal Medicine. "The system we use today was created 35 years ago in an era of much simpler and fewer devices, and it is now outdated."
Although the IOM’s findings met with instant industry condemnation and wariness from the federal watchdog agency, the NEJM editorial backed the call for more stringent review of medical devices that are getting to market without undergoing clinical trials.
Rebuffing concerns that the more extensive review poses a burden that could threaten jobs, the authors point to the ongoing billion-dollar lawsuits over Johnson & Johnson (NYSE:JNJ) subsidiary Depuy Orthopaedics’ metal-on-metal hip implants, which were found to shed minute metal particles into patients’ bloodstreams over time.
"[T]he disastrous outcomes of the use of DePuy ASRs show that rushing untested and potentially dangerous medical devices into the marketplace carries serious risks; our regulators should not be in the business of creating jobs in the manufacture of dangerous devices," Curfman and Redberg wrote.
The FDA commissioned to IOM for a soup-to-nuts review of the 510(k) program in late 2009. The long-awaited report, which dropped late last month, recommended that the agency ditch the program entirely and replace it with an "integrated pre-market and post-market regulatory framework."
"It’s not clear that the 510(k) process is serving the needs of either the industry or patients, and simply modifying it again will not help," said David Challoner, who chaired the committee that wrote the report. "The 510(k) process cannot achieve its stated goals – to promote innovation and make safe, effective devices available to patients in a timely manner – because they are fundamentally at odds with the statutes that govern how FDA must implement the process."
Other recommendations included boosting postmarket surveillance and strengthening the FDA’s postmarket authority.
Even before the report went public, the med-tech industry was on the attack. Even the FDA sought to distance itself from the IOM’s recommendations, emphasizing that it was “not bound” by the findings.
The reaction from the medical device industry was swift and condemnatory.
"The report’s conclusions do not deserve serious consideration from the Congress or the Administration," said Stephen Ubl, president and CEO of the Advanced Medical Technology Assn., in prepared remarks. "It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure. This would be a disservice to patients and the public health."
The NEJM editorial insists that the 510(k) process is no boon to industry or to patients and urges the agency to consider some immediate steps while the report’s long-term recommendations are mulled:
- Ban all Class III devices, those of highest risk, from the 510(k) fast-track process;
- Eliminate clearance using multiple predicate devices, by which a new device can be cleared by demonstrating equivalence to a device that was also cleared through equivalence, forming a chain of devices that were never clinically tested and;
- Implement a formal postmarket surveillance program.
"We believe that the IOM report is insightful, judicious, sensible, and long overdue," according to the NEJM piece. "We support the IOM committee’s recommendation that the 510(k) process be replaced with an evaluation of safety and effectiveness. It is important to maintain and encourage innovation in medical devices. But true innovation requires that safety and effectiveness be proven by scientific study in clinical trials."
The FDA is gathering comment on the IOM report and a public meeting is scheduled for September 16, 2011, at 8:30 a.m. at the Silver Spring Hilton Hotel in Silver Spring, Md.