Capitol Hill Hearing Examines FDA’s Device Clearance Process

The process is flawed. No it isn’t. It’s too slow. No, it’s moving too quickly. Trying to keep up with the varied opinions about the U.S. Food and Drug Administration (FDA) approval of new medical devices is enough to give you a sore neck.

During a recent hearing on Capitol Hill, lawmakers in the U.S. House of Representatives lawmakers attempted to rein in some of the back and forth, hearing arguments from different sides of the debate examining the FDA’s regulation of the $150 billion U.S. medical device industry.

Leaders at the FDA are in the process of overhauling the “510(k)” system, which is used to clear most devices. On the one side are device manufacturers who charge that FDA reviews have gotten longer and less predictable, forcing some companies to launch their devices overseas to stay in business. They say American patients no longer have access to the latest medical treatments, while putting at risk American innovation in an industry it has securely led.

Consumer safety advocates say just the opposite. They claim the FDA is clearing too many devices, too quickly, jeopardizing patient safety.

The hearing on the impact of FDA device regulations on U.S. jobs was held at the health subcommittee of the Energy and Commerce Committee.

The Energy and Commerce chairman, Fred Upton (R.-Mich.), criticized the regulatory process.

“Device companies are being forced to market their devices first in Europe,” he said. “This hearing aims to fix that.”Republican lawmakers including Leonard Lance of New Jersey, home to many device makers, stressed the role of medical-device manufacturers in the U.S. economy, saying that delays in product approvals threaten U.S. pre-eminence in the industry.

According to the head of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, M.D., the U.S. system is not inherently slower than Europe’s, though it does require an extra level of evidence. European regulators require that a device be safe and perform as described on its label. The FDA has those standards but also requires that the device be proven to successfully treat a disease or condition. Shuren points to a handful of devices that were rejected by the FDA and approved in Europe, only to later be recalled for safety reasons.

“There is significant underreporting of safety problems in some European countries, and it takes longer to identify safety problems in Europe,” Shurn said in written testimony.

The main problem the FDA has encountered in recent years, according to Shuren, is the declining quality of applications from device makers. Shuren claims that more than 50 percent of applications for conventional medical devices are missing key information, leading to delays that should have been avoided.

“We’re stepping up to the plate to do our part to get this right. But if it’s going to work we need industry to do their part,” Shuren told members of the subcommittee.

Also testifying were device industry entrepreneurs, who argued that the pace and unpredictability of FDA reviews is driving some companies into bankruptcy.

“Investment is drying up, companies are moving overseas or closing their doors and U.S. patients are being denied timely access to safe and effective new medical products,” said Josh Makower, M.D., a medical device inventor, a venture capital investor and consulting professor at Stanford University. Makower and the others pointed out that venture capital, which is critical to start-up companies, has dropped 37 percent across the device sector since 2007. While some of that decline is unquestionably due to the recession, entrepreneurs insist the FDA’s regulatory inconsistency also is to blame. Makower hammered home a key argument of device companies: that it typically takes companies two years longer to get devices approved in the U.S. than in Europe. That figure and others came from a survey sent to 750 device companies, in which only 17 percent responded.

PricewaterhouseCoopers released a similar report last month and its conclusions relied on a survey of just 13 companies.

Mark Deem of the Foundry LLC, a group of device entrepreneurs and investors in California, said the FDA sometimes makes “impossible” demands for “extraordinary” data from companies, which has cost the U.S. jobs.

Patient safety advocates claim the opposite is true.

Dr. Steven Nissen reiterated data from a study published this week suggesting the FDA is clearing too many devices through a fast-track pathway designed for low-risk devices. The analysis found that 70 percent of life-threatening recalls between 2005 and 2009 involved devices cleared through the speedier 510(k) method—which requires comparison to a predicate device already on the market, rather than a more rigorous system that clinical trial data. Devices that go through a longer, more strenuous premarket approval process—or PMA—usually are novel devices that require extensive clinical testing and data over the course of years. Most 510(k) applications don’t require extensive clinical testing.

“There’s a serious problem here when 112 million devices were recalled in less than five years,” said Nissen, chairman of cardiovascular medicine at the Cleveland Clinic.

But the FDA has questioned the significance of the numbers, since the devices recalled represent about 1 percent of those approved via 510(k). Also, since the agency approves 90 percent of its devices through the fast-track program it’s expected that more of those devices would be recalled.

According to the industry’s largest trade group, the Advanced Medical Technology Association, or AdvaMed, more than 99 percent of devices cleared in the 510(k) program haven’t been recalled, and warned that slowing down the program could harm patients.